GUBamy

updated

GUBamy, GUB014295 and ABBV-295 are one investigational long-acting amylin analogue, discovered by Gubra and licensed to AbbVie. All efficacy and safety data are company announcements of phase 1 results and none is peer reviewed: in the most detailed report, mean weight loss was 7.8 to 9.8% at week 12 in weekly cohorts versus about 0.3% on placebo in 60 adults with a mean BMI of 29.3. A phase 2 study began in August 2026.

Long-acting amylin analogue

  • ClinicalTrials.gov NCT06144684 lists GUB014295 with the other name GUBamy, and AbbVie's 10-Q names GUB014295 (ABBV-295). No INN or PubChem record exists.
  • AbbVie holds an exclusive global license from Gubra for obesity. The agreement was announced on 3 March 2025, and AbbVie's 10-Q dates it to April 2025.
  • The company reported on 30 September 2026 that in 60 adults (45 on ABBV-295, 15 on placebo, mean BMI 29.3, 88% men), least-squares mean weight loss was 7.8 to 9.8% at week 12 in weekly cohorts versus about 0.3% on placebo.
  • The company reported a half-life of 270 hours (11 days) in early releases and 10.7 to 12.3 days in the 30 September 2026 report.
  • In that report, nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, and 4.4% versus 0.0% discontinued for gastrointestinal events.
  • A phase 2 study (NCT07752979, estimated 360 adults) started on 4 August 2026 with no results, and no peer-reviewed paper with the phase 1 results was found.

What is GUBamy, and is it approved?

GUBamy, GUB014295 and ABBV-295 are one investigational long-acting amylin analogue, discovered by Gubra and licensed to AbbVie. FDA database searches on 10 October 2026 found no application or label, and company releases state it has not been approved by any regulator worldwide.

Gubra's release of 13 November 2024 says "GUBamy (GUB014295)" is an investigational long-acting amylin analogue. ClinicalTrials.gov NCT06144684 lists the intervention as GUB014295 with the other name GUBamy, sponsored by AbbVie. AbbVie's release of 9 March 2026 calls the study drug "ABBV-295 (GUB014295)" and cites NCT06144684, and AbbVie's 10-Q for the period ended 30 June 2026 names "GUB014295 (ABBV-295)". Gubra says it discovered the compound with its streaMLine platform and describes the drug product as a sterile neutral-pH solution.

The sources reviewed give no INN, and the WHO proposed INN lists 126 to 135, which print no development codes, contain amylin-class names that could not be tied to GUB014295. PubChem returned no record for GUB014295, GUBamy or ABBV-295, so no structure or molecular weight is public in the records reviewed.

AbbVie and Gubra announced a license agreement on 3 March 2025, when GUB014295 was in a phase 1 trial. AbbVie's 10-Q for the period ended 30 June 2026 dates the agreement to April 2025 and says AbbVie received an exclusive global license to develop and commercialize GUB014295 (ABBV-295) for obesity. Gubra's 1 April 2025 release says all regulatory conditions were satisfied on 28 March 2025. Financial terms are in the filing and are not repeated here.

openFDA Drugs@FDA queries for GUBamy, GUB014295 and ABBV-295 each returned "No matches found" on 10 October 2026, while a control query for semaglutide returned records, and DailyMed drug name searches for the same three names returned 0 labels. The company releases state that ABBV-295 has not been approved by any health regulatory authority worldwide.

Registry: first-in-human phase 1, UK, 76 participants, completed, no posted results

Trial registry record

ClinicalTrials.gov. NCT06144684 (sponsor AbbVie).

NCT06144684 lists the intervention as GUB014295 with the other name GUBamy, sponsored by AbbVie. It is a two-part, single-centre, randomized, placebo-controlled phase 1 in the United Kingdom with 76 participants (actual), started on 29 November 2023 and completed on 5 January 2026, with safety primary outcomes (adverse events, vital signs, laboratory safety). The registry has no posted results.

Participants / model
Lean to overweight or obese but otherwise healthy adults
Treatment
Subcutaneous single and multiple ascending doses
Follow-up
29 November 2023 to 5 January 2026
Study design
Official trial registry
Funding
not stated in the source

A registration is not an outcome, and the efficacy results on this page are company statements only.

Read the original source
Company statement, 13 November 2024: single dose, weight down about 3% over 6 weeks

Clinical trial

Gubra. Company release dated 13 November 2024 on GUBamy phase 1 single ascending dose data.

Gubra's release calls "GUBamy (GUB014295)" an investigational long-acting amylin analogue. Six cohorts were randomized 6:2 to GUBamy or placebo. Mean body weight fell by about 3% over 6 weeks in the three highest dose groups (3.5 to 6.0 mg; 1.81 to 3.25% across timepoints) while the placebo group gained about 1% (0.52 to 1.25%). The half-life was 270 hours (11 days) with dose-proportional exposure. The most frequent adverse events were gastrointestinal and dose dependent: nausea and reduced appetite (frequent) and vomiting (occasional), mostly mild and transient. The release said the data would be presented at a future conference.

Participants / model
Healthy lean and overweight men, mean BMI 26.65
Treatment
Single subcutaneous dose
Follow-up
Body weight over 6 weeks
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

A company statement dated 13 November 2024. No peer-reviewed report was found.

Read the original source
Company statement, 9 March 2026: multiple dose topline, 76 enrolled, weight loss 7.75 to 9.79% at week 12

Clinical trial

AbbVie. Company release dated 9 March 2026 on topline phase 1 multiple ascending dose results for ABBV-295.

AbbVie calls the study drug "ABBV-295 (GUB014295)" and cites NCT06144684. Doses of 2 to 14 mg were tested with different escalations and frequencies in adults with a mean BMI under 30, 88.3% male, and the release says 76 participants were enrolled in the MAD study. Least-squares mean weight change ranged from a loss of 7.75% to 9.79% at week 12 in the weekly groups (cohorts 3, 4 and 5a), a loss of 9.73% at week 13 in the every-other-week group and 7.86% at week 13 in the monthly group (monthly after week 5), versus losses of 0.26% and 0.25% on placebo at weeks 12 and 13. The release says ABBV-295 was generally well tolerated, with gastrointestinal events mostly mild and mostly in the first 6 weeks. A footnote says participants unable to continue treatment were withdrawn with no further efficacy data collected.

Participants / model
Adults with a mean BMI under 30 (healthy lean to overweight)
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
Percent change in body weight at weeks 12 and 13
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

The registry lists 76 as the enrollment for the whole two-part trial, and the release's 76 for the MAD study is not reconciled with it. Participants who could not continue were withdrawn with no further efficacy data collected.

