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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Number of Participants Who Discontinue Study Intervention Due to an AE

Number of Participants Who Experience an Adverse Event (AE)

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.

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,061,122 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,064,380 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still occurring for this experiment?

"Affirmative. Clinicaltrials.gov demonstrates that this research study, initially posted on November 22nd 2023, is still actively recruiting patients from one site and needs 24 more participants to complete the trial."

Answered by AI

What is the scope of individuals participating in this medical experiment?

"Affirmative. According to the information published on clinicaltrials.gov, this research initiative that was first shared on November 22nd 2023 is still actively seeking participants. Specifically, 24 individuals are required from a single medical centre for enrolment in the trial."

Answered by AI

Who would be an optimal candidate for this research program?

"24 participants are sought for this trial, and the eligibility criteria prescribes that candidates must possess non-alcoholic fatty liver disease and be within 18 to 75 years of age."

Answered by AI

Does this clinical research include participants aged fifty or older?

"The age range for those that can enter this clinical trial runs from 18 to 75 years old. For individuals below the age of consent or above retirement, there are 33 and 364 separate trials respectively."

Answered by AI

Has the FDA endorsed Efinopegdutide for use in Healthy-Matched Control Group?

"Our team at Power assessed Efinopegdutide's safety in the Healthy-Matched Control Group to be a score of 1 due to this being Phase 1, meaning there is minimal evidence backing both its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)

2023. "A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052566.

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