Pemvidutide

updated

Pemvidutide (ALT-801) is an unapproved once-weekly injectable GLP-1 and glucagon dual receptor agonist from Altimmune. In IMPACT, a peer-reviewed 24-week phase 2b trial in 212 adults with biopsy-confirmed MASH, MASH resolution without worsening of fibrosis occurred in 58% on 1.2 mg and 52% on 1.8 mg versus 20% on placebo, while the fibrosis endpoint was not met. A phase 3 trial began enrolling in July to August 2026 and has no data, and the weight-loss results are company statements only.

GLP-1 and glucagon receptor dual agonist peptide

  • Pemvidutide has the development code ALT-801 and is sponsored by Altimmune, Inc. PubChem has no compound record matching the name, and vendor-submitted records disagree on formula, so no formula or molecular weight is given.
  • In IMPACT (212 adults with biopsy-confirmed MASH, F2 or F3, 24 weeks), MASH resolution without worsening of fibrosis occurred in 58% at 1.2 mg and 52% at 1.8 mg versus 20% on placebo (p<0.0001). Fibrosis improvement was 33% and 36% versus 28% (p=0.59 and p=0.27).
  • In a 12-week study of 94 adults with liver fat of at least 10%, relative liver fat reductions were 46.6%, 68.5% and 57.1% versus 4.4% on placebo.
  • The company reported on 30 November 2023 that in MOMENTUM (391 adults, 48 weeks) weight change was -10.3%, -11.2% and -15.6% versus -2.2% on placebo, with 19.2% and 19.6% discontinuing for adverse events at 1.8 and 2.4 mg. No peer-reviewed report exists.
  • NCT07795164, a phase 3 trial in noncirrhotic MASH (estimated 1800 adults), has a registry start of 30 July 2026, and the company said on 3 August 2026 that enrollment had begun. It has no results.
  • An openFDA Drugs@FDA search and a DailyMed search on 10 October 2026 found no FDA application record and no label. No human pharmacokinetic study has been reported in the sources reviewed.

What is pemvidutide, and is it approved anywhere?

Pemvidutide (code ALT-801) is a once-weekly injectable GLP-1 and glucagon dual receptor agonist from Altimmune. It is not approved: no FDA application record or label turned up on 10 October 2026, and no approval appears in any source reviewed. No formula or molecular weight is established.

The registry record NCT04972396 is titled with the code ALT-801, its summary calls the compound pemvidutide (ALT-801), and its sponsor is Altimmune, Inc. Altimmune is also the sponsor of the other registry records read for this page. The Lancet IMPACT abstract describes pemvidutide as a GLP-1/glucagon dual receptor agonist given once weekly by subcutaneous injection.

PubChem has no compound record that matches the name. A compound name search returns no CID, and a substance name search returns vendor-submitted records whose formulas disagree. No formula, molecular weight or CAS number is given here until Altimmune or a WHO INN record supplies one, and WHO INN status was not confirmed from a WHO record.

On 10 October 2026 an openFDA Drugs@FDA search by generic name returned no application records, and a DailyMed search returned 0 labels. No approval appears in any source reviewed.

Registry: code ALT-801, sponsor Altimmune; no PubChem compound record

Trial registry record

ClinicalTrials.gov record NCT04972396, read on 10 October 2026, with PubChem name searches run the same day.

The registry record NCT04972396 is titled with the code ALT-801, its summary calls the compound pemvidutide (ALT-801), and its sponsor is Altimmune, Inc., which is also the sponsor on the other registry records read (NCT05006885, NCT05295875, NCT05989711, NCT07795164). The Lancet IMPACT abstract describes it as a GLP-1/glucagon dual receptor agonist given once weekly by subcutaneous injection. PubChem has no compound record that matches the name: a compound name search returns no CID, and a substance name search returns vendor-submitted records whose formulas disagree. No formula or molecular weight is given on this page until Altimmune or a WHO INN record supplies one. WHO INN status was not confirmed from a WHO record.

Participants / model
Chemical identity, not a clinical population
Treatment
Subcutaneous peptide injection
Follow-up
Not applicable
Study design
Trial registry record, with PubChem compound and substance name searches
Funding
not stated in the source

NCT04972396 is also a registered drug interaction study (40 completed participants) with no posted results. The code ALT-801 maps to the name pemvidutide through the registry summary.

Read the original source
US and registry searches, 10 October 2026: no label, 8 registry records

Regulatory record

DailyMed, U.S. National Library of Medicine, search for pemvidutide; openFDA Drugs@FDA search by generic name; ClinicalTrials.gov query pemvidutide. All run on 10 October 2026.

An openFDA Drugs@FDA search by generic name pemvidutide returned no application records, and a DailyMed search for pemvidutide returned 0 labels. No FDA approval or label exists in those sources. ClinicalTrials.gov returned 8 records for the query pemvidutide (4 phase 1, 3 phase 2, 1 phase 3). Phase 2 studies in alcohol use disorder (RECLAIM, NCT06987513, completed, n=100) and alcohol-associated liver disease (RESTORE, NCT07009860, active) are registrations without posted results.

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

A search result shows what the databases held on that date. Registrations are not outcomes.

Read the original source

What did the phase 2b study in MASH find?

In IMPACT, 212 adults with biopsy-confirmed MASH (F2 or F3) had MASH resolution without worsening of fibrosis at 24 weeks in 58% on 1.2 mg and 52% on 1.8 mg versus 20% on placebo. Fibrosis improvement did not differ significantly from placebo, and the authors state the fibrosis endpoint was not met.

IMPACT (NCT05989711) was a randomized phase 2b trial funded by Altimmune and published in the Lancet. It randomized 212 patients from 83 sites in the USA and Australia 1:2:2 to weekly subcutaneous pemvidutide 1.2 mg, 1.8 mg (both without dose titration) or placebo. The patients were adults with biopsy-confirmed MASH, fibrosis stage F2 or F3.

At 24 weeks, MASH resolution without worsening of fibrosis occurred in 18 (20%) of 86 on placebo, 24 (58%) of 41 at 1.2 mg (difference 38% [95% CI 21 to 56]; p<0.0001) and 45 (52%) of 85 at 1.8 mg (difference 32% [95% CI 19 to 46]; p<0.0001). Fibrosis improvement without worsening of MASH occurred in 24 (28%) of 86 on placebo, 13 (33%) of 41 at 1.2 mg (difference 5% [95% CI -13 to 22]; p=0.59) and 30 (36%) of 85 at 1.8 mg (difference 8% [95% CI -6 to 22]; p=0.27). The authors state the trial met the MASH resolution endpoint and did not meet the fibrosis endpoint at 24 weeks.

