Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-6024, HM12525A, JNJ-64565111
Efinopegdutide · 5 trials · 10 indications
Liver fat content (LFC) was measured with liver images taken by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) and analyzed by blinded independent central review (BICR). Relative Reduction from Baseline to Week 28 = (Baseline - Week 28) / Baseline x 100%. Least Squares (LS) Mean relative reduction from baseline in LFC is presented.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who experienced an AE is presented.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants who discontinued study intervention due to an AE is presented.
Researchers will measure the change in the amount of fat in the liver using magnetic resonance imaging (MRI) after about 7 months of treatment. The change in MRI-Estimated proton density fat fraction (PDFF) will be measured from baseline to 28 weeks.
An AE is a health problem that happens or worsens during a study. The percentage of participants who stop study treatment due to an AE will be reported.
The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.
LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. Relative Reduction from Baseline to Week 24 = (Baseline - Week 24) / Baseline x 100%. Mean relative reduction from baseline in liver fat content is presented.
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.
Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.
Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.
Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide.
Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.
Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.
Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.
| Arm | Type | Description |
|---|---|---|
| Efinopegdutide Q1W 10 mg | ACTIVE_COMPARATOR | Participants will receive efinopegdutide Q1W via subcutaneous (SC) injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
| Efinopegdutide Q2W 10 mg | EXPERIMENTAL | Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for up to 16 weeks. |
| Efinopegdutide Q2W 15 mg | EXPERIMENTAL | Participants will receive efinopegdutide Q2W via SC injection for 28 weeks in a dose-escalating regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, 10 mg for 4 weeks, and 15 mg for up to 12 weeks. |
| Efinopegdutide | EXPERIMENTAL | Participants will start efinopegdutide once a week at the lowest dose level. Then, the dose level will go up every month for three months until they are getting the highest dose level. Efinopegdutide is given as an injection under the skin (subcutaneous injection) for 28 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine. Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks. |
| Efinopegdutide 4mg | EXPERIMENTAL | Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks. |
| Efinopegdutide 7mg | EXPERIMENTAL | Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks. |
| Efinopegdutide 10mg | EXPERIMENTAL | Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks. |
| Semaglutide 2.4 mg | ACTIVE_COMPARATOR | Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks. |
| Semaglutide | ACTIVE_COMPARATOR | Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24. |
| Efinopegdutide in Participants with Moderate Hepatic Impairment | EXPERIMENTAL | Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection. |
| Efinopegdutide in Participants with Severe Hepatic Impairment | EXPERIMENTAL | Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
| Efinopegdutide in Healthy-Matched Control Group | EXPERIMENTAL | Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection. |
| Name | Type | Description |
|---|---|---|
| Efinopegdutide | DRUG | SC injections in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg in all arms and 15 mg in the Efinopegdutide Q2W 15 mg arm |
| Placebo | COMBINATION_PRODUCT | Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks. |
| Semaglutide | DRUG | SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg |
| Efinopegdutide 20 mg/mL | DRUG | Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg |
| Semaglutide 1.34 mg/mL | DRUG | Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has body mass index (BMI) ≥25 kg/m\^2 (≥23 kg/m\^2 for Asian participants) AND has stable weight, defined as ≤5% gain or loss of body weight for at least 3 months before screening * Has no history of ty...
Efinopegdutide is an investigational drug being studied for metabolic dysfunction-associated steatotic liver disease (MASLD), non-alcoholic fatty liver disease (NAFLD), and non-alcoholic steatohepatitis (NASH). It is not yet approved for any indication and remains in clinical development.
Efinopegdutide targets both the glucagon receptor (GCGR) and the GLP-1 receptor (GLP1R), acting as an agonist at each. This dual agonist mechanism is designed to engage two metabolic pathways simultaneously, which is being explored for liver diseases such as MASLD and NASH.
Efinopegdutide is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical trials evaluating the drug in metabolic liver diseases.
Efinopegdutide is in Phase 2 clinical development. It has completed two Phase 2 trials and one Phase 1 trial, with no active trials currently listed. The drug is investigational and has not been approved by the FDA for any indication.
Efinopegdutide has been studied in completed trials including NCT06482112 (Phase 2, MASLD, 124 participants), NCT06465186 (Phase 2, compensated cirrhosis due to steatohepatitis, 85 participants), NCT06052566 (Phase 1, hepatic impairment, 22 participants), and NCT05877547 (Phase 2, precirrhotic NASH, 381 participants).