Efinopegdutide

updated

Efinopegdutide (MK-6024) is an unapproved once-weekly GLP-1 and glucagon receptor dual agonist that Merck licensed from Hanmi in 2020. Published data are an open-label phase IIa liver-fat study and two 2021 phase 2 trials under the earlier code JNJ-64565111. The 381-patient phase 2b MASH trial is registered as completed with no results posted or published, so the claim that phase 2b MASH data are in is not supported.

GLP-1 and glucagon receptor dual agonist

  • Efinopegdutide has the codes MK-6024, HM12525A and JNJ-64565111, tied together by the registry. PubChem has no compound record, so no formula or CAS number is available.
  • In an open-label phase IIa trial of 145 adults with NAFLD, efinopegdutide 10 mg lowered liver fat by 72.7% versus 42.3% with semaglutide 1 mg over 24 weeks (p<0.001), and body weight fell 8.5% versus 7.1% (p=0.085).
  • Under the code JNJ-64565111, a 474-adult phase 2 trial in obesity gave placebo-subtracted weight changes of -6.8%, -8.1% and -10.0% at week 26 versus -5.8% for liraglutide. In 195 adults with type 2 diabetes and obesity, HbA1c did not change at any dose.
  • The phase 2b MASH trial NCT05877547 is registered as Completed with 381 enrolled and primary completion on 29 December 2025. No results are posted, and PubMed searches on 10 October 2026 found no report.
  • Merck's public pipeline chart as of 5 August 2026 lists efinopegdutide under Phase 2 for MASH, and no phase 3 study is registered.
  • An openFDA Drugs@FDA search and a DailyMed search on 10 October 2026 found no FDA application record and no label.

What is efinopegdutide, and is it approved anywhere?

Efinopegdutide (MK-6024, formerly HM12525A and JNJ-64565111) is a once-weekly GLP-1 and glucagon receptor dual agonist that Merck licensed from Hanmi in 2020. It is not approved: no FDA application record or label turned up on 10 October 2026, and PubChem has no compound record, so no formula or CAS number is established.

The ClinicalTrials.gov record NCT05877547 lists the intervention efinopegdutide with the other names MK-6024, HM12525A and JNJ-64565111, and its sponsor is Merck Sharp & Dohme LLC. The same three names appear on Merck's other efinopegdutide records. Janssen R&D authors published the 2021 phase 2 reports under the code JNJ-64565111, which the registry equates with the Merck molecule.

PubChem has no compound record (CID) for efinopegdutide, MK-6024, HM12525A or JNJ-64565111. Depositor-submitted substance records exist for efinopegdutide, HM12525A and JNJ-64565111, but they link to no compound, and none exists for MK-6024. No formula or CAS number is given here, because none is available from an official chemical record.

In a statement dated 4 August 2020, Merck announced an exclusive license from Hanmi Pharmaceutical to develop, manufacture and commercialize efinopegdutide in the United States and globally, with Hanmi retaining an option to commercialize in Korea. The release calls efinopegdutide, formerly HM12525A, Hanmi's investigational once-weekly GLP-1/glucagon receptor dual agonist. It gives no numbers.

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: codes MK-6024, HM12525A and JNJ-64565111; no PubChem compound record

Trial registry record

ClinicalTrials.gov record NCT05877547, read on 10 October 2026, with PubChem name searches run the same day.

The ClinicalTrials.gov record NCT05877547 lists the intervention efinopegdutide with other names MK-6024, HM12525A and JNJ-64565111, and its sponsor is Merck Sharp & Dohme LLC. The same three names appear on Merck's other efinopegdutide records (NCT04944992, NCT06482112, NCT06052566). Janssen R&D authors published the 2021 phase 2 reports under the code JNJ-64565111, which the registry equates with the Merck molecule. PubChem has no compound record (CID) for efinopegdutide, MK-6024, HM12525A or JNJ-64565111. Depositor-submitted substance records exist for efinopegdutide, HM12525A and JNJ-64565111 (three substance IDs carry all three names) but link to no compound, and none exists for MK-6024, so no formula or CAS number is available from an official chemical record.

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

The three codes are tied to one molecule by the registry, not by a chemical record. Substance IDs 381128243, 404719341 and 472419764 link to no compound.

Read the original source
Company statement, 4 August 2020: Merck license from Hanmi

Regulatory record

Merck press release, 4 August 2020, on merck.com.

Merck announced an exclusive license from Hanmi Pharmaceutical to develop, manufacture and commercialize efinopegdutide in the United States and globally, with Hanmi retaining an option to commercialize in Korea. The release calls efinopegdutide, formerly HM12525A, Hanmi's investigational once-weekly GLP-1/glucagon receptor dual agonist. It says efficacy and safety were evaluated in multiple phase 1 and phase 2 trials, including in severely obese people with and without type 2 diabetes, and gives no numbers.

Participants / model
Not a clinical population
Treatment
License agreement
Follow-up
Statement dated 4 August 2020
Study design
Company press release on a license agreement; not peer reviewed
Funding
not stated in the source

The release gives no trial numbers. Milestone terms and earlier rights history are not established here and are not stated on this page.

Read the original source
US searches, 10 October 2026: no application records and no labels

Regulatory record

DailyMed, U.S. National Library of Medicine, search for efinopegdutide; openFDA Drugs@FDA search by generic name. Both run on 10 October 2026.

An openFDA Drugs@FDA search by generic name efinopegdutide returned no application records, and a DailyMed search for efinopegdutide returned 0 labels. No FDA approval or label exists in those sources.

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

A search result shows what the databases held on that date.

Read the original source

What did the published liver fat study find?

In an open-label phase IIa trial of 145 adults with NAFLD, efinopegdutide 10 mg lowered liver fat by 72.7% versus 42.3% with semaglutide 1 mg over 24 weeks (p<0.001), and body weight fell 8.5% versus 7.1% (p=0.085). The comparator was the 1 mg diabetes dose, and the endpoint was an imaging measure.