IMPACT phase 2b: 212 adults with MASH F2 or F3, 24 weeks, histology and safety

Randomized controlled trial

Noureddin M et al. Lancet. 2025;406(10520):2644-2655. PMID 41237796.

At 24 weeks, MASH resolution without worsening of fibrosis occurred in 18 (20%) of 86 on placebo, 24 (58%) of 41 at 1.2 mg (difference 38% [95% CI 21 to 56]; p<0.0001), and 45 (52%) of 85 at 1.8 mg (difference 32% [95% CI 19 to 46]; p<0.0001). Fibrosis improvement without worsening of MASH occurred in 24 (28%) of 86 on placebo, 13 (33%) of 41 at 1.2 mg (difference 5% [95% CI -13 to 22]; p=0.59), and 30 (36%) of 85 at 1.8 mg (difference 8% [95% CI -6 to 22]; p=0.27). The authors state the trial met the MASH resolution endpoint and did not meet the fibrosis endpoint at 24 weeks. Adverse events were reported in 32 (78%) of 41 patients at 1.2 mg, 69 (81%) of 85 at 1.8 mg, and 58 (67%) of 86 on placebo, mostly mild or moderate. Discontinuations due to adverse events were none of 41 at 1.2 mg, one (1%) of 85 at 1.8 mg, and two (2%) of 86 on placebo.

Participants / model
212 adults with biopsy-confirmed MASH, fibrosis stage F2 or F3, from 83 sites in the USA and Australia
Treatment
Pemvidutide 1.2 mg or 1.8 mg subcutaneously once weekly, both without dose titration, or placebo, randomized 1:2:2
Follow-up
24 weeks
Study design
Randomized phase 2b trial (NCT05989711)
Funding
Funded by Altimmune

The abstract does not name the most common adverse events, so no event-specific rates are given on this page.

Read the original source

What did the earlier liver fat studies find?

In a 12-week randomized study of 94 adults with liver fat of at least 10%, liver fat fell by 46.6%, 68.5% and 57.1% at 1.2, 1.8 and 2.4 mg versus 4.4% on placebo. A 24-week extension in 64 participants gave reductions of 56.3%, 75.2% and 76.4% versus 14.0%.

The 12-week study (NCT05006885) randomized 94 patients with BMI of at least 28 and liver fat of at least 10% by MRI-PDFF (median baseline BMI 36.2 kg/m2, liver fat 20.6%, 29% with type 2 diabetes) to pemvidutide 1.2, 1.8 or 2.4 mg or placebo, subcutaneously once weekly. Relative reductions in liver fat at week 12 were 46.6%, 68.5% and 57.1% versus 4.4% for placebo (p<0.001 for each dose). The maximal weight loss was -4.3% (p<0.001) at 1.8 mg. No severe or serious adverse events were reported.

A double-blind 12-week extension (NCT05292911) included 64 participants who continued their assigned dose for 24 weeks in total. Relative reductions in liver fat at 24 weeks were 56.3%, 75.2% and 76.4% for 1.2, 1.8 and 2.4 mg versus 14.0% for placebo (p<0.001 for each dose). Body weight was reduced by 6.2% (p<0.001 versus placebo) over 24 weeks, and the abstract does not say which dose group that figure belongs to. The authors describe low incidences of side effects.

Liver fat by MRI-PDFF is an imaging endpoint, not a biopsy result.

12-week MASLD study: 94 adults, liver fat down 46.6% to 68.5% versus 4.4%

Randomized controlled trial

Harrison SA et al. J Hepatol. 2025;82(1):7-17. PMID 39002641.

Relative reductions in liver fat at week 12 were 46.6%, 68.5% and 57.1% for the three doses (1.2, 1.8 and 2.4 mg) versus 4.4% for placebo (p<0.001 for each dose). The maximal weight loss was -4.3% (p<0.001) at 1.8 mg. No severe or serious adverse events were reported.

Participants / model
94 patients with BMI of at least 28 and liver fat of at least 10% by MRI-PDFF (median baseline BMI 36.2 kg/m2, liver fat 20.6%, 29% with type 2 diabetes)
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly, or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled study (NCT05006885)
Funding
not stated in the source

Liver fat by MRI-PDFF is an imaging endpoint, not a biopsy result.

Read the original source
24-week extension: 64 adults, liver fat down 56.3% to 76.4% versus 14.0%

Randomized controlled trial

Browne SK et al. JHEP Rep. 2025;7(11):101483. PMID 41113119.

Relative reductions in liver fat at 24 weeks were 56.3%, 75.2% and 76.4% for 1.2, 1.8 and 2.4 mg versus 14.0% for placebo (p<0.001 for each dose). Body weight was reduced by 6.2% (p<0.001 versus placebo) over 24 weeks; the abstract does not say which dose group that figure belongs to. The authors describe low incidences of side effects.

Participants / model
64 adults with MASLD who completed the 12-week study
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly for 24 weeks in total
Follow-up
24 weeks
Study design
Randomized double-blind 12-week extension (NCT05292911) of the 12-week study
Funding
not stated in the source

The 6.2% weight reduction is not assigned to a dose group in the abstract.

Read the original source

What has the company reported that the papers do not show?

Two sets of results come only from company statements: 48-week non-invasive markers from IMPACT (reported 19 December 2025) and the 48-week MOMENTUM obesity trial in 391 adults (reported 30 November 2023), with weight change of -10.3% to -15.6% versus -2.2% on placebo. Neither is peer reviewed.

On 19 December 2025 the company reported 48-week non-invasive results from the same 212-patient IMPACT trial. The enhanced liver fibrosis (ELF) score mean change was -0.49 (1.2 mg) and -0.58 (1.8 mg) versus +0.16 on placebo, and liver stiffness change was -3.04 kPa and -3.97 kPa versus -0.03 kPa on placebo. A combined liver-stiffness and ELF responder definition was met by 27.8% and 32.4% versus 3.2% on placebo. Weight loss was 4.5% and 7.5% versus 0.2% on placebo, and adverse events leading to discontinuation were 0% and 1.2% versus 3.5%. The release reports no 48-week biopsy percentages, because the histology primary endpoints were measured at 24 weeks.

On 30 November 2023 the company reported MOMENTUM, a 48-week phase 2 obesity trial (NCT05295875, completed, no results posted in the registry) that randomized 391 adults with obesity or overweight plus at least one comorbidity and without diabetes 1:1:1:1 to pemvidutide 1.2, 1.8 or 2.4 mg weekly or placebo. Mean weight change at week 48 was -10.3%, -11.2% and -15.6% versus -2.2% on placebo (all p<0.001). These are mean changes from baseline as reported.

