Liver Disease, Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease
Conditions
Brief summary
This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and tolerability of the different regimens of efinopegdutide.
Interventions
DRUGEfinopegdutide
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
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 type 2 diabetes mellitus (T2DM) OR has a history of T2DM with a glycated hemoglobin (A1C) ≤9% AND the T2DM is controlled by diet or stable doses of oral antihyperglycemic agents (AHAs)
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Relative Reduction From Baseline in Liver Fat Content at Week 28 | Baseline and Week 28 | 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. |
| Percentage of Participants Who Experienced an Adverse Event (AE) | Up to Week 32 | 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. |
| Percentage of Participants Who Discontinued Study Intervention Due to an AE | Up to Week 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Body Weight at Week 28 | Baseline and Week 28 | Body weight in kilograms was measured using a standardized, digital scale. Mean percent change in body weight from Baseline to Week 28 = (Week 28 - Baseline) / Baseline x 100%. The LS mean percent change from baseline in body weight at 28 weeks is presented. |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp and Dohme LLC
Participant flow
Pre-assignment details
Participants were randomized to 1 of 3 efinopegdutide regimen groups: 10 mg once weekly (Q1W), 10 mg every 2 weeks (Q2W), or 15 mg Q2W.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 107 Participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 15 Participants |
| Weight | 108.4 kg STANDARD_DEVIATION 24.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 40 | 0 / 42 |
| other Total, other adverse events | 30 / 42 | 27 / 39 | 33 / 42 |
| serious Total, serious adverse events | 3 / 42 | 2 / 39 | 4 / 42 |
Outcome results
None listed