The trial (NCT04944992) randomized 145 adults with NAFLD and liver fat of at least 10% (mean BMI 34.3 kg/m2, mean liver fat 20.3%, 33.1% with type 2 diabetes) to efinopegdutide 10 mg (n=72) or semaglutide 1 mg (n=73), each subcutaneously once weekly, for 24 weeks. It was open-label.

The least-squares mean relative reduction in liver fat was 72.7% (90% CI 66.8 to 78.7) with efinopegdutide versus 42.3% (90% CI 36.5 to 48.1) with semaglutide, p<0.001. Body weight fell 8.5% versus 7.1% (p=0.085). The comparator was the 1 mg diabetes dose of semaglutide, not the 2.4 mg obesity dose. Liver fat was measured by MRI-PDFF, an imaging endpoint, not a biopsy.

Phase IIa: 145 adults with NAFLD, 24 weeks, liver fat down 72.7% versus 42.3% on semaglutide 1 mg

Randomized controlled trial

Romero-Gómez M et al. J Hepatol. 2023;79(4):888-897. PMID 37355043.

Efinopegdutide 10 mg once weekly (n=72) lowered liver fat more than semaglutide 1 mg once weekly (n=73) over 24 weeks: least-squares mean relative reduction 72.7% (90% CI 66.8 to 78.7) versus 42.3% (90% CI 36.5 to 48.1), p<0.001. Body weight fell 8.5% versus 7.1% (p=0.085). Adverse events and drug-related adverse events were slightly more frequent with efinopegdutide, mainly gastrointestinal.

Participants / model
145 adults with NAFLD and liver fat of at least 10% (mean BMI 34.3 kg/m2, mean liver fat 20.3%, 33.1% with type 2 diabetes)
Treatment
Efinopegdutide 10 mg or semaglutide 1 mg subcutaneously once weekly
Follow-up
24 weeks
Study design
Randomized open-label phase IIa trial (NCT04944992)
Funding
not stated in the source

Open-label, with an imaging endpoint (MRI-PDFF). The comparator was the 1 mg diabetes dose of semaglutide, not the 2.4 mg obesity dose.

Read the original source

What did the 2021 phase 2 trials in obesity and type 2 diabetes find?

Under the earlier code JNJ-64565111, 474 adults with obesity lost a placebo-subtracted 6.8%, 8.1% and 10.0% of body weight at week 26 on three doses, versus 5.8% for liraglutide. In 195 adults with type 2 diabetes and obesity, weight fell but HbA1c did not change at any dose.

In the obesity trial, 474 adults with class II or III obesity (BMI 35 to 50) and without type 2 diabetes were randomized 1:1:2:2:2 to placebo, JNJ-64565111 at 5.0, 7.4 or 10.0 mg (no dose escalation), or open-label liraglutide 3.0 mg. At week 26, placebo-subtracted body weight changes were -6.8%, -8.1% and -10.0% for the three doses and -5.8% for liraglutide. 343 (72.4%) completed treatment.

In the diabetes trial, a 12-week randomized double-blind phase 2 study dosed 195 adults with type 2 diabetes (HbA1c 6.5 to 9.5%) and class II or III obesity. Placebo-subtracted body weight changes were -4.6%, -5.9% and -7.2% at 5.0, 7.4 and 10.0 mg. All doses were associated with no change in HbA1c, a slight numerical rise in fasting insulin, and numerical increases in fasting plasma glucose at 5.0 and 7.4 mg. 144 (73.8%) completed treatment.

Both trials were published under the Janssen code JNJ-64565111, which the registry equates with efinopegdutide.

2021 phase 2 under code JNJ-64565111: 474 adults with obesity, week 26, placebo-subtracted -6.8% to -10.0%

Randomized controlled trial

Alba M et al. Clin Obes. 2021;11(2):e12432. PMID 33475255.

At week 26, placebo-subtracted body weight changes were -6.8%, -8.1% and -10.0% for the three doses (5.0, 7.4 and 10.0 mg) and -5.8% for liraglutide; 343 (72.4%) completed treatment. Treatment-emergent adverse events, especially nausea and vomiting, were more frequent on each dose than on placebo or liraglutide.

Participants / model
474 adults with class II or III obesity (BMI 35 to 50) and without type 2 diabetes
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously (no dose escalation), placebo, or open-label liraglutide 3.0 mg, randomized 1:1:2:2:2
Follow-up
26 weeks
Study design
Randomized phase 2 trial under the Janssen code, with an open-label liraglutide arm
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111, which the registry equates with efinopegdutide.

Read the original source
2021 phase 2 under code JNJ-64565111: 195 adults with type 2 diabetes and obesity, no HbA1c change

Randomized controlled trial

Di Prospero NA et al. Clin Obes. 2021;11(2):e12433. PMID 33475251.

Placebo-subtracted body weight changes were -4.6%, -5.9% and -7.2% at 5.0, 7.4 and 10.0 mg. All doses were associated with no change in HbA1c, a slight numerical rise in fasting insulin, and numerical increases in fasting plasma glucose at 5.0 and 7.4 mg. Adverse events, especially nausea and vomiting, were more frequent than on placebo. 144 (73.8%) completed treatment.

Participants / model
195 adults with type 2 diabetes (HbA1c 6.5 to 9.5%) and class II or III obesity
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously, or placebo
Follow-up
12 weeks
Study design
Randomized double-blind phase 2 trial under the Janssen code
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111. The abstract reports weight loss without HbA1c lowering.

Read the original source

What do the registry-posted results add?

Two registry records have posted results that are not peer reviewed. An open-label phase 2a study in 124 adults with MASLD showed liver fat reductions of 42.1% to 67.8% at week 28, and a hepatic impairment study in 22 adults gave a geometric mean half-life of 115 to 149 hours after a single dose.

