Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04944992 | A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001) | PHASE2 | COMPLETED | 145 | — | — | Aug 4, 2021 | Oct 19, 2022 | Nov 15, 2023 | 69 | United States, Argentina +14 |
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 ...