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RECRUITING
NCT07351058
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2026-03-23

Completion Date

2028-08-07

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Placebo

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

COMBINATION_PRODUCT

Enicepatide

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

Locations (122)

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

Infinity Clinical Research

Norco, California, United States

Prospective Research Innovations Inc.

Rancho Cucamonga, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Emerson Clinical Research Institute

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

Tampa Bay Medical Research, Inc.

Clearwater, Florida, United States

Center for Diabetes, Obesity and Metabolism Inc

Pembroke Pines, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Eirvera, LLC

St. Petersburg, Florida, United States

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Elevate Clinical Research

Lake Charles, Louisiana, United States

DelRicht Clinical Research, LLC

New Orleans, 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

Lynn Institute of Norman

Norman, Oklahoma, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, 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

South Texas Research Institute - Edinburg

Edinburg, Texas, United States

HRI ? Medical Center, LLC

Houston, Texas, United States

Juno Research, LLC

Houston, Texas, United States

HRI ? Pasadena, LLC

Pasadena, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Centricity Research Suffolk Primary Care

Suffolk, Virginia, United States

Era Health Research

Redmond, Washington, 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

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Logan Hospital

Meadowbrook, Queensland, Australia

Southern Adelaide Diabetes and Endocrine Services (SADES)

Oaklands Park, South Australia, Australia

Baker Heart and Diabetes Insitute

Melbourne, Victoria, Australia

Centricity Research Calgary Endocrinology

Calgary, Alberta, Canada

TGElliott Inc. dba BC Diabetes

Vancouver, British Columbia, Canada

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Medicor Research Inc

Greater Sudbury, Ontario, Canada

LMC Clinical Research Inc

Toronto, Ontario, Canada

Diex Recherche Sherbrooke

Sherbrooke, Quebec, Canada

Clinique des maladies lipidiques de Quebec

Québec, Canada

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, China

Peking University People's Hospital

Beijing, China

Beijing Pinggu Hospital

Beijing, China

The Second People's Hospital of Hefei

Hefei, China

Huizhou Central People's Hospital

Huizhou, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Shanghai Pudong New Area People's Hospital

Shanghai, China

Shanghai Fifth People's Hospital Affiliated to Fudan University

Shanghai, China

TreDia s.r.o.;Diabetologická ambulance Praha 9

Praha 9 - Klánovice, Czechia

Hopital de la Conception

Marseille, France

CHU de Nice

Nice, France

European Hospital Georges Pompidou (HEGP)

Paris, France

Chu De Tours

Tours, France

InnoDiab Forschung GmbH

Essen, Germany

Medizentrum Essen Borbeck

Essen, Germany

Unterfrintroper Hausarztzentrum

Essen, Germany

Diabeteszentrum Hamburg West

Hamburg, Germany

Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie

Hof, Germany

Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung

Pirna, Germany

A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

Bologna, Emilia-Romagna, Italy

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily, Italy

Universita Degli Studi Di Perugia

Perugia, Umbria, Italy

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 Osteo-Medic s.c. A. Racewicz, J.Supronik

Bialystok, Podlaskie Voivodeship, Poland

Centrum Medyczne INTERCOR Sp. z o.o.

Bydgoszcz, Poland

ETG Debica

Dębica, Poland

Ekamed sp. z o.o.

Lublin, Poland

NZOZ Eskulap Pabianice

Pabianice, Poland

Centrum Medyczne OMEDICA

Poznan, Poland

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki s.c.

Ruda Śląska, Poland

ETG Siedlce

Siedlce, Poland

Panstwowy Instytut Medyczny - MSWiA

Warsaw, Poland

NZOZ Regionalna Poradnia Diabetologiczna

Wroclaw, Poland

FDI Clinical Research

San Juan, Puerto Rico

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruna, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Centro Medico Teknon

Barcelona, Spain

Hospital Gregorio Marañon

Madrid, Spain

Nuevas Tecnologias en Diabetes y Endocrinologia

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

Rajavithi Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Division of Endocrinology and Metabolism;Internal Medicine

Chiang Mai, Thailand

Songklanagarind Hospital

Hat Yai, Thailand

Thammasat University Hospital

Khlong Luang, Thailand

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool, Lancashire, United Kingdom

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Antrim Area Hospital

Antrim, United Kingdom

Southmead General Hospital

Bristol, United Kingdom

Ninewells Hospital and Medical School - Tayside Health Board

Dundee, United Kingdom

Hull Royal Infirmary

Hull, United Kingdom

HMC Health Group

London, United Kingdom

George Eliot Hospital

Nuneaton, United Kingdom

Knowle House Surgery

Plymouth, United Kingdom