No peer-reviewed MOMENTUM report was found in a PubMed search on 10 October 2026. The obesity efficacy figures rest on the company statement.

Company statement, 19 December 2025: 48-week non-invasive IMPACT data, not peer reviewed

Regulatory record

Altimmune Form 8-K press release, 19 December 2025, read from a filing mirror (Boardroom Alpha).

The company reported 48-week non-invasive results from the same 212-patient trial. Enhanced liver fibrosis (ELF) score mean change was -0.49 (1.2 mg) and -0.58 (1.8 mg) versus +0.16 on placebo; liver stiffness change was -3.04 kPa and -3.97 kPa versus -0.03 kPa on placebo; 27.8% and 32.4% of patients met a combined liver-stiffness and ELF responder definition versus 3.2% on placebo; weight loss was 4.5% and 7.5% versus 0.2% on placebo; adverse events leading to discontinuation were 0% and 1.2% versus 3.5% on placebo. The release reports no 48-week biopsy percentages: the histology primary endpoints were measured at 24 weeks.

Participants / model
Same 212 adults with MASH F2 to F3
Treatment
Pemvidutide 1.2 mg or 1.8 mg subcutaneously once weekly for 48 weeks
Follow-up
48 weeks
Study design
Company press release filed as an SEC 8-K; not peer reviewed
Funding
not stated in the source

The 48-week figures are non-invasive markers, not biopsy results.

Read the original source
Company statement, 30 November 2023: MOMENTUM obesity data, not peer reviewed

Regulatory record

Altimmune press release, SEC exhibit 99.1, 30 November 2023, on sec.gov.

MOMENTUM, a 48-week phase 2 obesity trial registered as NCT05295875 (completed, no results posted), randomized 391 adults with obesity or overweight plus at least one comorbidity and without diabetes 1:1:1:1 to pemvidutide 1.2, 1.8 or 2.4 mg weekly or placebo. Mean weight change at week 48 was -10.3%, -11.2% and -15.6% versus -2.2% on placebo (all p<0.001). Adverse events leading to discontinuation were 6 (6.2%) on placebo, 5 (5.1%) at 1.2 mg, 19 (19.2%) at 1.8 mg and 19 (19.6%) at 2.4 mg. The release says nausea and vomiting made up most adverse events, one subject had a drug-related serious adverse event (vomiting at 2.4 mg), and there were no major adverse cardiac events. No peer-reviewed MOMENTUM report was found.

Participants / model
391 adults with obesity or overweight, no diabetes
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly, or placebo
Follow-up
48 weeks
Study design
Company press release filed as an SEC exhibit; not peer reviewed
Funding
not stated in the source

The company has described heart-rate effects in MOMENTUM as not clinically meaningful, with no peer-reviewed source.

Read the original source
PubMed search, 10 October 2026: 13 records, none on MOMENTUM or pharmacokinetics

PubMed search record

PubMed search for pemvidutide, run on 10 October 2026.

A PubMed search for pemvidutide returned 13 records. By title and journal, three are pemvidutide trial reports (J Hepatol 2025, JHEP Rep 2025, Lancet 2025), one is a Lancet comment on IMPACT, and the rest are reviews, meta-analyses, or a registry review. None reports the MOMENTUM obesity trial and none reports a human pharmacokinetic study. The registered drug-interaction study (NCT04972396, 40 completed participants) has no posted results. Obesity efficacy and pharmacokinetics therefore rest on company statements or are unavailable.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Search run on 10 October 2026
Study design
Dated 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 report exists.

Read the original source

Has the phase 3 trial started, and does it have results?

It has started and has no results. NCT07795164 is registered as recruiting from 30 July 2026 (estimated 1800 adults with noncirrhotic MASH), and the company said on 3 August 2026 that PERFORMA had begun enrolling, with a 52-week readout anticipated in 2029.

NCT07795164 is a phase 3, multinational, randomized, double-blind, placebo-controlled study in adults aged 18 to 75 with noncirrhotic MASH (F2 or F3), with two cohorts, estimated enrollment 1800, registry start 30 July 2026, status Recruiting and last update 23 September 2026. The primary outcomes listed are MASH resolution and fibrosis improvement through week 52 and a clinical outcome event through about month 60. The sponsor is Altimmune.

On 3 August 2026 the company said it had begun enrolling patients in PERFORMA. Cohort 1 will enroll approximately 990 patients and is designed to support accelerated approval on a biopsy-assessed endpoint at 52 weeks. Cohort 2 will enroll approximately 800 patients with fibrosis identified by non-invasive tests to expand the safety database. The release reports enrollment beginning, not a first-dose date, and contains no data.

ClinicalTrials.gov returned 8 records for pemvidutide on 10 October 2026 (4 phase 1, 3 phase 2, 1 phase 3). Phase 2 studies in alcohol use disorder (RECLAIM, NCT06987513, completed, 100 participants) and alcohol-associated liver disease (RESTORE, NCT07009860, active) have no posted results. A registration is not an outcome.

Registry: phase 3 in MASH, 1800 estimated, recruiting since 30 July 2026, no results

Trial registry record

ClinicalTrials.gov record NCT07795164, read on 10 October 2026.

NCT07795164 is a phase 3, multinational, randomized, double-blind, placebo-controlled study of pemvidutide in adults aged 18 to 75 with noncirrhotic MASH (F2 or F3), with two cohorts, estimated enrollment 1800, registry start date 2026-07-30, status Recruiting, last update 2026-09-23. Primary outcomes listed are MASH resolution and fibrosis improvement through week 52 and a clinical outcome event through about month 60. Sponsor Altimmune, Inc. This is a registration, not a result: no phase 3 efficacy or safety data exist.

Participants / model
Adults with noncirrhotic MASH, planned
Treatment
Pemvidutide subcutaneous injection versus placebo
Follow-up
Primary outcomes through week 52 and through about month 60
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Enrollment is an estimate.

Read the original source
Company statement, 3 August 2026: PERFORMA enrollment begun, no data

Regulatory record

Altimmune press release, 3 August 2026, on BioSpace.

Altimmune says it has begun enrolling patients in PERFORMA, a global phase 3 trial of pemvidutide in MASH with moderate to advanced fibrosis (F2 to F3). Cohort 1 will enroll approximately 990 patients and is designed to support accelerated approval on a biopsy-assessed endpoint of MASH resolution and/or fibrosis improvement at 52 weeks; cohort 2 will enroll approximately 800 patients with fibrosis identified by non-invasive tests to expand the safety database. The company anticipates the 52-week readout in 2029. The release reports enrollment beginning, not a first-dose date, and contains no trial data.