Read the original source
AbbVie 10-Q, period ended 30 June 2026: exclusive global license from Gubra

Regulatory record

AbbVie Form 10-Q for the period ended 30 June 2026. SEC EDGAR.

The filing names "GUB014295 (ABBV-295)" and dates the AbbVie and Gubra license agreement to April 2025. It says AbbVie received an exclusive global license to develop and commercialize GUB014295 (ABBV-295) for obesity. Financial terms are in the filing and are not repeated here.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Period ended 30 June 2026
Study design
Company filing
Funding
not stated in the source

AbbVie and Gubra announced the license agreement on 3 March 2025, when GUB014295 was in a phase 1 trial, and Gubra's 1 April 2025 release says all regulatory conditions were satisfied on 28 March 2025. The 10-Q's April 2025 date and the 3 March 2025 announcement date are not reconciled.

Read the original source
FDA record search, 10 October 2026: no application or label

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA queries and DailyMed drug name searches for GUBamy, GUB014295 and ABBV-295, run on 10 October 2026.

openFDA Drugs@FDA queries for GUBamy, GUB014295 and ABBV-295 each returned "No matches found" (a control query for semaglutide returned records), and DailyMed drug name searches for the same three names returned 0 labels. The company releases state that ABBV-295 has not been approved by any health regulatory authority worldwide.

Participants / model
FDA databases, not a clinical population
Treatment
Name search
Follow-up
Queries run on 10 October 2026
Study design
Dated US approval-record search, plus company statements
Funding
not stated in the source

A search result shows what the databases returned on that date. It is US-scoped. The worldwide statement comes from the companies, not from a regulator.

Read the original source

What did the phase 1 studies find?

All human results are company statements and none is peer reviewed. The company reported mean weight loss of 7.8 to 9.8% at week 12 in weekly cohorts versus about 0.3% on placebo in 60 adults with a mean BMI of 29.3, and a half-life of about 11 days.

In a company statement dated 13 November 2024, Gubra reported single ascending dose results. Six cohorts of healthy lean and overweight men (mean BMI 26.65) were randomized 6:2 to GUBamy or placebo. Mean body weight fell by about 3% over 6 weeks in the three highest dose groups (3.5 to 6.0 mg; 1.81 to 3.25% across timepoints) while the placebo group gained about 1% (0.52 to 1.25%). The half-life was 270 hours (11 days) with dose-proportional exposure. The release said the data would be presented at a future conference.

In a company statement dated 1 April 2025, Gubra reported interim multiple ascending dose part A results. The first two cohorts received 1 mg or 2 mg once weekly for 6 weeks and were followed for 6 more weeks. Least-squares mean weight change on day 43 was a 7.77% loss in the 2 mg cohort versus a 1.99% gain on placebo, and half-life was 270 hours (11 days). Mean BMI was 27.63 in the placebo group and 24.33 in the 2 mg cohort, so the groups were not matched at baseline, and cohort sizes were not stated.

In a company statement dated 9 March 2026, AbbVie reported topline multiple ascending dose results. Doses of 2 to 14 mg were tested with different escalations and frequencies in adults with a mean BMI under 30, 88.3% male, and the release says 76 participants were enrolled in the MAD study. Least-squares mean weight change ranged from a loss of 7.75% to 9.79% at week 12 in the weekly groups (cohorts 3, 4 and 5a), a loss of 9.73% at week 13 in the every-other-week group and 7.86% at week 13 in the monthly group (monthly after week 5), versus losses of 0.26% and 0.25% on placebo at weeks 12 and 13. A footnote says participants unable to continue treatment were withdrawn with no further efficacy data collected. The registry lists 76 as the enrollment for the whole two-part trial, and the two counts are not reconciled.

In a company statement dated 30 September 2026, Gubra reported detailed data presented by AbbVie as a short oral presentation at EASD 2026. The 60 participants in MAD part 2B and 2C were randomized to ABBV-295 (n = 45) or placebo (n = 15), with a mean age of 41.5 years, mean BMI 29.3 and 88% male, for 12 or 13 weeks at 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly. Mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours. Least-squares mean weight loss was 7.8 to 9.8% at week 12 in the weekly cohorts, 9.7% in the every-other-week cohort and 7.9% in the monthly cohort at week 13, versus about 0.3% on placebo. The EASD abstract and AbbVie's release of the same date were not retrieved, so these figures come from Gubra's release only.

Company statement, 13 November 2024: single dose, weight down about 3% over 6 weeks

Clinical trial

Gubra. Company release dated 13 November 2024 on GUBamy phase 1 single ascending dose data.

Gubra's release calls "GUBamy (GUB014295)" an investigational long-acting amylin analogue. Six cohorts were randomized 6:2 to GUBamy or placebo. Mean body weight fell by about 3% over 6 weeks in the three highest dose groups (3.5 to 6.0 mg; 1.81 to 3.25% across timepoints) while the placebo group gained about 1% (0.52 to 1.25%). The half-life was 270 hours (11 days) with dose-proportional exposure. The most frequent adverse events were gastrointestinal and dose dependent: nausea and reduced appetite (frequent) and vomiting (occasional), mostly mild and transient. The release said the data would be presented at a future conference.

Participants / model
Healthy lean and overweight men, mean BMI 26.65
Treatment
Single subcutaneous dose
Follow-up
Body weight over 6 weeks
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

A company statement dated 13 November 2024. No peer-reviewed report was found.

Read the original source
Company statement, 1 April 2025: interim multiple dose part A, 7.77% loss at 2 mg on day 43

Clinical trial

Gubra. Company release dated 1 April 2025 on interim multiple ascending dose part A results for GUBamy.

In multiple ascending dose part A, the first two cohorts received 1 mg or 2 mg once weekly for 6 weeks and were followed for 6 more weeks. Least-squares mean weight change on day 43 was a 7.77% loss in the 2 mg cohort versus a 1.99% gain on placebo. Half-life was 270 hours (11 days). All related adverse events were mild, and the most frequent were dose dependent and gastrointestinal.

Participants / model
Healthy lean and overweight subjects
Treatment
Subcutaneous once weekly for 6 weeks
Follow-up
Weight on day 43
Study design
Company statement of interim phase 1 results; not peer reviewed
Funding
not stated in the source

Mean BMI was 27.63 in the placebo group and 24.33 in the 2 mg cohort, so the groups were not matched at baseline. Cohort sizes were not stated.

Read the original source
Company statement, 9 March 2026: multiple dose topline, 76 enrolled, weight loss 7.75 to 9.79% at week 12

Clinical trial

AbbVie. Company release dated 9 March 2026 on topline phase 1 multiple ascending dose results for ABBV-295.