NCT06482112 is an open-label phase 2a study with no placebo arm in 124 adults with MASLD, comparing efinopegdutide 10 mg weekly (n=42), 10 mg every 2 weeks (n=40) and 15 mg every 2 weeks (n=42). Mean relative reduction in liver fat at week 28 was 67.8% (90% CI 60.7 to 74.9), 54.4% (46.8 to 61.9) and 42.1% (34.6 to 49.5), and body weight change was -7.5%, -3.9% and -4.1%. Any adverse event occurred in 83.3%, 82.1% and 85.7%, and discontinuation due to an adverse event was 7.1%, 5.1% and 9.5%.

NCT06052566 gave a single 7 mg subcutaneous dose to 8 adults with moderate and 8 with severe hepatic impairment and 6 matched healthy participants. Geometric mean AUC0-inf was 143, 152 and 146 hr*ug/mL, and the geometric mean ratio versus healthy participants was 0.97 (95% CI 0.61 to 1.54) for moderate and 1.04 (0.63 to 1.71) for severe impairment. Geometric mean apparent terminal half-life was 146, 149 and 115 hours, and median Tmax was 120.00, 72.04 and 83.78 hours, listed for moderate impairment, severe impairment and healthy participants in that order.

These are registry-posted results, not peer-reviewed publications.

Registry-posted results: 124 adults with MASLD, 28 weeks, no placebo arm, not peer reviewed

Trial registry record

ClinicalTrials.gov record NCT06482112, posted results read on 10 October 2026.

NCT06482112 is an open-label phase 2a study with no placebo arm in 124 adults with MASLD comparing efinopegdutide 10 mg weekly (n=42), 10 mg every 2 weeks (n=40) and 15 mg every 2 weeks (n=42). Mean relative reduction in liver fat at week 28 was 67.8% (90% CI 60.7 to 74.9), 54.4% (46.8 to 61.9) and 42.1% (34.6 to 49.5); body weight change was -7.5%, -3.9% and -4.1%. Any adverse event occurred in 83.3%, 82.1% and 85.7%; discontinuation due to an adverse event was 7.1%, 5.1% and 9.5%.

Participants / model
124 adults with MASLD
Treatment
Efinopegdutide subcutaneous, weekly or every 2 weeks, for 28 weeks
Follow-up
28 weeks
Study design
Trial registry posted results; open-label with no placebo arm; not peer reviewed
Funding
not stated in the source

Registry-posted results are not a peer-reviewed publication.

Read the original source
Registry-posted pharmacokinetics: 22 adults, single subcutaneous dose, half-life 115 to 149 hours

Trial registry record

ClinicalTrials.gov record NCT06052566, posted results read on 10 October 2026.

A single 7 mg subcutaneous dose was given to 8 adults with moderate and 8 with severe hepatic impairment and 6 matched healthy participants. Geometric mean AUC0-inf was 143, 152 and 146 hr*ug/mL; the geometric mean ratio versus healthy participants was 0.97 (95% CI 0.61 to 1.54) for moderate and 1.04 (0.63 to 1.71) for severe impairment. Geometric mean apparent terminal half-life was 146, 149 and 115 hours. Median Tmax was 120.00, 72.04 and 83.78 hours.

Participants / model
22 adults: moderate hepatic impairment, severe hepatic impairment, and matched healthy controls
Treatment
Efinopegdutide 7 mg subcutaneous, single dose
Follow-up
Single dose
Study design
Trial registry posted results; not peer reviewed
Funding
not stated in the source

Values are listed for moderate impairment, severe impairment and healthy participants in that order. Registry-posted results are not a peer-reviewed publication, so no single half-life is entered in the structured fields.

Read the original source

Where are the phase 2b MASH results?

Not public in any source reviewed. The 381-patient phase 2b MASH trial (NCT05877547) is registered as Completed with primary completion on 29 December 2025 and no posted results. PubMed searches on 10 October 2026 found no report, and Merck's pipeline chart still lists the compound at phase 2 with no phase 3 registered.

NCT05877547 is a phase 2b randomized, double-blind, placebo-controlled study in adults with precirrhotic NASH. The listed interventions are efinopegdutide, semaglutide and placebo, and the primary outcome is NASH resolution without worsening of fibrosis at week 52. The registry lists it as Completed, with 381 enrolled (actual), primary completion on 29 December 2025, last update on 12 January 2026 and results not posted.

A PubMed search on 10 October 2026 for efinopegdutide returned 9 records, and a search adding steatohepatitis, MASH, NASH or phase 2b returned 5. None reports NCT05877547, and web searches the same day found no Merck results announcement. Whether Merck has presented the results at a congress is not established, since the searches found none, which does not prove none exist. A completed study with no posted data is not an outcome.

Merck's public pipeline chart as of 5 August 2026 lists efinopegdutide (MK-6024) under Phase 2 for MASH, as did the chart dated 30 April 2026. The ClinicalTrials.gov query efinopegdutide returned 7 records on 10 October 2026, 3 phase 1 and 4 phase 2, and none is a phase 3 study.

Searches, 10 October 2026: phase 2b NCT05877547 completed, no results posted or published

PubMed search record

PubMed searches for efinopegdutide and for efinopegdutide AND (steatohepatitis OR MASH OR NASH OR phase 2b), run on 10 October 2026, with ClinicalTrials.gov record NCT05877547.

The phase 2b MASH trial is registered but has no posted or published results. NCT05877547 is a phase 2b randomized, double-blind, placebo-controlled study in adults with precirrhotic NASH (efinopegdutide, semaglutide and placebo are the listed interventions; primary outcome NASH resolution without worsening of fibrosis at week 52). The registry lists it as Completed, enrollment 381 (actual), primary completion 2025-12-29, last update 2026-01-12, results not posted. A PubMed search run 2026-10-10 for efinopegdutide returned 9 records, and a search adding steatohepatitis, MASH, NASH or phase 2b returned 5, none of which reports NCT05877547. Web searches run the same day found no Merck results announcement. The claim that phase 2b data are in is not supported by any record reviewed.

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

A completed study with no posted data is not an outcome. Whether Merck has presented the results at a congress is not established; the searches found none, which does not prove none exist.