Participants / model
Adults with MASH and F2 to F3 fibrosis, planned
Treatment
Pemvidutide subcutaneous injection versus placebo
Follow-up
52-week readout anticipated in 2029
Study design
Company press release on a phase 3 start; not peer reviewed
Funding
not stated in the source

The release gives no efficacy or safety data.

Read the original source
US and registry searches, 10 October 2026: no label, 8 registry records

Regulatory record

DailyMed, U.S. National Library of Medicine, search for pemvidutide; openFDA Drugs@FDA search by generic name; ClinicalTrials.gov query pemvidutide. All run on 10 October 2026.

An openFDA Drugs@FDA search by generic name pemvidutide returned no application records, and a DailyMed search for pemvidutide returned 0 labels. No FDA approval or label exists in those sources. ClinicalTrials.gov returned 8 records for the query pemvidutide (4 phase 1, 3 phase 2, 1 phase 3). Phase 2 studies in alcohol use disorder (RECLAIM, NCT06987513, completed, n=100) and alcohol-associated liver disease (RESTORE, NCT07009860, active) are registrations without posted results.

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

A search result shows what the databases held on that date. Registrations are not outcomes.

Read the original source

Has a phase 3 trial of pemvidutide just started in MASH?

Yes. The registry lists the phase 3 study from 30 July 2026 as recruiting, and the company announced on 3 August 2026 that enrollment had begun. It carries no efficacy or safety data.

Sellers describe pemvidutide as a GLP-1 and glucagon receptor dual agonist from Altimmune with a phase 3 trial that has just started in MASH.

The claim is correct. The registry start date for NCT07795164 is 30 July 2026, and Altimmune announced on 3 August 2026 that it had begun enrolling patients in PERFORMA. The 52-week readout is anticipated in 2029, so the phase 3 has produced no data. The peer-reviewed MASH evidence is the 24-week phase 2b trial IMPACT.

Registry: phase 3 in MASH, 1800 estimated, recruiting since 30 July 2026, no results

Trial registry record

ClinicalTrials.gov record NCT07795164, read on 10 October 2026.

NCT07795164 is a phase 3, multinational, randomized, double-blind, placebo-controlled study of pemvidutide in adults aged 18 to 75 with noncirrhotic MASH (F2 or F3), with two cohorts, estimated enrollment 1800, registry start date 2026-07-30, status Recruiting, last update 2026-09-23. Primary outcomes listed are MASH resolution and fibrosis improvement through week 52 and a clinical outcome event through about month 60. Sponsor Altimmune, Inc. This is a registration, not a result: no phase 3 efficacy or safety data exist.

Participants / model
Adults with noncirrhotic MASH, planned
Treatment
Pemvidutide subcutaneous injection versus placebo
Follow-up
Primary outcomes through week 52 and through about month 60
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Enrollment is an estimate.

Read the original source
Company statement, 3 August 2026: PERFORMA enrollment begun, no data

Regulatory record

Altimmune press release, 3 August 2026, on BioSpace.

Altimmune says it has begun enrolling patients in PERFORMA, a global phase 3 trial of pemvidutide in MASH with moderate to advanced fibrosis (F2 to F3). Cohort 1 will enroll approximately 990 patients and is designed to support accelerated approval on a biopsy-assessed endpoint of MASH resolution and/or fibrosis improvement at 52 weeks; cohort 2 will enroll approximately 800 patients with fibrosis identified by non-invasive tests to expand the safety database. The company anticipates the 52-week readout in 2029. The release reports enrollment beginning, not a first-dose date, and contains no trial data.

Participants / model
Adults with MASH and F2 to F3 fibrosis, planned
Treatment
Pemvidutide subcutaneous injection versus placebo
Follow-up
52-week readout anticipated in 2029
Study design
Company press release on a phase 3 start; not peer reviewed
Funding
not stated in the source

The release gives no efficacy or safety data.

Read the original source

How does pemvidutide work, and what is known about its exposure?

Pemvidutide is a GLP-1 and glucagon dual receptor agonist given once weekly by subcutaneous injection. In a 12-week study it reduced liver fat by 46.6% to 68.5% versus 4.4% on placebo. No human pharmacokinetic study has been reported in the sources reviewed.

The Lancet IMPACT abstract describes pemvidutide as a GLP-1/glucagon dual receptor agonist given once weekly by subcutaneous injection. The sources reviewed give no receptor pharmacology data beyond that description.

Its effects in people are the liver fat reductions (46.6% to 68.5% versus 4.4% on placebo at 12 weeks), the MASH resolution signal at 24 weeks and weight loss of 4.3% at 12 weeks in the peer-reviewed studies. A PubMed search on 10 October 2026 returned 13 records and none reports a human pharmacokinetic study. The registered drug interaction study (NCT04972396, 40 completed participants) has no posted results, so half-life and Tmax are not established.

Registry: code ALT-801, sponsor Altimmune; no PubChem compound record

Trial registry record

ClinicalTrials.gov record NCT04972396, read on 10 October 2026, with PubChem name searches run the same day.

The registry record NCT04972396 is titled with the code ALT-801, its summary calls the compound pemvidutide (ALT-801), and its sponsor is Altimmune, Inc., which is also the sponsor on the other registry records read (NCT05006885, NCT05295875, NCT05989711, NCT07795164). The Lancet IMPACT abstract describes it as a GLP-1/glucagon dual receptor agonist given once weekly by subcutaneous injection. PubChem has no compound record that matches the name: a compound name search returns no CID, and a substance name search returns vendor-submitted records whose formulas disagree. No formula or molecular weight is given on this page until Altimmune or a WHO INN record supplies one. WHO INN status was not confirmed from a WHO record.

Participants / model
Chemical identity, not a clinical population
Treatment
Subcutaneous peptide injection
Follow-up
Not applicable
Study design
Trial registry record, with PubChem compound and substance name searches
Funding
not stated in the source

NCT04972396 is also a registered drug interaction study (40 completed participants) with no posted results. The code ALT-801 maps to the name pemvidutide through the registry summary.

Read the original source
12-week MASLD study: 94 adults, liver fat down 46.6% to 68.5% versus 4.4%

Randomized controlled trial

Harrison SA et al. J Hepatol. 2025;82(1):7-17. PMID 39002641.

Relative reductions in liver fat at week 12 were 46.6%, 68.5% and 57.1% for the three doses (1.2, 1.8 and 2.4 mg) versus 4.4% for placebo (p<0.001 for each dose). The maximal weight loss was -4.3% (p<0.001) at 1.8 mg. No severe or serious adverse events were reported.