AbbVie calls the study drug "ABBV-295 (GUB014295)" and cites NCT06144684. Doses of 2 to 14 mg were tested with different escalations and frequencies in adults with a mean BMI under 30, 88.3% male, and the release says 76 participants were enrolled in the MAD study. Least-squares mean weight change ranged from a loss of 7.75% to 9.79% at week 12 in the weekly groups (cohorts 3, 4 and 5a), a loss of 9.73% at week 13 in the every-other-week group and 7.86% at week 13 in the monthly group (monthly after week 5), versus losses of 0.26% and 0.25% on placebo at weeks 12 and 13. The release says ABBV-295 was generally well tolerated, with gastrointestinal events mostly mild and mostly in the first 6 weeks. A footnote says participants unable to continue treatment were withdrawn with no further efficacy data collected.

Participants / model
Adults with a mean BMI under 30 (healthy lean to overweight)
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
Percent change in body weight at weeks 12 and 13
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

The registry lists 76 as the enrollment for the whole two-part trial, and the release's 76 for the MAD study is not reconciled with it. Participants who could not continue were withdrawn with no further efficacy data collected.

Read the original source
Company statement, 30 September 2026: 60 randomized, weight loss 7.8 to 9.8% at week 12, half-life 10.7 to 12.3 days

Clinical trial

Gubra. Company release dated 30 September 2026, reporting AbbVie's short oral presentation of detailed phase 1 data for ABBV-295 at EASD 2026.

The 60 participants in MAD part 2B and 2C were randomized to ABBV-295 (n = 45) or placebo (n = 15), mean age 41.5 years, mean BMI 29.3, 88% male, dosed at 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly for 12 or 13 weeks. Mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours. Least-squares mean weight loss was 7.8 to 9.8% at week 12 in the weekly cohorts, 9.7% in the every-other-week cohort and 7.9% in the monthly cohort at week 13, versus about 0.3% on placebo. Nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea by 20.0% versus 0.0%, and discontinuation for gastrointestinal events was 4.4% versus 0.0%. No serious treatment-emergent adverse events and no severe gastrointestinal events were reported. Gubra's release also says the phase 2 began in August 2026.

Participants / model
Adults, mean BMI 29.3, mostly men, 60 randomized
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
12 or 13 weeks
Study design
Company statement reporting a conference presentation of phase 1 results; not peer reviewed
Funding
not stated in the source

The EASD abstract and AbbVie's release of the same date were not retrieved, so these figures come from Gubra's release only.

Read the original source

Has any of it been peer reviewed, and what is registered?

No peer-reviewed paper with the phase 1 results was found. The first-in-human trial (NCT06144684, 76 participants, completed 5 January 2026) is registered with no posted results, so every efficacy figure on this page is a company statement.

PubMed queries on 10 October 2026 for ABBV-295, GUBamy and GUB014295 returned 1, 0 and 0 records. The one record is a 2026 narrative review (Alhazmi and le Roux, PMID 42452898) whose table repeats the company-reported ABBV-295 figures (about 9.8% at 12 weeks, 76 participants) and adds no independent data. No peer-reviewed paper with the phase 1 results was found.

The first-in-human trial, NCT06144684, is a two-part, single-centre, randomized, placebo-controlled phase 1 in the United Kingdom with 76 participants (actual), started on 29 November 2023 and completed on 5 January 2026, with safety primary outcomes. The registry has no posted results. A registration is not an outcome, and the results above are company statements only.

PubMed search, 10 October 2026: one review repeating company figures, no phase 1 paper

PubMed search record

PubMed searches run on 10 October 2026 for ABBV-295, GUBamy and GUB014295, returning 1, 0 and 0 records.

The queries returned 1, 0 and 0 records. The one record is the 2026 narrative review by Alhazmi and le Roux (PMID 42452898), whose table repeats the company-reported ABBV-295 figures (about 9.8% at 12 weeks, 76 participants) and adds no independent data. No peer-reviewed paper with the phase 1 results was found.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

Read the original source
Registry: first-in-human phase 1, UK, 76 participants, completed, no posted results

Trial registry record

ClinicalTrials.gov. NCT06144684 (sponsor AbbVie).

NCT06144684 lists the intervention as GUB014295 with the other name GUBamy, sponsored by AbbVie. It is a two-part, single-centre, randomized, placebo-controlled phase 1 in the United Kingdom with 76 participants (actual), started on 29 November 2023 and completed on 5 January 2026, with safety primary outcomes (adverse events, vital signs, laboratory safety). The registry has no posted results.

Participants / model
Lean to overweight or obese but otherwise healthy adults
Treatment
Subcutaneous single and multiple ascending doses
Follow-up
29 November 2023 to 5 January 2026
Study design
Official trial registry
Funding
not stated in the source

A registration is not an outcome, and the efficacy results on this page are company statements only.

Read the original source

Has phase 2 started?

Yes. NCT07752979 (AbbVie), a randomized phase 2 dose-finding study in an estimated 360 adults with obesity or overweight and a comorbidity, started on 4 August 2026. It is recruiting with no results, so the phase 1 label is out of date.

NCT07752979 is a randomized, quadruple-masked phase 2 dose-finding study of ABBV-295 in adults with obesity or overweight and a weight-related comorbidity, estimated 360 participants at about 70 sites in the United States and Puerto Rico, started on 4 August 2026, with a primary outcome of percent change in body weight at week 32 and adverse events to about week 52. The drug is given subcutaneously in pre-filled syringes. It is recruiting and has no results. Gubra's release of 30 September 2026 also says the phase 2 began in August 2026.

Further phase 1 studies are registered with no posted results: NCT07291232 (adults with obesity, estimated 80, recruiting), NCT07414784 (women taking oral contraceptives, 20, completed) and NCT07514260 (Japanese participants with overweight or obesity, 24, active not recruiting). No interaction or ethnic-sensitivity data are public in the records reviewed.

Registry: phase 2, about 360 planned, started 4 August 2026, recruiting

Trial registry record

ClinicalTrials.gov. NCT07752979 (sponsor AbbVie).

NCT07752979 is a randomized, quadruple-masked phase 2 dose-finding study of ABBV-295 in adults with obesity or overweight and a weight-related comorbidity, estimated 360 participants at about 70 sites in the United States and Puerto Rico, started on 4 August 2026, with a primary outcome of percent change in body weight at week 32 and adverse events to about week 52. It is recruiting and has no results.

Participants / model
Adults with obesity or overweight (planned)
Treatment
Subcutaneous in pre-filled syringes
Follow-up
Primary outcome at week 32 (planned)
Study design
Official trial registry
Funding
not stated in the source

A registration, not an outcome. Gubra's 30 September 2026 release also says the phase 2 began in August 2026.

