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Efinopegdutide for Liver Disease

Phase 1
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The main inclusion
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 4, day 5, day 6, day 7, day 8, day 11, day 14, day 21, and day 35
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well a drug works and its safety in people with liver problems vs. healthy people.

Who is the study for?
This study is for people with different levels of liver disease, including fatty liver and non-alcoholic fatty liver disease. Participants will either have impaired liver function or be healthy volunteers for comparison.
What is being tested?
The trial is testing Efinopegdutide to see how the drug behaves in the body (its pharmacokinetics) when given to people with varying degrees of liver health compared to those who are healthy.
What are the potential side effects?
While specific side effects aren't listed, the trial will monitor how safe and tolerable Efinopegdutide is, which means they'll look out for any negative reactions participants might have.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 4, day 5, day 6, day 7, day 8, day 11, day 14, day 21, and day 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 4, day 5, day 6, day 7, day 8, day 11, day 14, day 21, and day 35 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent Total Clearance (CL/F) of Efinopegdutide
Apparent Volume of Distribution (Vz/F) of Efinopegdutide
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide
+3 more
Secondary study objectives
Number of Participants Who Discontinue Study Intervention Due to an AE
Number of Participants Who Experience an Adverse Event (AE)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Efinopegdutide in Participants with Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with severe hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.
Group II: Efinopegdutide in Participants with Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment receive a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.
Group III: Efinopegdutide in Healthy-Matched Control GroupExperimental Treatment1 Intervention
Healthy matched participants receive a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
4,006 Previous Clinical Trials
5,185,484 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
975 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,882 Previous Clinical Trials
8,089,151 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
667 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~2 spots leftby Jan 2025
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