Participants / model
94 patients with BMI of at least 28 and liver fat of at least 10% by MRI-PDFF (median baseline BMI 36.2 kg/m2, liver fat 20.6%, 29% with type 2 diabetes)
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly, or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled study (NCT05006885)
Funding
not stated in the source

Liver fat by MRI-PDFF is an imaging endpoint, not a biopsy result.

Read the original source
PubMed search, 10 October 2026: 13 records, none on MOMENTUM or pharmacokinetics

PubMed search record

PubMed search for pemvidutide, run on 10 October 2026.

A PubMed search for pemvidutide returned 13 records. By title and journal, three are pemvidutide trial reports (J Hepatol 2025, JHEP Rep 2025, Lancet 2025), one is a Lancet comment on IMPACT, and the rest are reviews, meta-analyses, or a registry review. None reports the MOMENTUM obesity trial and none reports a human pharmacokinetic study. The registered drug-interaction study (NCT04972396, 40 completed participants) has no posted results. Obesity efficacy and pharmacokinetics therefore rest on company statements or are unavailable.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Search run on 10 October 2026
Study design
Dated 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 report exists.

Read the original source

What adverse effects have been reported?

In IMPACT, adverse events were reported in 78% at 1.2 mg, 81% at 1.8 mg and 67% on placebo, mostly mild or moderate, with discontinuations of 0%, 1% and 2%. In MOMENTUM, as the company reported on 30 November 2023, adverse events led to discontinuation in 19.2% and 19.6% at 1.8 and 2.4 mg versus 6.2% on placebo, and nausea and vomiting made up most adverse events.

In IMPACT at 24 weeks, adverse events were reported in 32 (78%) of 41 patients at 1.2 mg, 69 (81%) of 85 at 1.8 mg and 58 (67%) of 86 on placebo, mostly mild or moderate. Discontinuations due to adverse events were none of 41 at 1.2 mg, one (1%) of 85 at 1.8 mg and two (2%) of 86 on placebo. The abstract does not name the most common events. In the 12-week liver fat study, no severe or serious adverse events were reported.

In MOMENTUM, the company reported on 30 November 2023 adverse events leading to discontinuation in 6 (6.2%) on placebo, 5 (5.1%) at 1.2 mg, 19 (19.2%) at 1.8 mg and 19 (19.6%) at 2.4 mg. The release says nausea and vomiting made up most adverse events, one participant had a drug-related serious adverse event (vomiting at 2.4 mg) and there were no major adverse cardiac events. The company has described heart-rate effects in MOMENTUM as not clinically meaningful, with no peer-reviewed source. In the 48-week IMPACT statement, adverse events led to discontinuation in 0% and 1.2% versus 3.5% on placebo. These company figures are not peer reviewed.

No serious safety signal appears in the sources reviewed. No phase 3 safety data exist yet, and human pharmacokinetics and interactions are not reported.

IMPACT phase 2b: 212 adults with MASH F2 or F3, 24 weeks, histology and safety

Randomized controlled trial

Noureddin M et al. Lancet. 2025;406(10520):2644-2655. PMID 41237796.

At 24 weeks, MASH resolution without worsening of fibrosis occurred in 18 (20%) of 86 on placebo, 24 (58%) of 41 at 1.2 mg (difference 38% [95% CI 21 to 56]; p<0.0001), and 45 (52%) of 85 at 1.8 mg (difference 32% [95% CI 19 to 46]; p<0.0001). Fibrosis improvement without worsening of MASH occurred in 24 (28%) of 86 on placebo, 13 (33%) of 41 at 1.2 mg (difference 5% [95% CI -13 to 22]; p=0.59), and 30 (36%) of 85 at 1.8 mg (difference 8% [95% CI -6 to 22]; p=0.27). The authors state the trial met the MASH resolution endpoint and did not meet the fibrosis endpoint at 24 weeks. Adverse events were reported in 32 (78%) of 41 patients at 1.2 mg, 69 (81%) of 85 at 1.8 mg, and 58 (67%) of 86 on placebo, mostly mild or moderate. Discontinuations due to adverse events were none of 41 at 1.2 mg, one (1%) of 85 at 1.8 mg, and two (2%) of 86 on placebo.

Participants / model
212 adults with biopsy-confirmed MASH, fibrosis stage F2 or F3, from 83 sites in the USA and Australia
Treatment
Pemvidutide 1.2 mg or 1.8 mg subcutaneously once weekly, both without dose titration, or placebo, randomized 1:2:2
Follow-up
24 weeks
Study design
Randomized phase 2b trial (NCT05989711)
Funding
Funded by Altimmune

The abstract does not name the most common adverse events, so no event-specific rates are given on this page.

Read the original source
12-week MASLD study: 94 adults, liver fat down 46.6% to 68.5% versus 4.4%

Randomized controlled trial

Harrison SA et al. J Hepatol. 2025;82(1):7-17. PMID 39002641.

Relative reductions in liver fat at week 12 were 46.6%, 68.5% and 57.1% for the three doses (1.2, 1.8 and 2.4 mg) versus 4.4% for placebo (p<0.001 for each dose). The maximal weight loss was -4.3% (p<0.001) at 1.8 mg. No severe or serious adverse events were reported.

Participants / model
94 patients with BMI of at least 28 and liver fat of at least 10% by MRI-PDFF (median baseline BMI 36.2 kg/m2, liver fat 20.6%, 29% with type 2 diabetes)
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly, or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled study (NCT05006885)
Funding
not stated in the source

Liver fat by MRI-PDFF is an imaging endpoint, not a biopsy result.

Read the original source
Company statement, 30 November 2023: MOMENTUM obesity data, not peer reviewed

Regulatory record

Altimmune press release, SEC exhibit 99.1, 30 November 2023, on sec.gov.

MOMENTUM, a 48-week phase 2 obesity trial registered as NCT05295875 (completed, no results posted), randomized 391 adults with obesity or overweight plus at least one comorbidity and without diabetes 1:1:1:1 to pemvidutide 1.2, 1.8 or 2.4 mg weekly or placebo. Mean weight change at week 48 was -10.3%, -11.2% and -15.6% versus -2.2% on placebo (all p<0.001). Adverse events leading to discontinuation were 6 (6.2%) on placebo, 5 (5.1%) at 1.2 mg, 19 (19.2%) at 1.8 mg and 19 (19.6%) at 2.4 mg. The release says nausea and vomiting made up most adverse events, one subject had a drug-related serious adverse event (vomiting at 2.4 mg), and there were no major adverse cardiac events. No peer-reviewed MOMENTUM report was found.