Read the original source
Registry: three more phase 1 studies, no posted results

Trial registry record

ClinicalTrials.gov. NCT07291232, with related records NCT07414784 and NCT07514260.

Further phase 1 studies are registered with no posted results: NCT07291232 (adults with obesity, estimated 80, recruiting), NCT07414784 (women taking oral contraceptives, 20, completed) and NCT07514260 (Japanese participants with overweight or obesity, 24, active not recruiting). No interaction or ethnic-sensitivity data are public in the records reviewed.

Participants / model
Not a clinical population
Treatment
Subcutaneous
Follow-up
Not applicable
Study design
Official trial registry
Funding
not stated in the source

Registrations, not outcomes.

Read the original source
Company statement, 30 September 2026: 60 randomized, weight loss 7.8 to 9.8% at week 12, half-life 10.7 to 12.3 days

Clinical trial

Gubra. Company release dated 30 September 2026, reporting AbbVie's short oral presentation of detailed phase 1 data for ABBV-295 at EASD 2026.

The 60 participants in MAD part 2B and 2C were randomized to ABBV-295 (n = 45) or placebo (n = 15), mean age 41.5 years, mean BMI 29.3, 88% male, dosed at 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly for 12 or 13 weeks. Mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours. Least-squares mean weight loss was 7.8 to 9.8% at week 12 in the weekly cohorts, 9.7% in the every-other-week cohort and 7.9% in the monthly cohort at week 13, versus about 0.3% on placebo. Nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea by 20.0% versus 0.0%, and discontinuation for gastrointestinal events was 4.4% versus 0.0%. No serious treatment-emergent adverse events and no severe gastrointestinal events were reported. Gubra's release also says the phase 2 began in August 2026.

Participants / model
Adults, mean BMI 29.3, mostly men, 60 randomized
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
12 or 13 weeks
Study design
Company statement reporting a conference presentation of phase 1 results; not peer reviewed
Funding
not stated in the source

The EASD abstract and AbbVie's release of the same date were not retrieved, so these figures come from Gubra's release only.

Read the original source

Is GUBamy an AbbVie amylin analogue in phase 1?

Mostly. The code and the AbbVie license from Gubra are confirmed, and AbbVie's own filing states the license, but the phase 1 label is out of date because a phase 2 started in August 2026. All efficacy figures are company statements.

The claim describes an AbbVie amylin analog licensed from Gubra, in phase 1.

GUBamy is Gubra's name for GUB014295, now numbered ABBV-295 by AbbVie, and AbbVie's 10-Q confirms an exclusive global license from Gubra for obesity. The phase 1 label is out of date: NCT07752979, a phase 2 dose-finding study, started on 4 August 2026.

All efficacy and safety figures are company statements from phase 1 studies of 12 to 13 weeks in participants with a mean BMI of 29.3 and 88% men in the most detailed report. One baseline BMI imbalance was disclosed in the interim report, and no phase 2 result exists.

AbbVie 10-Q, period ended 30 June 2026: exclusive global license from Gubra

Regulatory record

AbbVie Form 10-Q for the period ended 30 June 2026. SEC EDGAR.

The filing names "GUB014295 (ABBV-295)" and dates the AbbVie and Gubra license agreement to April 2025. It says AbbVie received an exclusive global license to develop and commercialize GUB014295 (ABBV-295) for obesity. Financial terms are in the filing and are not repeated here.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Period ended 30 June 2026
Study design
Company filing
Funding
not stated in the source

AbbVie and Gubra announced the license agreement on 3 March 2025, when GUB014295 was in a phase 1 trial, and Gubra's 1 April 2025 release says all regulatory conditions were satisfied on 28 March 2025. The 10-Q's April 2025 date and the 3 March 2025 announcement date are not reconciled.

Read the original source
Registry: first-in-human phase 1, UK, 76 participants, completed, no posted results

Trial registry record

ClinicalTrials.gov. NCT06144684 (sponsor AbbVie).

NCT06144684 lists the intervention as GUB014295 with the other name GUBamy, sponsored by AbbVie. It is a two-part, single-centre, randomized, placebo-controlled phase 1 in the United Kingdom with 76 participants (actual), started on 29 November 2023 and completed on 5 January 2026, with safety primary outcomes (adverse events, vital signs, laboratory safety). The registry has no posted results.

Participants / model
Lean to overweight or obese but otherwise healthy adults
Treatment
Subcutaneous single and multiple ascending doses
Follow-up
29 November 2023 to 5 January 2026
Study design
Official trial registry
Funding
not stated in the source

A registration is not an outcome, and the efficacy results on this page are company statements only.

Read the original source
Registry: phase 2, about 360 planned, started 4 August 2026, recruiting

Trial registry record

ClinicalTrials.gov. NCT07752979 (sponsor AbbVie).

NCT07752979 is a randomized, quadruple-masked phase 2 dose-finding study of ABBV-295 in adults with obesity or overweight and a weight-related comorbidity, estimated 360 participants at about 70 sites in the United States and Puerto Rico, started on 4 August 2026, with a primary outcome of percent change in body weight at week 32 and adverse events to about week 52. It is recruiting and has no results.

Participants / model
Adults with obesity or overweight (planned)
Treatment
Subcutaneous in pre-filled syringes
Follow-up
Primary outcome at week 32 (planned)
Study design
Official trial registry
Funding
not stated in the source

A registration, not an outcome. Gubra's 30 September 2026 release also says the phase 2 began in August 2026.

Read the original source
Company statement, 30 September 2026: 60 randomized, weight loss 7.8 to 9.8% at week 12, half-life 10.7 to 12.3 days

Clinical trial

Gubra. Company release dated 30 September 2026, reporting AbbVie's short oral presentation of detailed phase 1 data for ABBV-295 at EASD 2026.

The 60 participants in MAD part 2B and 2C were randomized to ABBV-295 (n = 45) or placebo (n = 15), mean age 41.5 years, mean BMI 29.3, 88% male, dosed at 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly for 12 or 13 weeks. Mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours. Least-squares mean weight loss was 7.8 to 9.8% at week 12 in the weekly cohorts, 9.7% in the every-other-week cohort and 7.9% in the monthly cohort at week 13, versus about 0.3% on placebo. Nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea by 20.0% versus 0.0%, and discontinuation for gastrointestinal events was 4.4% versus 0.0%. No serious treatment-emergent adverse events and no severe gastrointestinal events were reported. Gubra's release also says the phase 2 began in August 2026.

Participants / model
Adults, mean BMI 29.3, mostly men, 60 randomized
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
12 or 13 weeks
Study design
Company statement reporting a conference presentation of phase 1 results; not peer reviewed
Funding
not stated in the source

The EASD abstract and AbbVie's release of the same date were not retrieved, so these figures come from Gubra's release only.

