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(73)

Pinnacle Research Group

Anniston, Alabama, United States

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Clinical Trials

Tucson, Arizona, United States

Artemis Institute for Clinical Research, LLC

San Diego, California, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Elevate Clinical Research

Gurnee, Illinois, United States

Knownwell

Schaumburg, Illinois, United States

Monroe Biomedical Research

Louisville, Kentucky, United States

Knownwell

Needham, Massachusetts, United States

International Diabetes Center At Park Nicollet

Minneapolis, Minnesota, United States

Clinvest Research LLC

Springfield, Missouri, United States

Rochester Clinical Research

Buffalo, New York, United States

Hometown Urgent Care and Research - Dayton

Dayton, Ohio, United States

Headlands Reseach- Summit

Portland, Oregon, United States

Suburban Research Associates - West Chester Office

West Chester, Pennsylvania, United States

Trial Management Associates

Myrtle Beach, South Carolina, United States

Circle Clinical Research

Sioux Falls, South Dakota, United States

Innovative Clinical Research

Clarksville, Tennessee, United States

Clinical Research Associates

Nashville, Tennessee, United States

Bellaire Clinical Research, LLC

Bellaire, Texas, United States

University of Texas Southwestern Medical Center - Children's Medical Center Dallas

Dallas, Texas, United States

Elevate Clinical

Houston, Texas, United States

Elevate Clinical

McAllen, Texas, United States

CINME

Buenos Aires, Argentina

CEDIC Centro de Investigaciones Clinicas

Buenos Aires, Argentina

Centro Medico Viamonte SRL

Buenos Aires, Argentina

IME - Instituto Médico Especializado

Buenos Aires, Argentina

Instituto centenario

Ciudad Autonoma Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

Paratus Clinical Western Sydney

Blacktown, New South Wales, Australia

Baker Heart and Diabetes Insitute

Melbourne, Victoria, Australia

Unity Healthcare Clinic

Surrey, British Columbia, Canada

Aggarwal and Associates

Brampton, Ontario, Canada

Hamilton Medical Research Group

Hamilton, Ontario, Canada

Wharton Medical Clinic

Hamilton, Ontario, Canada

Bluewater Clinical Research Group

Sarnia, Ontario, Canada

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, Canada

MUDr. Alena Váchová, Diabetologie

České Budějovice, Czechia

CHU d'Angers

Angers, France

CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutrition

Pessac, France

CHU de Nantes - Hopital Laennec

Saint-Herblain, France

InnoDiab Forschung GmbH

Essen, Germany

Medizentrum Essen Borbeck

Essen, Germany

Unterfrintroper Hausarztzentrum

Essen, Germany

Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie

Hof, Germany

Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika

Budapest, Hungary

MED-TIMA Kft.

Budapest, Hungary

Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology

Budapest, Hungary

Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet

Debrecen, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika

Szeged, Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz;2nd Department of Internal Medicine, Nephrological and Diabetological Center

Székesfehérvár, Hungary

Kasugai Municipal Hospital

Aichi, Japan

Fukuhama Chuo Clinic

Fukuoka, Japan

NTT Medical Center Sapporo

Hokkaido, Japan

Hasegawa Medicine Clinic

Hokkaido, Japan

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, Japan

NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny

Bialystok, Poland

Centrum Medyczne Kermed Renata Bijata-Bronisz i Ewa Kowali?ska Sp.j.

Bydgoszcz, Poland

Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman

Gdynia, Poland

ETG Warszawa

Warsaw, Poland

Hospital San Rafael A Coruna

A Coruña, LA Coruna, Spain

Hospital Vithas Sevilla

Seville, Spain

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

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NCT07351045

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