Read the original source
Company pipeline chart as of 5 August 2026: phase 2 for MASH; no phase 3 registered

Regulatory record

Merck public pipeline chart as of 5 August 2026 (and the chart dated 30 April 2026), on merck.com; ClinicalTrials.gov query efinopegdutide, run on 10 October 2026.

Merck's public pipeline chart as of 2026-08-05 lists efinopegdutide (MK-6024) under Phase 2 for MASH, as did the chart dated 2026-04-30. The ClinicalTrials.gov query efinopegdutide returned 7 records on 2026-10-10, 3 phase 1 and 4 phase 2; none is a phase 3 study.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Chart dated 5 August 2026; registry query run on 10 October 2026
Study design
Company pipeline chart and registry search
Funding
not stated in the source

A pipeline chart is a company statement of development stage, not a regulator record.

Read the original source

Is efinopegdutide licensed by Merck from Hanmi, and are its phase 2b MASH data in?

The license is supported by Merck's 2020 statement. The claim that phase 2b MASH data are in is not supported: the trial is registered as completed, but no result has been posted, presented in a source reviewed, or published.

Sellers describe efinopegdutide as a GLP-1 and glucagon receptor dual agonist, licensed by Merck from Hanmi, whose phase 2b MASH data are in.

The license part holds: Merck announced an exclusive license from Hanmi on 4 August 2020. The data part does not. The phase 2b MASH trial NCT05877547 finished with primary completion on 29 December 2025, and no registry results, publication or Merck results announcement was found on 10 October 2026. The published efinopegdutide data are an open-label phase IIa liver-fat study and two 2021 phase 2 trials under the older Janssen code, plus registry-posted phase 2a results.

Company statement, 4 August 2020: Merck license from Hanmi

Regulatory record

Merck press release, 4 August 2020, on merck.com.

Merck announced an exclusive license from Hanmi Pharmaceutical to develop, manufacture and commercialize efinopegdutide in the United States and globally, with Hanmi retaining an option to commercialize in Korea. The release calls efinopegdutide, formerly HM12525A, Hanmi's investigational once-weekly GLP-1/glucagon receptor dual agonist. It says efficacy and safety were evaluated in multiple phase 1 and phase 2 trials, including in severely obese people with and without type 2 diabetes, and gives no numbers.

Participants / model
Not a clinical population
Treatment
License agreement
Follow-up
Statement dated 4 August 2020
Study design
Company press release on a license agreement; not peer reviewed
Funding
not stated in the source

The release gives no trial numbers. Milestone terms and earlier rights history are not established here and are not stated on this page.

Read the original source
Searches, 10 October 2026: phase 2b NCT05877547 completed, no results posted or published

PubMed search record

PubMed searches for efinopegdutide and for efinopegdutide AND (steatohepatitis OR MASH OR NASH OR phase 2b), run on 10 October 2026, with ClinicalTrials.gov record NCT05877547.

The phase 2b MASH trial is registered but has no posted or published results. NCT05877547 is a phase 2b randomized, double-blind, placebo-controlled study in adults with precirrhotic NASH (efinopegdutide, semaglutide and placebo are the listed interventions; primary outcome NASH resolution without worsening of fibrosis at week 52). The registry lists it as Completed, enrollment 381 (actual), primary completion 2025-12-29, last update 2026-01-12, results not posted. A PubMed search run 2026-10-10 for efinopegdutide returned 9 records, and a search adding steatohepatitis, MASH, NASH or phase 2b returned 5, none of which reports NCT05877547. Web searches run the same day found no Merck results announcement. The claim that phase 2b data are in is not supported by any record reviewed.

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

A completed study with no posted data is not an outcome. Whether Merck has presented the results at a congress is not established; the searches found none, which does not prove none exist.

Read the original source

How does efinopegdutide work, and how long does it stay in the body?

Merck describes it as an investigational once-weekly GLP-1 and glucagon receptor dual agonist. In a registry-posted study, the geometric mean apparent terminal half-life after a single 7 mg subcutaneous dose was 115 to 149 hours across groups.

Merck's 2020 release calls efinopegdutide Hanmi's investigational once-weekly GLP-1/glucagon receptor dual agonist. The sources reviewed give no receptor pharmacology data beyond that description.

In people, the published effects are liver fat reduction, weight loss and, in type 2 diabetes with obesity, no change in HbA1c. In the registry-posted hepatic impairment study, geometric mean apparent terminal half-life was 146, 149 and 115 hours after a single 7 mg subcutaneous dose in moderate impairment, severe impairment and healthy participants, and median Tmax was 120.00, 72.04 and 83.78 hours. These are registry-posted values, not peer-reviewed ones, and the geometric mean AUC0-inf ratios versus healthy participants were 0.97 (95% CI 0.61 to 1.54) for moderate and 1.04 (0.63 to 1.71) for severe impairment.

Company statement, 4 August 2020: Merck license from Hanmi

Regulatory record

Merck press release, 4 August 2020, on merck.com.

Merck announced an exclusive license from Hanmi Pharmaceutical to develop, manufacture and commercialize efinopegdutide in the United States and globally, with Hanmi retaining an option to commercialize in Korea. The release calls efinopegdutide, formerly HM12525A, Hanmi's investigational once-weekly GLP-1/glucagon receptor dual agonist. It says efficacy and safety were evaluated in multiple phase 1 and phase 2 trials, including in severely obese people with and without type 2 diabetes, and gives no numbers.

Participants / model
Not a clinical population
Treatment
License agreement
Follow-up
Statement dated 4 August 2020
Study design
Company press release on a license agreement; not peer reviewed
Funding
not stated in the source

The release gives no trial numbers. Milestone terms and earlier rights history are not established here and are not stated on this page.

Read the original source
Registry-posted pharmacokinetics: 22 adults, single subcutaneous dose, half-life 115 to 149 hours

Trial registry record

ClinicalTrials.gov record NCT06052566, posted results read on 10 October 2026.