Read the original source
Company statement, 1 April 2025: interim multiple dose part A, 7.77% loss at 2 mg on day 43

Clinical trial

Gubra. Company release dated 1 April 2025 on interim multiple ascending dose part A results for GUBamy.

In multiple ascending dose part A, the first two cohorts received 1 mg or 2 mg once weekly for 6 weeks and were followed for 6 more weeks. Least-squares mean weight change on day 43 was a 7.77% loss in the 2 mg cohort versus a 1.99% gain on placebo. Half-life was 270 hours (11 days). All related adverse events were mild, and the most frequent were dose dependent and gastrointestinal.

Participants / model
Healthy lean and overweight subjects
Treatment
Subcutaneous once weekly for 6 weeks
Follow-up
Weight on day 43
Study design
Company statement of interim phase 1 results; not peer reviewed
Funding
not stated in the source

Mean BMI was 27.63 in the placebo group and 24.33 in the 2 mg cohort, so the groups were not matched at baseline. Cohort sizes were not stated.

Read the original source

How does GUBamy work, and how long does it last in the body?

Gubra describes GUBamy as a long-acting amylin analogue. In company-reported phase 1 data the half-life was 270 hours (11 days) in early releases and 10.7 to 12.3 days in the most detailed report.

Gubra describes GUBamy as an investigational long-acting amylin analogue discovered with its streaMLine platform, and the drug product as a sterile neutral-pH solution. No structure or molecular weight is public in the records reviewed, so nothing more about its chemistry or receptor activity is described here. The amylin mechanism has support from class data, such as the published phase 2 trial of petrelintide on its own page.

The company reported a half-life of 270 hours (11 days) with dose-proportional exposure in the single dose study and in interim multiple dose part A. In the 30 September 2026 report, mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours across the 60 participants in MAD part 2B and 2C. All of these are company statements.

Company statement, 13 November 2024: single dose, weight down about 3% over 6 weeks

Clinical trial

Gubra. Company release dated 13 November 2024 on GUBamy phase 1 single ascending dose data.

Gubra's release calls "GUBamy (GUB014295)" an investigational long-acting amylin analogue. Six cohorts were randomized 6:2 to GUBamy or placebo. Mean body weight fell by about 3% over 6 weeks in the three highest dose groups (3.5 to 6.0 mg; 1.81 to 3.25% across timepoints) while the placebo group gained about 1% (0.52 to 1.25%). The half-life was 270 hours (11 days) with dose-proportional exposure. The most frequent adverse events were gastrointestinal and dose dependent: nausea and reduced appetite (frequent) and vomiting (occasional), mostly mild and transient. The release said the data would be presented at a future conference.

Participants / model
Healthy lean and overweight men, mean BMI 26.65
Treatment
Single subcutaneous dose
Follow-up
Body weight over 6 weeks
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

A company statement dated 13 November 2024. No peer-reviewed report was found.

Read the original source
Registry: first-in-human phase 1, UK, 76 participants, completed, no posted results

Trial registry record

ClinicalTrials.gov. NCT06144684 (sponsor AbbVie).

NCT06144684 lists the intervention as GUB014295 with the other name GUBamy, sponsored by AbbVie. It is a two-part, single-centre, randomized, placebo-controlled phase 1 in the United Kingdom with 76 participants (actual), started on 29 November 2023 and completed on 5 January 2026, with safety primary outcomes (adverse events, vital signs, laboratory safety). The registry has no posted results.

Participants / model
Lean to overweight or obese but otherwise healthy adults
Treatment
Subcutaneous single and multiple ascending doses
Follow-up
29 November 2023 to 5 January 2026
Study design
Official trial registry
Funding
not stated in the source

A registration is not an outcome, and the efficacy results on this page are company statements only.

Read the original source
Company statement, 1 April 2025: interim multiple dose part A, 7.77% loss at 2 mg on day 43

Clinical trial

Gubra. Company release dated 1 April 2025 on interim multiple ascending dose part A results for GUBamy.

In multiple ascending dose part A, the first two cohorts received 1 mg or 2 mg once weekly for 6 weeks and were followed for 6 more weeks. Least-squares mean weight change on day 43 was a 7.77% loss in the 2 mg cohort versus a 1.99% gain on placebo. Half-life was 270 hours (11 days). All related adverse events were mild, and the most frequent were dose dependent and gastrointestinal.

Participants / model
Healthy lean and overweight subjects
Treatment
Subcutaneous once weekly for 6 weeks
Follow-up
Weight on day 43
Study design
Company statement of interim phase 1 results; not peer reviewed
Funding
not stated in the source

Mean BMI was 27.63 in the placebo group and 24.33 in the 2 mg cohort, so the groups were not matched at baseline. Cohort sizes were not stated.

Read the original source
Company statement, 30 September 2026: 60 randomized, weight loss 7.8 to 9.8% at week 12, half-life 10.7 to 12.3 days

Clinical trial

Gubra. Company release dated 30 September 2026, reporting AbbVie's short oral presentation of detailed phase 1 data for ABBV-295 at EASD 2026.

The 60 participants in MAD part 2B and 2C were randomized to ABBV-295 (n = 45) or placebo (n = 15), mean age 41.5 years, mean BMI 29.3, 88% male, dosed at 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly for 12 or 13 weeks. Mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours. Least-squares mean weight loss was 7.8 to 9.8% at week 12 in the weekly cohorts, 9.7% in the every-other-week cohort and 7.9% in the monthly cohort at week 13, versus about 0.3% on placebo. Nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea by 20.0% versus 0.0%, and discontinuation for gastrointestinal events was 4.4% versus 0.0%. No serious treatment-emergent adverse events and no severe gastrointestinal events were reported. Gubra's release also says the phase 2 began in August 2026.

Participants / model
Adults, mean BMI 29.3, mostly men, 60 randomized
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
12 or 13 weeks
Study design
Company statement reporting a conference presentation of phase 1 results; not peer reviewed
Funding
not stated in the source

The EASD abstract and AbbVie's release of the same date were not retrieved, so these figures come from Gubra's release only.

Read the original source

What risks did the phase 1 reports describe?

The company reported mostly mild, dose-dependent gastrointestinal adverse events. In the most detailed report, nausea occurred in 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea in 20.0% versus 0.0%, and 4.4% versus 0.0% stopped for gastrointestinal events, with no serious treatment-emergent adverse events.

