RecruitingPhase 3NCT07351058

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and 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 and Type 2 Diabetes

Sponsor

Hoffmann-La Roche

Enrollment

1,600 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity or Overweight Type 2 Diabetes Mellitus

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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new injectable drug, RO7795068, to see if it safely helps people with type 2 diabetes and overweight or obesity manage their blood sugar and weight. **You may be eligible if...** - You have type 2 diabetes with an HbA1c between 6.5% and 10% - You have been on stable oral diabetes medications for at least 3 months (not DPP-4 inhibitors or GLP-1 therapies) - Your BMI is 27 or higher - You have tried at least once to lose weight through diet or exercise without success - You are able to self-inject the study drug (or have help from a trained person) **You may NOT be eligible if...** - You have type 1 diabetes or a history of ketoacidosis or hyperosmolar coma - You have had severe low blood sugar episodes or hypoglycemia unawareness in the past 6 months - Your fasting blood sugar has been very high (over 270 mg/dL) during screening - Your body weight has changed by more than 5 kg in the past 3 months - Your obesity is caused by another medical condition (e.g., Cushing's syndrome) or a genetic syndrome 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(36)

Lakeview Clinical Research

Guntersville, Alabama, United States

Arizona Clinical Trials

Tucson, Arizona, United States

Orange County Research Center

Lake Forest, California, United States

Ark Clinical Research

Long Beach, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Prospective Research Innovations Inc.

Rancho Cucamonga, California, United States

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States

Progressive Medical Research

Port Orange, Florida, United States

Elevate Clinical Research

Lake Charles, Louisiana, United States

Centennial Medical Group

Columbia, Maryland, United States

Centricity Research Morehead City Multispeciality

Morehead City, North Carolina, United States

Remington Davis Inc

Columbus, Ohio, United States

Essential Medical Research

Tulsa, Oklahoma, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Circle Clinical Research

Sioux Falls, South Dakota, United States

Velocity Clinical Research

Dallas, Texas, United States

Juno Research, LLC

Houston, Texas, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Era Health Research

Redmond, Washington, United States

CINME

Buenos Aires, Argentina

Paratus Clinical Western Sydney

Blacktown, New South Wales, Australia

TGElliott Inc. dba BC Diabetes

Vancouver, British Columbia, Canada

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

LMC Clinical Research Inc

Toronto, Ontario, Canada

Kasugai Municipal Hospital

Aichi, 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

Division of Endocrinology and Metabolism;Internal Medicine

Chiang Mai, Thailand

View Full Details on ClinicalTrials.gov

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