Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Efinopegdutide
Efinopegdutide/mL · 1 trial · 2 indications
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.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an adverse event is presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to adverse event is presented.
| Arm | Type | Description |
|---|---|---|
| Efinopegdutide | EXPERIMENTAL | Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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: * LFC ≥10% as assessed by MRI-PDFF at time of screening. * Body Mass Index (BMI) ≥25 kg/m² and ≤50 kg/m² at time of screening. * Stable weight (based on self-reporting) defined as ≤5% gain or loss of body weight for at least 3 months before screening visit. * No history of Type ...
Efinopegdutide is an investigational small molecule being studied for non-alcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), and metabolic dysfunction-associated steatotic liver disease (MASLD). It is also being evaluated in healthy volunteers and in people with hepatic impairment or compensated cirrhosis due to steatohepatitis.
Efinopegdutide is a peptide-based small molecule, classified under the -tide (peptide) target class. Its specific molecular target is not disclosed in the available clinical trial information, so its precise mechanism of action is not detailed here.
Efinopegdutide is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug for liver diseases such as NASH and NAFLD.
Efinopegdutide is in clinical development, with trials listed as Phase 1 and Phase 2. The Phase 2 study is active but not recruiting, while the Phase 1 studies have been completed. It is not FDA approved and remains investigational.
Efinopegdutide has been studied in several trials, including NCT06052566 in participants with hepatic impairment, NCT06465186 in people with compensated cirrhosis due to steatohepatitis, NCT06701305 in healthy obese participants, and NCT06836037 in healthy Chinese volunteers. These trials cover Phase 1 and Phase 2 stages.
Yes, Efinopegdutide is also known as MK-6024. Clinical trial titles reference MK-6024 in studies such as NCT06052566 and NCT06465186, confirming that these names refer to the same investigational drug.