A single 7 mg subcutaneous dose was given to 8 adults with moderate and 8 with severe hepatic impairment and 6 matched healthy participants. Geometric mean AUC0-inf was 143, 152 and 146 hr*ug/mL; the geometric mean ratio versus healthy participants was 0.97 (95% CI 0.61 to 1.54) for moderate and 1.04 (0.63 to 1.71) for severe impairment. Geometric mean apparent terminal half-life was 146, 149 and 115 hours. Median Tmax was 120.00, 72.04 and 83.78 hours.

Participants / model
22 adults: moderate hepatic impairment, severe hepatic impairment, and matched healthy controls
Treatment
Efinopegdutide 7 mg subcutaneous, single dose
Follow-up
Single dose
Study design
Trial registry posted results; not peer reviewed
Funding
not stated in the source

Values are listed for moderate impairment, severe impairment and healthy participants in that order. Registry-posted results are not a peer-reviewed publication, so no single half-life is entered in the structured fields.

Read the original source
2021 phase 2 under code JNJ-64565111: 195 adults with type 2 diabetes and obesity, no HbA1c change

Randomized controlled trial

Di Prospero NA et al. Clin Obes. 2021;11(2):e12433. PMID 33475251.

Placebo-subtracted body weight changes were -4.6%, -5.9% and -7.2% at 5.0, 7.4 and 10.0 mg. All doses were associated with no change in HbA1c, a slight numerical rise in fasting insulin, and numerical increases in fasting plasma glucose at 5.0 and 7.4 mg. Adverse events, especially nausea and vomiting, were more frequent than on placebo. 144 (73.8%) completed treatment.

Participants / model
195 adults with type 2 diabetes (HbA1c 6.5 to 9.5%) and class II or III obesity
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously, or placebo
Follow-up
12 weeks
Study design
Randomized double-blind phase 2 trial under the Janssen code
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111. The abstract reports weight loss without HbA1c lowering.

Read the original source

What adverse effects have been reported?

Adverse events, especially nausea and vomiting, were more frequent on efinopegdutide than on placebo in the 2021 phase 2 trials, and 72.4% and 73.8% completed treatment in the two trials. In the registry-posted phase 2a study, any adverse event occurred in 82.1% to 85.7% and discontinuation for an adverse event in 5.1% to 9.5%.

In the 2021 obesity trial, treatment-emergent adverse events, especially nausea and vomiting, were more frequent on each dose than on placebo or liraglutide, and 343 (72.4%) completed treatment. In the 2021 diabetes trial, adverse events, especially nausea and vomiting, were more frequent than on placebo, and 144 (73.8%) completed treatment. The abstracts give no reasons for non-completion.

In the open-label phase IIa liver fat trial, adverse events and drug-related adverse events were slightly more frequent with efinopegdutide than with semaglutide, mainly gastrointestinal. In the registry-posted phase 2a study (not peer reviewed), any adverse event occurred in 83.3%, 82.1% and 85.7% across the three arms, and discontinuation due to an adverse event was 7.1%, 5.1% and 9.5%.

No placebo-controlled MASH safety data are public, and no phase 3 safety data exist. Interactions are not described in the sources reviewed.

2021 phase 2 under code JNJ-64565111: 474 adults with obesity, week 26, placebo-subtracted -6.8% to -10.0%

Randomized controlled trial

Alba M et al. Clin Obes. 2021;11(2):e12432. PMID 33475255.

At week 26, placebo-subtracted body weight changes were -6.8%, -8.1% and -10.0% for the three doses (5.0, 7.4 and 10.0 mg) and -5.8% for liraglutide; 343 (72.4%) completed treatment. Treatment-emergent adverse events, especially nausea and vomiting, were more frequent on each dose than on placebo or liraglutide.

Participants / model
474 adults with class II or III obesity (BMI 35 to 50) and without type 2 diabetes
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously (no dose escalation), placebo, or open-label liraglutide 3.0 mg, randomized 1:1:2:2:2
Follow-up
26 weeks
Study design
Randomized phase 2 trial under the Janssen code, with an open-label liraglutide arm
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111, which the registry equates with efinopegdutide.

Read the original source
2021 phase 2 under code JNJ-64565111: 195 adults with type 2 diabetes and obesity, no HbA1c change

Randomized controlled trial

Di Prospero NA et al. Clin Obes. 2021;11(2):e12433. PMID 33475251.

Placebo-subtracted body weight changes were -4.6%, -5.9% and -7.2% at 5.0, 7.4 and 10.0 mg. All doses were associated with no change in HbA1c, a slight numerical rise in fasting insulin, and numerical increases in fasting plasma glucose at 5.0 and 7.4 mg. Adverse events, especially nausea and vomiting, were more frequent than on placebo. 144 (73.8%) completed treatment.

Participants / model
195 adults with type 2 diabetes (HbA1c 6.5 to 9.5%) and class II or III obesity
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously, or placebo
Follow-up
12 weeks
Study design
Randomized double-blind phase 2 trial under the Janssen code
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111. The abstract reports weight loss without HbA1c lowering.

Read the original source
Phase IIa: 145 adults with NAFLD, 24 weeks, liver fat down 72.7% versus 42.3% on semaglutide 1 mg

Randomized controlled trial

Romero-Gómez M et al. J Hepatol. 2023;79(4):888-897. PMID 37355043.

Efinopegdutide 10 mg once weekly (n=72) lowered liver fat more than semaglutide 1 mg once weekly (n=73) over 24 weeks: least-squares mean relative reduction 72.7% (90% CI 66.8 to 78.7) versus 42.3% (90% CI 36.5 to 48.1), p<0.001. Body weight fell 8.5% versus 7.1% (p=0.085). Adverse events and drug-related adverse events were slightly more frequent with efinopegdutide, mainly gastrointestinal.

Participants / model
145 adults with NAFLD and liver fat of at least 10% (mean BMI 34.3 kg/m2, mean liver fat 20.3%, 33.1% with type 2 diabetes)
Treatment
Efinopegdutide 10 mg or semaglutide 1 mg subcutaneously once weekly
Follow-up
24 weeks
Study design
Randomized open-label phase IIa trial (NCT04944992)
Funding
not stated in the source

Open-label, with an imaging endpoint (MRI-PDFF). The comparator was the 1 mg diabetes dose of semaglutide, not the 2.4 mg obesity dose.