Participants / model
391 adults with obesity or overweight, no diabetes
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly, or placebo
Follow-up
48 weeks
Study design
Company press release filed as an SEC exhibit; not peer reviewed
Funding
not stated in the source

The company has described heart-rate effects in MOMENTUM as not clinically meaningful, with no peer-reviewed source.

Read the original source
Company statement, 19 December 2025: 48-week non-invasive IMPACT data, not peer reviewed

Regulatory record

Altimmune Form 8-K press release, 19 December 2025, read from a filing mirror (Boardroom Alpha).

The company reported 48-week non-invasive results from the same 212-patient trial. Enhanced liver fibrosis (ELF) score mean change was -0.49 (1.2 mg) and -0.58 (1.8 mg) versus +0.16 on placebo; liver stiffness change was -3.04 kPa and -3.97 kPa versus -0.03 kPa on placebo; 27.8% and 32.4% of patients met a combined liver-stiffness and ELF responder definition versus 3.2% on placebo; weight loss was 4.5% and 7.5% versus 0.2% on placebo; adverse events leading to discontinuation were 0% and 1.2% versus 3.5% on placebo. The release reports no 48-week biopsy percentages: the histology primary endpoints were measured at 24 weeks.

Participants / model
Same 212 adults with MASH F2 to F3
Treatment
Pemvidutide 1.2 mg or 1.8 mg subcutaneously once weekly for 48 weeks
Follow-up
48 weeks
Study design
Company press release filed as an SEC 8-K; not peer reviewed
Funding
not stated in the source

The 48-week figures are non-invasive markers, not biopsy results.

Read the original source

Why does pemvidutide sit in B tier?

B reflects a large MASH resolution signal and dose-dependent liver fat reductions in peer-reviewed phase 2 work, but the fibrosis endpoint was not met, the 48-week data are non-invasive and company-reported, and high-dose discontinuation for adverse events ran near 19 to 20% in the obesity trial the company reported on 30 November 2023. The phase 3 has no data yet.

B fits a compound with a randomized phase 2b trial in a top journal (212 patients) that met one of its two co-primary histology endpoints at 24 weeks and missed the other, a weight-loss phase 2 that exists only as a company statement, and a phase 3 that began enrolling in July to August 2026 with no data.

The MASH resolution signal was large and the liver fat effect was dose-dependent, but the fibrosis endpoint was not met, the 48-week data are non-invasive and company-reported, and high-dose discontinuation for adverse events ran near 19 to 20% in the obesity trial the company reported on 30 November 2023. It sits below the site's survodutide and mazdutide grades because it has no completed phase 3. No serious safety signal appears in the sources reviewed.

IMPACT phase 2b: 212 adults with MASH F2 or F3, 24 weeks, histology and safety

Randomized controlled trial

Noureddin M et al. Lancet. 2025;406(10520):2644-2655. PMID 41237796.

At 24 weeks, MASH resolution without worsening of fibrosis occurred in 18 (20%) of 86 on placebo, 24 (58%) of 41 at 1.2 mg (difference 38% [95% CI 21 to 56]; p<0.0001), and 45 (52%) of 85 at 1.8 mg (difference 32% [95% CI 19 to 46]; p<0.0001). Fibrosis improvement without worsening of MASH occurred in 24 (28%) of 86 on placebo, 13 (33%) of 41 at 1.2 mg (difference 5% [95% CI -13 to 22]; p=0.59), and 30 (36%) of 85 at 1.8 mg (difference 8% [95% CI -6 to 22]; p=0.27). The authors state the trial met the MASH resolution endpoint and did not meet the fibrosis endpoint at 24 weeks. Adverse events were reported in 32 (78%) of 41 patients at 1.2 mg, 69 (81%) of 85 at 1.8 mg, and 58 (67%) of 86 on placebo, mostly mild or moderate. Discontinuations due to adverse events were none of 41 at 1.2 mg, one (1%) of 85 at 1.8 mg, and two (2%) of 86 on placebo.

Participants / model
212 adults with biopsy-confirmed MASH, fibrosis stage F2 or F3, from 83 sites in the USA and Australia
Treatment
Pemvidutide 1.2 mg or 1.8 mg subcutaneously once weekly, both without dose titration, or placebo, randomized 1:2:2
Follow-up
24 weeks
Study design
Randomized phase 2b trial (NCT05989711)
Funding
Funded by Altimmune

The abstract does not name the most common adverse events, so no event-specific rates are given on this page.

Read the original source
Company statement, 30 November 2023: MOMENTUM obesity data, not peer reviewed

Regulatory record

Altimmune press release, SEC exhibit 99.1, 30 November 2023, on sec.gov.

MOMENTUM, a 48-week phase 2 obesity trial registered as NCT05295875 (completed, no results posted), randomized 391 adults with obesity or overweight plus at least one comorbidity and without diabetes 1:1:1:1 to pemvidutide 1.2, 1.8 or 2.4 mg weekly or placebo. Mean weight change at week 48 was -10.3%, -11.2% and -15.6% versus -2.2% on placebo (all p<0.001). Adverse events leading to discontinuation were 6 (6.2%) on placebo, 5 (5.1%) at 1.2 mg, 19 (19.2%) at 1.8 mg and 19 (19.6%) at 2.4 mg. The release says nausea and vomiting made up most adverse events, one subject had a drug-related serious adverse event (vomiting at 2.4 mg), and there were no major adverse cardiac events. No peer-reviewed MOMENTUM report was found.

Participants / model
391 adults with obesity or overweight, no diabetes
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly, or placebo
Follow-up
48 weeks
Study design
Company press release filed as an SEC exhibit; not peer reviewed
Funding
not stated in the source

The company has described heart-rate effects in MOMENTUM as not clinically meaningful, with no peer-reviewed source.

Read the original source
Company statement, 19 December 2025: 48-week non-invasive IMPACT data, not peer reviewed

Regulatory record

Altimmune Form 8-K press release, 19 December 2025, read from a filing mirror (Boardroom Alpha).

The company reported 48-week non-invasive results from the same 212-patient trial. Enhanced liver fibrosis (ELF) score mean change was -0.49 (1.2 mg) and -0.58 (1.8 mg) versus +0.16 on placebo; liver stiffness change was -3.04 kPa and -3.97 kPa versus -0.03 kPa on placebo; 27.8% and 32.4% of patients met a combined liver-stiffness and ELF responder definition versus 3.2% on placebo; weight loss was 4.5% and 7.5% versus 0.2% on placebo; adverse events leading to discontinuation were 0% and 1.2% versus 3.5% on placebo. The release reports no 48-week biopsy percentages: the histology primary endpoints were measured at 24 weeks.