In the single dose study (13 November 2024), the most frequent adverse events were gastrointestinal and dose dependent: nausea and reduced appetite (frequent) and vomiting (occasional), mostly mild and transient. In interim multiple dose part A (1 April 2025), all related adverse events were mild, and the most frequent were dose dependent and gastrointestinal. In the 9 March 2026 release, the company said ABBV-295 was generally well tolerated, with gastrointestinal events mostly mild and mostly in the first 6 weeks.

In the 30 September 2026 report of 60 participants, nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea by 20.0% versus 0.0%, and discontinuation for gastrointestinal events was 4.4% versus 0.0%. No serious treatment-emergent adverse events and no severe gastrointestinal events were reported.

These are company statements from small phase 1 groups of mostly men. No peer-reviewed safety report exists, no phase 2 result exists, and no long-term data exist.

Company statement, 13 November 2024: single dose, weight down about 3% over 6 weeks

Clinical trial

Gubra. Company release dated 13 November 2024 on GUBamy phase 1 single ascending dose data.

Gubra's release calls "GUBamy (GUB014295)" an investigational long-acting amylin analogue. Six cohorts were randomized 6:2 to GUBamy or placebo. Mean body weight fell by about 3% over 6 weeks in the three highest dose groups (3.5 to 6.0 mg; 1.81 to 3.25% across timepoints) while the placebo group gained about 1% (0.52 to 1.25%). The half-life was 270 hours (11 days) with dose-proportional exposure. The most frequent adverse events were gastrointestinal and dose dependent: nausea and reduced appetite (frequent) and vomiting (occasional), mostly mild and transient. The release said the data would be presented at a future conference.

Participants / model
Healthy lean and overweight men, mean BMI 26.65
Treatment
Single subcutaneous dose
Follow-up
Body weight over 6 weeks
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

A company statement dated 13 November 2024. No peer-reviewed report was found.

Read the original source
Company statement, 1 April 2025: interim multiple dose part A, 7.77% loss at 2 mg on day 43

Clinical trial

Gubra. Company release dated 1 April 2025 on interim multiple ascending dose part A results for GUBamy.

In multiple ascending dose part A, the first two cohorts received 1 mg or 2 mg once weekly for 6 weeks and were followed for 6 more weeks. Least-squares mean weight change on day 43 was a 7.77% loss in the 2 mg cohort versus a 1.99% gain on placebo. Half-life was 270 hours (11 days). All related adverse events were mild, and the most frequent were dose dependent and gastrointestinal.

Participants / model
Healthy lean and overweight subjects
Treatment
Subcutaneous once weekly for 6 weeks
Follow-up
Weight on day 43
Study design
Company statement of interim phase 1 results; not peer reviewed
Funding
not stated in the source

Mean BMI was 27.63 in the placebo group and 24.33 in the 2 mg cohort, so the groups were not matched at baseline. Cohort sizes were not stated.

Read the original source
Company statement, 9 March 2026: multiple dose topline, 76 enrolled, weight loss 7.75 to 9.79% at week 12

Clinical trial

AbbVie. Company release dated 9 March 2026 on topline phase 1 multiple ascending dose results for ABBV-295.

AbbVie calls the study drug "ABBV-295 (GUB014295)" and cites NCT06144684. Doses of 2 to 14 mg were tested with different escalations and frequencies in adults with a mean BMI under 30, 88.3% male, and the release says 76 participants were enrolled in the MAD study. Least-squares mean weight change ranged from a loss of 7.75% to 9.79% at week 12 in the weekly groups (cohorts 3, 4 and 5a), a loss of 9.73% at week 13 in the every-other-week group and 7.86% at week 13 in the monthly group (monthly after week 5), versus losses of 0.26% and 0.25% on placebo at weeks 12 and 13. The release says ABBV-295 was generally well tolerated, with gastrointestinal events mostly mild and mostly in the first 6 weeks. A footnote says participants unable to continue treatment were withdrawn with no further efficacy data collected.

Participants / model
Adults with a mean BMI under 30 (healthy lean to overweight)
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
Percent change in body weight at weeks 12 and 13
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

The registry lists 76 as the enrollment for the whole two-part trial, and the release's 76 for the MAD study is not reconciled with it. Participants who could not continue were withdrawn with no further efficacy data collected.

Read the original source
Company statement, 30 September 2026: 60 randomized, weight loss 7.8 to 9.8% at week 12, half-life 10.7 to 12.3 days

Clinical trial

Gubra. Company release dated 30 September 2026, reporting AbbVie's short oral presentation of detailed phase 1 data for ABBV-295 at EASD 2026.

The 60 participants in MAD part 2B and 2C were randomized to ABBV-295 (n = 45) or placebo (n = 15), mean age 41.5 years, mean BMI 29.3, 88% male, dosed at 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly for 12 or 13 weeks. Mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours. Least-squares mean weight loss was 7.8 to 9.8% at week 12 in the weekly cohorts, 9.7% in the every-other-week cohort and 7.9% in the monthly cohort at week 13, versus about 0.3% on placebo. Nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea by 20.0% versus 0.0%, and discontinuation for gastrointestinal events was 4.4% versus 0.0%. No serious treatment-emergent adverse events and no severe gastrointestinal events were reported. Gubra's release also says the phase 2 began in August 2026.

Participants / model
Adults, mean BMI 29.3, mostly men, 60 randomized
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
12 or 13 weeks
Study design
Company statement reporting a conference presentation of phase 1 results; not peer reviewed
Funding
not stated in the source

The EASD abstract and AbbVie's release of the same date were not retrieved, so these figures come from Gubra's release only.

Read the original source

Why does GUBamy sit in C tier?

All efficacy and safety data are company-announced phase 1 results from 12 to 13 week studies, with 45 participants given ABBV-295 in the most detailed report, and none is peer reviewed. The data are thin rather than absent, and no phase 2 result exists.

The C reflects phase 1 results in healthy lean to overweight volunteers, announced by the companies and not peer reviewed, from 12 to 13 week studies with 45 participants given ABBV-295 in the most detailed report. The amylin mechanism has support from class data, such as the published phase 2 trial of petrelintide on its own page, and the company-reported weight loss is consistent across releases.

Against that, the groups were small, one baseline BMI imbalance was disclosed, and no phase 2 result exists. The data are thin rather than absent, which fits C.

Company statement, 30 September 2026: 60 randomized, weight loss 7.8 to 9.8% at week 12, half-life 10.7 to 12.3 days

Clinical trial

Gubra. Company release dated 30 September 2026, reporting AbbVie's short oral presentation of detailed phase 1 data for ABBV-295 at EASD 2026.

