RecruitingPhase 3NCT07351045

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

Sponsor

Hoffmann-La Roche

Enrollment

2,000 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity or Overweight

Summary

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests RO7795068, a new injectable medication, to see if it helps people who are overweight or obese (without type 2 diabetes) lose weight safely. You may be eligible if... - Your BMI is 30 or higher, OR your BMI is 27–30 with at least one weight-related condition (e.g., prediabetes, high blood pressure, sleep apnea, or heart disease) - You have tried and failed at least one diet or exercise weight loss effort - You are able and willing to self-administer the study drug You may NOT be eligible if... - You have type 1 or type 2 diabetes, or a history of diabetic ketoacidosis - Your weight has changed by more than 5 kg in the past 3 months - Your obesity is caused by a hormonal or genetic condition (e.g., Cushing's syndrome, Prader-Willi) - You have had or plan to have surgery for obesity (liposuction done over 1 year ago may be allowed) - You have a known stomach emptying disorder, pancreatitis history, or gallbladder disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPlacebo

Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.

COMBINATION_PRODUCTEnicepatide

Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Locations(28)

Pinnacle Research Group

Anniston, Alabama, United States

Arizona Clinical Trials

Tucson, Arizona, United States

Artemis Institute for Clinical Research, LLC

San Diego, California, United States

Elevate Clinical Research

Gurnee, Illinois, United States

Monroe Biomedical Research

Louisville, Kentucky, United States

International Diabetes Center At Park Nicollet

Minneapolis, Minnesota, United States

Clinvest Research LLC

Springfield, Missouri, United States

Headlands Reseach- Summit

Portland, Oregon, United States

Trial Management Associates

Myrtle Beach, South Carolina, United States

Clinical Research Associates

Nashville, Tennessee, United States

Elevate Clinical

Houston, Texas, United States

Elevate Clinical

McAllen, Texas, United States

CINME

Buenos Aires, Argentina

Paratus Clinical Western Sydney

Blacktown, New South Wales, Australia

Aggarwal and Associates

Brampton, Ontario, Canada

Wharton Medical Clinic

Hamilton, Ontario, Canada

Kasugai Municipal Hospital

Aichi, Japan

NTT Medical Center Sapporo

Hokkaido, Japan

Hasegawa Medicine Clinic

Hokkaido, Japan

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, Japan

Changhua Christian Hospital

Changhua, Taiwan

Chia-Yi Christian Hospital

Chiayi City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07351045

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