Participants / model
Same 212 adults with MASH F2 to F3
Treatment
Pemvidutide 1.2 mg or 1.8 mg subcutaneously once weekly for 48 weeks
Follow-up
48 weeks
Study design
Company press release filed as an SEC 8-K; not peer reviewed
Funding
not stated in the source

The 48-week figures are non-invasive markers, not biopsy results.

Read the original source
Registry: phase 3 in MASH, 1800 estimated, recruiting since 30 July 2026, no results

Trial registry record

ClinicalTrials.gov record NCT07795164, read on 10 October 2026.

NCT07795164 is a phase 3, multinational, randomized, double-blind, placebo-controlled study of pemvidutide in adults aged 18 to 75 with noncirrhotic MASH (F2 or F3), with two cohorts, estimated enrollment 1800, registry start date 2026-07-30, status Recruiting, last update 2026-09-23. Primary outcomes listed are MASH resolution and fibrosis improvement through week 52 and a clinical outcome event through about month 60. Sponsor Altimmune, Inc. This is a registration, not a result: no phase 3 efficacy or safety data exist.

Participants / model
Adults with noncirrhotic MASH, planned
Treatment
Pemvidutide subcutaneous injection versus placebo
Follow-up
Primary outcomes through week 52 and through about month 60
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Enrollment is an estimate.

Read the original source
Company statement, 3 August 2026: PERFORMA enrollment begun, no data

Regulatory record

Altimmune press release, 3 August 2026, on BioSpace.

Altimmune says it has begun enrolling patients in PERFORMA, a global phase 3 trial of pemvidutide in MASH with moderate to advanced fibrosis (F2 to F3). Cohort 1 will enroll approximately 990 patients and is designed to support accelerated approval on a biopsy-assessed endpoint of MASH resolution and/or fibrosis improvement at 52 weeks; cohort 2 will enroll approximately 800 patients with fibrosis identified by non-invasive tests to expand the safety database. The company anticipates the 52-week readout in 2029. The release reports enrollment beginning, not a first-dose date, and contains no trial data.

Participants / model
Adults with MASH and F2 to F3 fibrosis, planned
Treatment
Pemvidutide subcutaneous injection versus placebo
Follow-up
52-week readout anticipated in 2029
Study design
Company press release on a phase 3 start; not peer reviewed
Funding
not stated in the source

The release gives no efficacy or safety data.

Read the original source

Studies and sources

Registry: code ALT-801, sponsor Altimmune; no PubChem compound record

Trial registry record

ClinicalTrials.gov record NCT04972396, read on 10 October 2026, with PubChem name searches run the same day.

The registry record NCT04972396 is titled with the code ALT-801, its summary calls the compound pemvidutide (ALT-801), and its sponsor is Altimmune, Inc., which is also the sponsor on the other registry records read (NCT05006885, NCT05295875, NCT05989711, NCT07795164). The Lancet IMPACT abstract describes it as a GLP-1/glucagon dual receptor agonist given once weekly by subcutaneous injection. PubChem has no compound record that matches the name: a compound name search returns no CID, and a substance name search returns vendor-submitted records whose formulas disagree. No formula or molecular weight is given on this page until Altimmune or a WHO INN record supplies one. WHO INN status was not confirmed from a WHO record.

Participants / model
Chemical identity, not a clinical population
Treatment
Subcutaneous peptide injection
Follow-up
Not applicable
Study design
Trial registry record, with PubChem compound and substance name searches
Funding
not stated in the source

NCT04972396 is also a registered drug interaction study (40 completed participants) with no posted results. The code ALT-801 maps to the name pemvidutide through the registry summary.

Read the original source
Registry: phase 3 in MASH, 1800 estimated, recruiting since 30 July 2026, no results

Trial registry record

ClinicalTrials.gov record NCT07795164, read on 10 October 2026.

NCT07795164 is a phase 3, multinational, randomized, double-blind, placebo-controlled study of pemvidutide in adults aged 18 to 75 with noncirrhotic MASH (F2 or F3), with two cohorts, estimated enrollment 1800, registry start date 2026-07-30, status Recruiting, last update 2026-09-23. Primary outcomes listed are MASH resolution and fibrosis improvement through week 52 and a clinical outcome event through about month 60. Sponsor Altimmune, Inc. This is a registration, not a result: no phase 3 efficacy or safety data exist.

Participants / model
Adults with noncirrhotic MASH, planned
Treatment
Pemvidutide subcutaneous injection versus placebo
Follow-up
Primary outcomes through week 52 and through about month 60
Study design
Trial registry record; no posted results
Funding
not stated in the source

A registration describes a plan, not a result. Enrollment is an estimate.

Read the original source
Company statement, 3 August 2026: PERFORMA enrollment begun, no data

Regulatory record

Altimmune press release, 3 August 2026, on BioSpace.

Altimmune says it has begun enrolling patients in PERFORMA, a global phase 3 trial of pemvidutide in MASH with moderate to advanced fibrosis (F2 to F3). Cohort 1 will enroll approximately 990 patients and is designed to support accelerated approval on a biopsy-assessed endpoint of MASH resolution and/or fibrosis improvement at 52 weeks; cohort 2 will enroll approximately 800 patients with fibrosis identified by non-invasive tests to expand the safety database. The company anticipates the 52-week readout in 2029. The release reports enrollment beginning, not a first-dose date, and contains no trial data.

Participants / model
Adults with MASH and F2 to F3 fibrosis, planned
Treatment
Pemvidutide subcutaneous injection versus placebo
Follow-up
52-week readout anticipated in 2029
Study design
Company press release on a phase 3 start; not peer reviewed
Funding
not stated in the source

The release gives no efficacy or safety data.

Read the original source
IMPACT phase 2b: 212 adults with MASH F2 or F3, 24 weeks, histology and safety

Randomized controlled trial

Noureddin M et al. Lancet. 2025;406(10520):2644-2655. PMID 41237796.

At 24 weeks, MASH resolution without worsening of fibrosis occurred in 18 (20%) of 86 on placebo, 24 (58%) of 41 at 1.2 mg (difference 38% [95% CI 21 to 56]; p<0.0001), and 45 (52%) of 85 at 1.8 mg (difference 32% [95% CI 19 to 46]; p<0.0001). Fibrosis improvement without worsening of MASH occurred in 24 (28%) of 86 on placebo, 13 (33%) of 41 at 1.2 mg (difference 5% [95% CI -13 to 22]; p=0.59), and 30 (36%) of 85 at 1.8 mg (difference 8% [95% CI -6 to 22]; p=0.27). The authors state the trial met the MASH resolution endpoint and did not meet the fibrosis endpoint at 24 weeks. Adverse events were reported in 32 (78%) of 41 patients at 1.2 mg, 69 (81%) of 85 at 1.8 mg, and 58 (67%) of 86 on placebo, mostly mild or moderate. Discontinuations due to adverse events were none of 41 at 1.2 mg, one (1%) of 85 at 1.8 mg, and two (2%) of 86 on placebo.

