Efinopegdutide for Nonalcoholic Steatohepatitis (NASH)

Recruiting in Palo Alto (17 mi)

+175 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine called efinopegdutide to see if it can help people with a liver disease called non-alcoholic steatohepatitis (NASH). Researchers want to find out if this medicine can reduce the symptoms of NASH without making liver scarring worse. They are also checking how safe the medicine is and how well people can tolerate it.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for individuals with NASH, a type of liver disease where fat builds up in the liver. Participants should not have other types of liver diseases, uncontrolled Type II diabetes, or a history of cirrhosis or pancreatitis. Those who've had bariatric surgery within the last 5 years are also excluded.

Inclusion Criteria

I have NASH.

Exclusion Criteria

My type II diabetes is not under control.

I have not had liver diseases other than NASH.

I have not had bariatric surgery in the last 5 years.

Treatment Details

Interventions

• Efinopegdutide (Glucagon-like peptide-1 (GLP-1) receptor agonist)
• Placebo (Placebo)
• Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist)

Trial Overview The study tests how effective Efinopegdutide is compared to a placebo in treating NASH. It aims to see if Efinopegdutide can reduce signs of NASH without worsening liver scarring. Semaglutide's effects may also be observed as part of the study.

Participant Groups

Group I: Efinopegdutide 7mg Experimental Treatment 1 Intervention

Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks.

Group II: Efinopegdutide 4mg Experimental Treatment 1 Intervention

Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.

Group III: Efinopegdutide 10mg Experimental Treatment 1 Intervention

Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks.

Group IV: Semaglutide 2.4 mg Active Control 1 Intervention

Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks.

Group V: Placebo Placebo Group 1 Intervention

Placebo administered by SC injection once weekly for 52 weeks

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University