The 60 participants in MAD part 2B and 2C were randomized to ABBV-295 (n = 45) or placebo (n = 15), mean age 41.5 years, mean BMI 29.3, 88% male, dosed at 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly for 12 or 13 weeks. Mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours. Least-squares mean weight loss was 7.8 to 9.8% at week 12 in the weekly cohorts, 9.7% in the every-other-week cohort and 7.9% in the monthly cohort at week 13, versus about 0.3% on placebo. Nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea by 20.0% versus 0.0%, and discontinuation for gastrointestinal events was 4.4% versus 0.0%. No serious treatment-emergent adverse events and no severe gastrointestinal events were reported. Gubra's release also says the phase 2 began in August 2026.

Participants / model
Adults, mean BMI 29.3, mostly men, 60 randomized
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
12 or 13 weeks
Study design
Company statement reporting a conference presentation of phase 1 results; not peer reviewed
Funding
not stated in the source

The EASD abstract and AbbVie's release of the same date were not retrieved, so these figures come from Gubra's release only.

Read the original source
Company statement, 1 April 2025: interim multiple dose part A, 7.77% loss at 2 mg on day 43

Clinical trial

Gubra. Company release dated 1 April 2025 on interim multiple ascending dose part A results for GUBamy.

In multiple ascending dose part A, the first two cohorts received 1 mg or 2 mg once weekly for 6 weeks and were followed for 6 more weeks. Least-squares mean weight change on day 43 was a 7.77% loss in the 2 mg cohort versus a 1.99% gain on placebo. Half-life was 270 hours (11 days). All related adverse events were mild, and the most frequent were dose dependent and gastrointestinal.

Participants / model
Healthy lean and overweight subjects
Treatment
Subcutaneous once weekly for 6 weeks
Follow-up
Weight on day 43
Study design
Company statement of interim phase 1 results; not peer reviewed
Funding
not stated in the source

Mean BMI was 27.63 in the placebo group and 24.33 in the 2 mg cohort, so the groups were not matched at baseline. Cohort sizes were not stated.

Read the original source
PubMed search, 10 October 2026: one review repeating company figures, no phase 1 paper

PubMed search record

PubMed searches run on 10 October 2026 for ABBV-295, GUBamy and GUB014295, returning 1, 0 and 0 records.

The queries returned 1, 0 and 0 records. The one record is the 2026 narrative review by Alhazmi and le Roux (PMID 42452898), whose table repeats the company-reported ABBV-295 figures (about 9.8% at 12 weeks, 76 participants) and adds no independent data. No peer-reviewed paper with the phase 1 results was found.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

Read the original source
Registry: phase 2, about 360 planned, started 4 August 2026, recruiting

Trial registry record

ClinicalTrials.gov. NCT07752979 (sponsor AbbVie).

NCT07752979 is a randomized, quadruple-masked phase 2 dose-finding study of ABBV-295 in adults with obesity or overweight and a weight-related comorbidity, estimated 360 participants at about 70 sites in the United States and Puerto Rico, started on 4 August 2026, with a primary outcome of percent change in body weight at week 32 and adverse events to about week 52. It is recruiting and has no results.

Participants / model
Adults with obesity or overweight (planned)
Treatment
Subcutaneous in pre-filled syringes
Follow-up
Primary outcome at week 32 (planned)
Study design
Official trial registry
Funding
not stated in the source

A registration, not an outcome. Gubra's 30 September 2026 release also says the phase 2 began in August 2026.

Read the original source

Studies and sources

Registry: first-in-human phase 1, UK, 76 participants, completed, no posted results

Trial registry record

ClinicalTrials.gov. NCT06144684 (sponsor AbbVie).

NCT06144684 lists the intervention as GUB014295 with the other name GUBamy, sponsored by AbbVie. It is a two-part, single-centre, randomized, placebo-controlled phase 1 in the United Kingdom with 76 participants (actual), started on 29 November 2023 and completed on 5 January 2026, with safety primary outcomes (adverse events, vital signs, laboratory safety). The registry has no posted results.

Participants / model
Lean to overweight or obese but otherwise healthy adults
Treatment
Subcutaneous single and multiple ascending doses
Follow-up
29 November 2023 to 5 January 2026
Study design
Official trial registry
Funding
not stated in the source

A registration is not an outcome, and the efficacy results on this page are company statements only.

Read the original source
AbbVie 10-Q, period ended 30 June 2026: exclusive global license from Gubra

Regulatory record

AbbVie Form 10-Q for the period ended 30 June 2026. SEC EDGAR.

The filing names "GUB014295 (ABBV-295)" and dates the AbbVie and Gubra license agreement to April 2025. It says AbbVie received an exclusive global license to develop and commercialize GUB014295 (ABBV-295) for obesity. Financial terms are in the filing and are not repeated here.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Period ended 30 June 2026
Study design
Company filing
Funding
not stated in the source

AbbVie and Gubra announced the license agreement on 3 March 2025, when GUB014295 was in a phase 1 trial, and Gubra's 1 April 2025 release says all regulatory conditions were satisfied on 28 March 2025. The 10-Q's April 2025 date and the 3 March 2025 announcement date are not reconciled.

Read the original source
Company statement, 13 November 2024: single dose, weight down about 3% over 6 weeks

Clinical trial

Gubra. Company release dated 13 November 2024 on GUBamy phase 1 single ascending dose data.

Gubra's release calls "GUBamy (GUB014295)" an investigational long-acting amylin analogue. Six cohorts were randomized 6:2 to GUBamy or placebo. Mean body weight fell by about 3% over 6 weeks in the three highest dose groups (3.5 to 6.0 mg; 1.81 to 3.25% across timepoints) while the placebo group gained about 1% (0.52 to 1.25%). The half-life was 270 hours (11 days) with dose-proportional exposure. The most frequent adverse events were gastrointestinal and dose dependent: nausea and reduced appetite (frequent) and vomiting (occasional), mostly mild and transient. The release said the data would be presented at a future conference.

Participants / model
Healthy lean and overweight men, mean BMI 26.65
Treatment
Single subcutaneous dose
Follow-up
Body weight over 6 weeks
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

A company statement dated 13 November 2024. No peer-reviewed report was found.

Read the original source
Company statement, 1 April 2025: interim multiple dose part A, 7.77% loss at 2 mg on day 43

Clinical trial

Gubra. Company release dated 1 April 2025 on interim multiple ascending dose part A results for GUBamy.

In multiple ascending dose part A, the first two cohorts received 1 mg or 2 mg once weekly for 6 weeks and were followed for 6 more weeks. Least-squares mean weight change on day 43 was a 7.77% loss in the 2 mg cohort versus a 1.99% gain on placebo. Half-life was 270 hours (11 days). All related adverse events were mild, and the most frequent were dose dependent and gastrointestinal.