Read the original source
Registry-posted results: 124 adults with MASLD, 28 weeks, no placebo arm, not peer reviewed

Trial registry record

ClinicalTrials.gov record NCT06482112, posted results read on 10 October 2026.

NCT06482112 is an open-label phase 2a study with no placebo arm in 124 adults with MASLD comparing efinopegdutide 10 mg weekly (n=42), 10 mg every 2 weeks (n=40) and 15 mg every 2 weeks (n=42). Mean relative reduction in liver fat at week 28 was 67.8% (90% CI 60.7 to 74.9), 54.4% (46.8 to 61.9) and 42.1% (34.6 to 49.5); body weight change was -7.5%, -3.9% and -4.1%. Any adverse event occurred in 83.3%, 82.1% and 85.7%; discontinuation due to an adverse event was 7.1%, 5.1% and 9.5%.

Participants / model
124 adults with MASLD
Treatment
Efinopegdutide subcutaneous, weekly or every 2 weeks, for 28 weeks
Follow-up
28 weeks
Study design
Trial registry posted results; open-label with no placebo arm; not peer reviewed
Funding
not stated in the source

Registry-posted results are not a peer-reviewed publication.

Read the original source

Why does efinopegdutide sit in C tier?

C reflects phase 2 evidence only. The central MASH result, a 381-patient placebo-controlled phase 2b that finished in December 2025, is not public, and the published liver fat trial used an imaging endpoint and an open-label comparator. No phase 3 is registered.

The published efficacy evidence is one open-label phase IIa liver-fat study against semaglutide 1 mg (145 patients), two 2021 Janssen phase 2 trials under the older code that showed weight loss but no HbA1c lowering in diabetes and more nausea and vomiting, and registry-posted phase 2a results from an open-label dosing study.

The only randomized placebo-controlled MASH study, the 381-patient phase 2b, finished in December 2025 with nothing posted or published, and Merck's chart still shows phase 2 with no phase 3 registered. The site grades phase 2 compounds B or C, and C fits because the central MASH result is not public and the published liver fat trial used an imaging endpoint and an open-label comparator.

Phase IIa: 145 adults with NAFLD, 24 weeks, liver fat down 72.7% versus 42.3% on semaglutide 1 mg

Randomized controlled trial

Romero-Gómez M et al. J Hepatol. 2023;79(4):888-897. PMID 37355043.

Efinopegdutide 10 mg once weekly (n=72) lowered liver fat more than semaglutide 1 mg once weekly (n=73) over 24 weeks: least-squares mean relative reduction 72.7% (90% CI 66.8 to 78.7) versus 42.3% (90% CI 36.5 to 48.1), p<0.001. Body weight fell 8.5% versus 7.1% (p=0.085). Adverse events and drug-related adverse events were slightly more frequent with efinopegdutide, mainly gastrointestinal.

Participants / model
145 adults with NAFLD and liver fat of at least 10% (mean BMI 34.3 kg/m2, mean liver fat 20.3%, 33.1% with type 2 diabetes)
Treatment
Efinopegdutide 10 mg or semaglutide 1 mg subcutaneously once weekly
Follow-up
24 weeks
Study design
Randomized open-label phase IIa trial (NCT04944992)
Funding
not stated in the source

Open-label, with an imaging endpoint (MRI-PDFF). The comparator was the 1 mg diabetes dose of semaglutide, not the 2.4 mg obesity dose.

Read the original source
2021 phase 2 under code JNJ-64565111: 474 adults with obesity, week 26, placebo-subtracted -6.8% to -10.0%

Randomized controlled trial

Alba M et al. Clin Obes. 2021;11(2):e12432. PMID 33475255.

At week 26, placebo-subtracted body weight changes were -6.8%, -8.1% and -10.0% for the three doses (5.0, 7.4 and 10.0 mg) and -5.8% for liraglutide; 343 (72.4%) completed treatment. Treatment-emergent adverse events, especially nausea and vomiting, were more frequent on each dose than on placebo or liraglutide.

Participants / model
474 adults with class II or III obesity (BMI 35 to 50) and without type 2 diabetes
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously (no dose escalation), placebo, or open-label liraglutide 3.0 mg, randomized 1:1:2:2:2
Follow-up
26 weeks
Study design
Randomized phase 2 trial under the Janssen code, with an open-label liraglutide arm
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111, which the registry equates with efinopegdutide.

Read the original source
2021 phase 2 under code JNJ-64565111: 195 adults with type 2 diabetes and obesity, no HbA1c change

Randomized controlled trial

Di Prospero NA et al. Clin Obes. 2021;11(2):e12433. PMID 33475251.

Placebo-subtracted body weight changes were -4.6%, -5.9% and -7.2% at 5.0, 7.4 and 10.0 mg. All doses were associated with no change in HbA1c, a slight numerical rise in fasting insulin, and numerical increases in fasting plasma glucose at 5.0 and 7.4 mg. Adverse events, especially nausea and vomiting, were more frequent than on placebo. 144 (73.8%) completed treatment.

Participants / model
195 adults with type 2 diabetes (HbA1c 6.5 to 9.5%) and class II or III obesity
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously, or placebo
Follow-up
12 weeks
Study design
Randomized double-blind phase 2 trial under the Janssen code
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111. The abstract reports weight loss without HbA1c lowering.

Read the original source
Registry-posted results: 124 adults with MASLD, 28 weeks, no placebo arm, not peer reviewed

Trial registry record

ClinicalTrials.gov record NCT06482112, posted results read on 10 October 2026.