Participants / model
212 adults with biopsy-confirmed MASH, fibrosis stage F2 or F3, from 83 sites in the USA and Australia
Treatment
Pemvidutide 1.2 mg or 1.8 mg subcutaneously once weekly, both without dose titration, or placebo, randomized 1:2:2
Follow-up
24 weeks
Study design
Randomized phase 2b trial (NCT05989711)
Funding
Funded by Altimmune

The abstract does not name the most common adverse events, so no event-specific rates are given on this page.

Read the original source
Company statement, 19 December 2025: 48-week non-invasive IMPACT data, not peer reviewed

Regulatory record

Altimmune Form 8-K press release, 19 December 2025, read from a filing mirror (Boardroom Alpha).

The company reported 48-week non-invasive results from the same 212-patient trial. Enhanced liver fibrosis (ELF) score mean change was -0.49 (1.2 mg) and -0.58 (1.8 mg) versus +0.16 on placebo; liver stiffness change was -3.04 kPa and -3.97 kPa versus -0.03 kPa on placebo; 27.8% and 32.4% of patients met a combined liver-stiffness and ELF responder definition versus 3.2% on placebo; weight loss was 4.5% and 7.5% versus 0.2% on placebo; adverse events leading to discontinuation were 0% and 1.2% versus 3.5% on placebo. The release reports no 48-week biopsy percentages: the histology primary endpoints were measured at 24 weeks.

Participants / model
Same 212 adults with MASH F2 to F3
Treatment
Pemvidutide 1.2 mg or 1.8 mg subcutaneously once weekly for 48 weeks
Follow-up
48 weeks
Study design
Company press release filed as an SEC 8-K; not peer reviewed
Funding
not stated in the source

The 48-week figures are non-invasive markers, not biopsy results.

Read the original source
12-week MASLD study: 94 adults, liver fat down 46.6% to 68.5% versus 4.4%

Randomized controlled trial

Harrison SA et al. J Hepatol. 2025;82(1):7-17. PMID 39002641.

Relative reductions in liver fat at week 12 were 46.6%, 68.5% and 57.1% for the three doses (1.2, 1.8 and 2.4 mg) versus 4.4% for placebo (p<0.001 for each dose). The maximal weight loss was -4.3% (p<0.001) at 1.8 mg. No severe or serious adverse events were reported.

Participants / model
94 patients with BMI of at least 28 and liver fat of at least 10% by MRI-PDFF (median baseline BMI 36.2 kg/m2, liver fat 20.6%, 29% with type 2 diabetes)
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly, or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled study (NCT05006885)
Funding
not stated in the source

Liver fat by MRI-PDFF is an imaging endpoint, not a biopsy result.

Read the original source
24-week extension: 64 adults, liver fat down 56.3% to 76.4% versus 14.0%

Randomized controlled trial

Browne SK et al. JHEP Rep. 2025;7(11):101483. PMID 41113119.

Relative reductions in liver fat at 24 weeks were 56.3%, 75.2% and 76.4% for 1.2, 1.8 and 2.4 mg versus 14.0% for placebo (p<0.001 for each dose). Body weight was reduced by 6.2% (p<0.001 versus placebo) over 24 weeks; the abstract does not say which dose group that figure belongs to. The authors describe low incidences of side effects.

Participants / model
64 adults with MASLD who completed the 12-week study
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly for 24 weeks in total
Follow-up
24 weeks
Study design
Randomized double-blind 12-week extension (NCT05292911) of the 12-week study
Funding
not stated in the source

The 6.2% weight reduction is not assigned to a dose group in the abstract.

Read the original source
Company statement, 30 November 2023: MOMENTUM obesity data, not peer reviewed

Regulatory record

Altimmune press release, SEC exhibit 99.1, 30 November 2023, on sec.gov.

MOMENTUM, a 48-week phase 2 obesity trial registered as NCT05295875 (completed, no results posted), randomized 391 adults with obesity or overweight plus at least one comorbidity and without diabetes 1:1:1:1 to pemvidutide 1.2, 1.8 or 2.4 mg weekly or placebo. Mean weight change at week 48 was -10.3%, -11.2% and -15.6% versus -2.2% on placebo (all p<0.001). Adverse events leading to discontinuation were 6 (6.2%) on placebo, 5 (5.1%) at 1.2 mg, 19 (19.2%) at 1.8 mg and 19 (19.6%) at 2.4 mg. The release says nausea and vomiting made up most adverse events, one subject had a drug-related serious adverse event (vomiting at 2.4 mg), and there were no major adverse cardiac events. No peer-reviewed MOMENTUM report was found.

Participants / model
391 adults with obesity or overweight, no diabetes
Treatment
Pemvidutide 1.2, 1.8 or 2.4 mg subcutaneously once weekly, or placebo
Follow-up
48 weeks
Study design
Company press release filed as an SEC exhibit; not peer reviewed
Funding
not stated in the source

The company has described heart-rate effects in MOMENTUM as not clinically meaningful, with no peer-reviewed source.

Read the original source
PubMed search, 10 October 2026: 13 records, none on MOMENTUM or pharmacokinetics

PubMed search record

PubMed search for pemvidutide, run on 10 October 2026.

A PubMed search for pemvidutide returned 13 records. By title and journal, three are pemvidutide trial reports (J Hepatol 2025, JHEP Rep 2025, Lancet 2025), one is a Lancet comment on IMPACT, and the rest are reviews, meta-analyses, or a registry review. None reports the MOMENTUM obesity trial and none reports a human pharmacokinetic study. The registered drug-interaction study (NCT04972396, 40 completed participants) has no posted results. Obesity efficacy and pharmacokinetics therefore rest on company statements or are unavailable.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Search run on 10 October 2026
Study design
Dated 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 report exists.

Read the original source

Why is Pemvidutide in B tier?

B fits a compound with a randomized phase 2b trial in a top journal that met one histology endpoint and missed the other, a weight-loss phase 2 that exists only as a company statement, and a phase 3 that began enrolling in July to August 2026. It sits below the site's survodutide and mazdutide grades because it has no completed phase 3, and the fibrosis endpoint was not met.