Participants / model
Healthy lean and overweight subjects
Treatment
Subcutaneous once weekly for 6 weeks
Follow-up
Weight on day 43
Study design
Company statement of interim phase 1 results; not peer reviewed
Funding
not stated in the source

Mean BMI was 27.63 in the placebo group and 24.33 in the 2 mg cohort, so the groups were not matched at baseline. Cohort sizes were not stated.

Read the original source
Company statement, 9 March 2026: multiple dose topline, 76 enrolled, weight loss 7.75 to 9.79% at week 12

Clinical trial

AbbVie. Company release dated 9 March 2026 on topline phase 1 multiple ascending dose results for ABBV-295.

AbbVie calls the study drug "ABBV-295 (GUB014295)" and cites NCT06144684. Doses of 2 to 14 mg were tested with different escalations and frequencies in adults with a mean BMI under 30, 88.3% male, and the release says 76 participants were enrolled in the MAD study. Least-squares mean weight change ranged from a loss of 7.75% to 9.79% at week 12 in the weekly groups (cohorts 3, 4 and 5a), a loss of 9.73% at week 13 in the every-other-week group and 7.86% at week 13 in the monthly group (monthly after week 5), versus losses of 0.26% and 0.25% on placebo at weeks 12 and 13. The release says ABBV-295 was generally well tolerated, with gastrointestinal events mostly mild and mostly in the first 6 weeks. A footnote says participants unable to continue treatment were withdrawn with no further efficacy data collected.

Participants / model
Adults with a mean BMI under 30 (healthy lean to overweight)
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
Percent change in body weight at weeks 12 and 13
Study design
Company statement of phase 1 results; not peer reviewed
Funding
not stated in the source

The registry lists 76 as the enrollment for the whole two-part trial, and the release's 76 for the MAD study is not reconciled with it. Participants who could not continue were withdrawn with no further efficacy data collected.

Read the original source
Company statement, 30 September 2026: 60 randomized, weight loss 7.8 to 9.8% at week 12, half-life 10.7 to 12.3 days

Clinical trial

Gubra. Company release dated 30 September 2026, reporting AbbVie's short oral presentation of detailed phase 1 data for ABBV-295 at EASD 2026.

The 60 participants in MAD part 2B and 2C were randomized to ABBV-295 (n = 45) or placebo (n = 15), mean age 41.5 years, mean BMI 29.3, 88% male, dosed at 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly for 12 or 13 weeks. Mean half-life ranged from 10.7 to 12.3 days and median Tmax from 24.0 to 48.1 hours. Least-squares mean weight loss was 7.8 to 9.8% at week 12 in the weekly cohorts, 9.7% in the every-other-week cohort and 7.9% in the monthly cohort at week 13, versus about 0.3% on placebo. Nausea was reported by 33.3% on ABBV-295 versus 20.0% on placebo, diarrhea by 20.0% versus 0.0%, and discontinuation for gastrointestinal events was 4.4% versus 0.0%. No serious treatment-emergent adverse events and no severe gastrointestinal events were reported. Gubra's release also says the phase 2 began in August 2026.

Participants / model
Adults, mean BMI 29.3, mostly men, 60 randomized
Treatment
Subcutaneous, weekly, every other week or monthly
Follow-up
12 or 13 weeks
Study design
Company statement reporting a conference presentation of phase 1 results; not peer reviewed
Funding
not stated in the source

The EASD abstract and AbbVie's release of the same date were not retrieved, so these figures come from Gubra's release only.

Read the original source
Registry: phase 2, about 360 planned, started 4 August 2026, recruiting

Trial registry record

ClinicalTrials.gov. NCT07752979 (sponsor AbbVie).

NCT07752979 is a randomized, quadruple-masked phase 2 dose-finding study of ABBV-295 in adults with obesity or overweight and a weight-related comorbidity, estimated 360 participants at about 70 sites in the United States and Puerto Rico, started on 4 August 2026, with a primary outcome of percent change in body weight at week 32 and adverse events to about week 52. It is recruiting and has no results.

Participants / model
Adults with obesity or overweight (planned)
Treatment
Subcutaneous in pre-filled syringes
Follow-up
Primary outcome at week 32 (planned)
Study design
Official trial registry
Funding
not stated in the source

A registration, not an outcome. Gubra's 30 September 2026 release also says the phase 2 began in August 2026.

Read the original source
Registry: three more phase 1 studies, no posted results

Trial registry record

ClinicalTrials.gov. NCT07291232, with related records NCT07414784 and NCT07514260.

Further phase 1 studies are registered with no posted results: NCT07291232 (adults with obesity, estimated 80, recruiting), NCT07414784 (women taking oral contraceptives, 20, completed) and NCT07514260 (Japanese participants with overweight or obesity, 24, active not recruiting). No interaction or ethnic-sensitivity data are public in the records reviewed.

Participants / model
Not a clinical population
Treatment
Subcutaneous
Follow-up
Not applicable
Study design
Official trial registry
Funding
not stated in the source

Registrations, not outcomes.

Read the original source
PubMed search, 10 October 2026: one review repeating company figures, no phase 1 paper

PubMed search record

PubMed searches run on 10 October 2026 for ABBV-295, GUBamy and GUB014295, returning 1, 0 and 0 records.

The queries returned 1, 0 and 0 records. The one record is the 2026 narrative review by Alhazmi and le Roux (PMID 42452898), whose table repeats the company-reported ABBV-295 figures (about 9.8% at 12 weeks, 76 participants) and adds no independent data. No peer-reviewed paper with the phase 1 results was found.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. It is not proof that no unindexed study exists.

Read the original source
FDA record search, 10 October 2026: no application or label

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA queries and DailyMed drug name searches for GUBamy, GUB014295 and ABBV-295, run on 10 October 2026.

openFDA Drugs@FDA queries for GUBamy, GUB014295 and ABBV-295 each returned "No matches found" (a control query for semaglutide returned records), and DailyMed drug name searches for the same three names returned 0 labels. The company releases state that ABBV-295 has not been approved by any health regulatory authority worldwide.

Participants / model
FDA databases, not a clinical population
Treatment
Name search
Follow-up
Queries run on 10 October 2026
Study design
Dated US approval-record search, plus company statements
Funding
not stated in the source

A search result shows what the databases returned on that date. It is US-scoped. The worldwide statement comes from the companies, not from a regulator.

Read the original source

Why is GUBamy in C tier?

C fits a compound whose efficacy and safety data are all company-announced phase 1 results from 12 to 13 week studies, with 45 participants given ABBV-295 in the most detailed report and no peer-reviewed paper. The amylin mechanism has class support and the reported weight loss is consistent across releases, but the groups were small, one baseline imbalance was disclosed, and no phase 2 result exists.