NCT06482112 is an open-label phase 2a study with no placebo arm in 124 adults with MASLD comparing efinopegdutide 10 mg weekly (n=42), 10 mg every 2 weeks (n=40) and 15 mg every 2 weeks (n=42). Mean relative reduction in liver fat at week 28 was 67.8% (90% CI 60.7 to 74.9), 54.4% (46.8 to 61.9) and 42.1% (34.6 to 49.5); body weight change was -7.5%, -3.9% and -4.1%. Any adverse event occurred in 83.3%, 82.1% and 85.7%; discontinuation due to an adverse event was 7.1%, 5.1% and 9.5%.

Participants / model
124 adults with MASLD
Treatment
Efinopegdutide subcutaneous, weekly or every 2 weeks, for 28 weeks
Follow-up
28 weeks
Study design
Trial registry posted results; open-label with no placebo arm; not peer reviewed
Funding
not stated in the source

Registry-posted results are not a peer-reviewed publication.

Read the original source
Searches, 10 October 2026: phase 2b NCT05877547 completed, no results posted or published

PubMed search record

PubMed searches for efinopegdutide and for efinopegdutide AND (steatohepatitis OR MASH OR NASH OR phase 2b), run on 10 October 2026, with ClinicalTrials.gov record NCT05877547.

The phase 2b MASH trial is registered but has no posted or published results. NCT05877547 is a phase 2b randomized, double-blind, placebo-controlled study in adults with precirrhotic NASH (efinopegdutide, semaglutide and placebo are the listed interventions; primary outcome NASH resolution without worsening of fibrosis at week 52). The registry lists it as Completed, enrollment 381 (actual), primary completion 2025-12-29, last update 2026-01-12, results not posted. A PubMed search run 2026-10-10 for efinopegdutide returned 9 records, and a search adding steatohepatitis, MASH, NASH or phase 2b returned 5, none of which reports NCT05877547. Web searches run the same day found no Merck results announcement. The claim that phase 2b data are in is not supported by any record reviewed.

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

A completed study with no posted data is not an outcome. Whether Merck has presented the results at a congress is not established; the searches found none, which does not prove none exist.

Read the original source
Company pipeline chart as of 5 August 2026: phase 2 for MASH; no phase 3 registered

Regulatory record

Merck public pipeline chart as of 5 August 2026 (and the chart dated 30 April 2026), on merck.com; ClinicalTrials.gov query efinopegdutide, run on 10 October 2026.

Merck's public pipeline chart as of 2026-08-05 lists efinopegdutide (MK-6024) under Phase 2 for MASH, as did the chart dated 2026-04-30. The ClinicalTrials.gov query efinopegdutide returned 7 records on 2026-10-10, 3 phase 1 and 4 phase 2; none is a phase 3 study.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Chart dated 5 August 2026; registry query run on 10 October 2026
Study design
Company pipeline chart and registry search
Funding
not stated in the source

A pipeline chart is a company statement of development stage, not a regulator record.

Read the original source

Studies and sources

Registry: codes MK-6024, HM12525A and JNJ-64565111; no PubChem compound record

Trial registry record

ClinicalTrials.gov record NCT05877547, read on 10 October 2026, with PubChem name searches run the same day.

The ClinicalTrials.gov record NCT05877547 lists the intervention efinopegdutide with other names MK-6024, HM12525A and JNJ-64565111, and its sponsor is Merck Sharp & Dohme LLC. The same three names appear on Merck's other efinopegdutide records (NCT04944992, NCT06482112, NCT06052566). Janssen R&D authors published the 2021 phase 2 reports under the code JNJ-64565111, which the registry equates with the Merck molecule. PubChem has no compound record (CID) for efinopegdutide, MK-6024, HM12525A or JNJ-64565111. Depositor-submitted substance records exist for efinopegdutide, HM12525A and JNJ-64565111 (three substance IDs carry all three names) but link to no compound, and none exists for MK-6024, so no formula or CAS number is available from an official chemical record.

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

The three codes are tied to one molecule by the registry, not by a chemical record. Substance IDs 381128243, 404719341 and 472419764 link to no compound.

Read the original source
Company statement, 4 August 2020: Merck license from Hanmi

Regulatory record

Merck press release, 4 August 2020, on merck.com.

Merck announced an exclusive license from Hanmi Pharmaceutical to develop, manufacture and commercialize efinopegdutide in the United States and globally, with Hanmi retaining an option to commercialize in Korea. The release calls efinopegdutide, formerly HM12525A, Hanmi's investigational once-weekly GLP-1/glucagon receptor dual agonist. It says efficacy and safety were evaluated in multiple phase 1 and phase 2 trials, including in severely obese people with and without type 2 diabetes, and gives no numbers.

Participants / model
Not a clinical population
Treatment
License agreement
Follow-up
Statement dated 4 August 2020
Study design
Company press release on a license agreement; not peer reviewed
Funding
not stated in the source

The release gives no trial numbers. Milestone terms and earlier rights history are not established here and are not stated on this page.

Read the original source
Phase IIa: 145 adults with NAFLD, 24 weeks, liver fat down 72.7% versus 42.3% on semaglutide 1 mg

Randomized controlled trial

Romero-Gómez M et al. J Hepatol. 2023;79(4):888-897. PMID 37355043.

Efinopegdutide 10 mg once weekly (n=72) lowered liver fat more than semaglutide 1 mg once weekly (n=73) over 24 weeks: least-squares mean relative reduction 72.7% (90% CI 66.8 to 78.7) versus 42.3% (90% CI 36.5 to 48.1), p<0.001. Body weight fell 8.5% versus 7.1% (p=0.085). Adverse events and drug-related adverse events were slightly more frequent with efinopegdutide, mainly gastrointestinal.

Participants / model
145 adults with NAFLD and liver fat of at least 10% (mean BMI 34.3 kg/m2, mean liver fat 20.3%, 33.1% with type 2 diabetes)
Treatment
Efinopegdutide 10 mg or semaglutide 1 mg subcutaneously once weekly
Follow-up
24 weeks
Study design
Randomized open-label phase IIa trial (NCT04944992)
Funding
not stated in the source

Open-label, with an imaging endpoint (MRI-PDFF). The comparator was the 1 mg diabetes dose of semaglutide, not the 2.4 mg obesity dose.

