Efinopegdutide for Obesity

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Endocrine, Cardiovascular, Cancer, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a new treatment, efinopegdutide, a potential drug for obesity, in individuals who are overweight. Researchers aim to assess how the body processes this medication, whether administered as a single dose or multiple doses, and examine its interaction with acetaminophen. The trial seeks healthy individuals with a body mass index (BMI) between 29 and 38, excluding those with major health issues like heart disease or cancer. Participants will receive either efinopegdutide or a placebo (a harmless pill resembling the treatment) to compare results. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that efinopegdutide is likely to be safe for humans?

Research has shown that efinopegdutide has been tested for safety in people with non-alcoholic fatty liver disease. In these studies, most participants tolerated it well, experiencing only mild to moderate side effects. These side effects included nausea and vomiting, which are common with treatments like efinopegdutide. As this clinical trial is in its early stages, the main goal is to assess its safety for humans. While early results appear promising, the early phase indicates that much remains to be learned about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Most treatments for obesity focus on lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as liraglutide and semaglutide. However, Efinopegdutide offers a unique approach. It combines dual agonism of GLP-1 and glucagon receptors, potentially enhancing weight loss by increasing energy expenditure and reducing appetite more effectively. Additionally, its subcutaneous delivery could provide a new option for those seeking alternatives to oral medications. Researchers are excited because Efinopegdutide might offer superior weight loss outcomes and improve metabolic health, making it a promising candidate in the fight against obesity.

What evidence suggests that efinopegdutide might be an effective treatment for obesity?

Research has shown that efinopegdutide, which participants in this trial may receive, is under study for its potential to treat obesity and related health issues. In studies with patients who have nonalcoholic fatty liver disease (NAFLD), efinopegdutide reduced liver fat and improved overall health. This drug targets two specific receptors in the body, helping to control blood sugar levels and potentially support weight loss. The treatment has shown promise in improving liver and metabolic health, often linked to obesity. While more research is needed to confirm its effectiveness specifically for obesity, early results are encouraging. ^{1 2 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy, overweight individuals interested in testing a new drug called Efinopegdutide. Participants should not have any significant health issues and must be willing to take the medication as directed.

Inclusion Criteria

Has body mass index (BMI) between 29 kg/m^2 and 38 kg/m^2

I am in good health overall.

Exclusion Criteria

Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or Human immunodeficiency virus (HIV)

I have had cancer before.

I have a significant history of major health issues like heart, liver, or kidney diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a single subcutaneous (SC) dose of efinopegdutide or placebo

1 week

1 visit (in-person)

Treatment Part 2

Participants receive multiple SC doses of efinopegdutide or placebo, titrated over several weeks

19 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Efinopegdutide

Trial Overview The study tests the safety of Efinopegdutide in obese but otherwise healthy people. It involves taking a single dose or multiple doses over time (in two separate parts), and also looks at how it affects acetaminophen levels in the blood.

How Is the Trial Designed?

Group I: Part 2: Efinopegdutide Experimental Treatment 2 Interventions

Part 2: Participants receive multiple SC doses of efinopegdutide titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of efinopegdutide, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83.

Group II: Part 1: Efinopegdutide Experimental Treatment 1 Intervention

Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide.

Group III: Part 2: Placebo Placebo Group 2 Interventions

Part 2: Participants receive multiple SC doses of Placebo titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of Placebo, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83.

Group IV: Part 1: Placebo Placebo Group 1 Intervention

Part 1: Participants receive a single SC dose of placebo.

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37355043/

A phase IIa active-comparator-controlled study to evaluate ... The primary efficacy endpoint was relative reduction from baseline in LFC (%) after 24 weeks of treatment. Results: Among 145 randomized participants ( ...

2. merck.com merck.com/news/merck-to-present-data-for-efinopegdutide-mk-6024-an-investigational-glp-1-glucagon-receptor-co-agonist-in-patients-with-nonalcoholic-fatty-liver-disease-nafld-at-easl-2023/

Merck to Present Data for Efinopegdutide (MK-6024), an ... Data to be shared include results from the Phase 2a clinical trial evaluating efinopegdutide in adult patients with nonalcoholic fatty liver disease (NAFLD).

3. swolverine.com swolverine.com/blogs/blog/efinopegdutide-mk-6024-dual-glp-1-glucagon-peptide-for-metabolic-liver-disease?srsltid=AfmBOorec95O83sOKrFmMV4K-2Pdu9pb6UEdvyo5_uqBxSTqUNuQggJv

Efinopegdutide (MK‑6024): Dual GLP‑1/Glucagon Peptide ... Developed by Merck, this synthetic, PEGylated peptide is engineered to improve liver fat reduction, glucose control, and cardiometabolic health.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06701305

A Study of Efinopegdutide in Healthy Obese Participants ... The goal of this study is to learn about the safety of efinopegdutide (MK-6024) and how well overweight healthy people tolerate it. Researchers also want to ...

5. trial.medpath.com trial.medpath.com/clinical-trial/50c836fce6497c9e/nct04944992-efinopegdutide-nonalcoholic-fatty-liver-disease

A Study of Efinopegdutide (MK-6024) in Participants With ... The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD.

6. adisinsight.springer.com adisinsight.springer.com/drugs/800040692

Efinopegdutide - Hanmi Pharmaceutical - AdisInsight - Springer Efinopegdutide, a glucagon/glucagon-like peptide-1 (GLP-1) dual agonist is being developed by Hanmi Pharmaceutical in collaboration with Merck & Co for the.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05877547

NCT05877547 | A Clinical Study of Efinopegdutide in ... The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

8. swolverine.com swolverine.com/blogs/blog/efinopegdutide-mk-6024-dual-glp-1-glucagon-peptide-for-metabolic-liver-disease?srsltid=AfmBOor_-O81GeiKvz9cgxWpucXaX_GDfqqc1wk6ITpwNPk0Xcsci7kK

Efinopegdutide (MK‑6024): Dual GLP‑1/Glucagon Peptide ... Developed by Merck, this synthetic, PEGylated peptide is engineered to improve liver fat reduction, glucose control, and cardiometabolic health.