Read the original source
2021 phase 2 under code JNJ-64565111: 474 adults with obesity, week 26, placebo-subtracted -6.8% to -10.0%

Randomized controlled trial

Alba M et al. Clin Obes. 2021;11(2):e12432. PMID 33475255.

At week 26, placebo-subtracted body weight changes were -6.8%, -8.1% and -10.0% for the three doses (5.0, 7.4 and 10.0 mg) and -5.8% for liraglutide; 343 (72.4%) completed treatment. Treatment-emergent adverse events, especially nausea and vomiting, were more frequent on each dose than on placebo or liraglutide.

Participants / model
474 adults with class II or III obesity (BMI 35 to 50) and without type 2 diabetes
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously (no dose escalation), placebo, or open-label liraglutide 3.0 mg, randomized 1:1:2:2:2
Follow-up
26 weeks
Study design
Randomized phase 2 trial under the Janssen code, with an open-label liraglutide arm
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111, which the registry equates with efinopegdutide.

Read the original source
2021 phase 2 under code JNJ-64565111: 195 adults with type 2 diabetes and obesity, no HbA1c change

Randomized controlled trial

Di Prospero NA et al. Clin Obes. 2021;11(2):e12433. PMID 33475251.

Placebo-subtracted body weight changes were -4.6%, -5.9% and -7.2% at 5.0, 7.4 and 10.0 mg. All doses were associated with no change in HbA1c, a slight numerical rise in fasting insulin, and numerical increases in fasting plasma glucose at 5.0 and 7.4 mg. Adverse events, especially nausea and vomiting, were more frequent than on placebo. 144 (73.8%) completed treatment.

Participants / model
195 adults with type 2 diabetes (HbA1c 6.5 to 9.5%) and class II or III obesity
Treatment
JNJ-64565111 5.0, 7.4 or 10.0 mg subcutaneously, or placebo
Follow-up
12 weeks
Study design
Randomized double-blind phase 2 trial under the Janssen code
Funding
not stated in the source

Published under the earlier Janssen code JNJ-64565111. The abstract reports weight loss without HbA1c lowering.

Read the original source
Registry-posted results: 124 adults with MASLD, 28 weeks, no placebo arm, not peer reviewed

Trial registry record

ClinicalTrials.gov record NCT06482112, posted results read on 10 October 2026.

NCT06482112 is an open-label phase 2a study with no placebo arm in 124 adults with MASLD comparing efinopegdutide 10 mg weekly (n=42), 10 mg every 2 weeks (n=40) and 15 mg every 2 weeks (n=42). Mean relative reduction in liver fat at week 28 was 67.8% (90% CI 60.7 to 74.9), 54.4% (46.8 to 61.9) and 42.1% (34.6 to 49.5); body weight change was -7.5%, -3.9% and -4.1%. Any adverse event occurred in 83.3%, 82.1% and 85.7%; discontinuation due to an adverse event was 7.1%, 5.1% and 9.5%.

Participants / model
124 adults with MASLD
Treatment
Efinopegdutide subcutaneous, weekly or every 2 weeks, for 28 weeks
Follow-up
28 weeks
Study design
Trial registry posted results; open-label with no placebo arm; not peer reviewed
Funding
not stated in the source

Registry-posted results are not a peer-reviewed publication.

Read the original source
Registry-posted pharmacokinetics: 22 adults, single subcutaneous dose, half-life 115 to 149 hours

Trial registry record

ClinicalTrials.gov record NCT06052566, posted results read on 10 October 2026.

A single 7 mg subcutaneous dose was given to 8 adults with moderate and 8 with severe hepatic impairment and 6 matched healthy participants. Geometric mean AUC0-inf was 143, 152 and 146 hr*ug/mL; the geometric mean ratio versus healthy participants was 0.97 (95% CI 0.61 to 1.54) for moderate and 1.04 (0.63 to 1.71) for severe impairment. Geometric mean apparent terminal half-life was 146, 149 and 115 hours. Median Tmax was 120.00, 72.04 and 83.78 hours.

Participants / model
22 adults: moderate hepatic impairment, severe hepatic impairment, and matched healthy controls
Treatment
Efinopegdutide 7 mg subcutaneous, single dose
Follow-up
Single dose
Study design
Trial registry posted results; not peer reviewed
Funding
not stated in the source

Values are listed for moderate impairment, severe impairment and healthy participants in that order. Registry-posted results are not a peer-reviewed publication, so no single half-life is entered in the structured fields.

Read the original source
Company pipeline chart as of 5 August 2026: phase 2 for MASH; no phase 3 registered

Regulatory record

Merck public pipeline chart as of 5 August 2026 (and the chart dated 30 April 2026), on merck.com; ClinicalTrials.gov query efinopegdutide, run on 10 October 2026.

Merck's public pipeline chart as of 2026-08-05 lists efinopegdutide (MK-6024) under Phase 2 for MASH, as did the chart dated 2026-04-30. The ClinicalTrials.gov query efinopegdutide returned 7 records on 2026-10-10, 3 phase 1 and 4 phase 2; none is a phase 3 study.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Chart dated 5 August 2026; registry query run on 10 October 2026
Study design
Company pipeline chart and registry search
Funding
not stated in the source

A pipeline chart is a company statement of development stage, not a regulator record.

Read the original source
US searches, 10 October 2026: no application records and no labels

Regulatory record

DailyMed, U.S. National Library of Medicine, search for efinopegdutide; openFDA Drugs@FDA search by generic name. Both run on 10 October 2026.

An openFDA Drugs@FDA search by generic name efinopegdutide returned no application records, and a DailyMed search for efinopegdutide returned 0 labels. No FDA approval or label exists in those sources.

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

A search result shows what the databases held on that date.

Read the original source

Why is Efinopegdutide in C tier?

C fits phase 2 evidence only. The central MASH result, a 381-patient placebo-controlled phase 2b that finished in December 2025, is not public, and the published liver fat trial used an imaging endpoint and an open-label comparator. No phase 3 is registered.