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(163)

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

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 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

Huai He Hospital of Henan University

Kaifeng, Henan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, China

Jinan Central Hospital

Jinan, Shandong, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Peking University People's Hospital

Beijing, China

Beijing Pinggu Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

The Second People's Hospital of Hefei

Hefei, China

Huizhou Central People's Hospital

Huizhou, China

Hebei Petro China Central Hospital

Langfang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, China

Pingxiang People's Hospital

Pingxiang, China

Shanghai Pudong New Area People's Hospital

Shanghai, China

Shanghai Fifth People's Hospital Affiliated to Fudan University

Shanghai, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Wuxi People's Hospital

Wuxi, China

DIACENTRUM Brandýs nad Labem s.r.o.

Brandýs nad Labem, Czechia

Diavital Jesenice s.r.o.

Jesenice, Czechia

FLEDIP s.r.o.

Prague, Czechia

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

Praha 9 - Klánovice, Czechia

Hopital Saint Joseph Saint Luc

Lyon, France

Hopital de la Conception

Marseille, France

CHU de Nice

Nice, France

European Hospital Georges Pompidou (HEGP)

Paris, France

Chu De Tours

Tours, France

Hector-Center für Ernährung, Bewegung und Sport, Universitätsklinikum Erlangen;Medizinische Klinik 1 ? Gastroenterologie, Pneumologie und Endokrinologie

Erlangen, Germany

InnoDiab Forschung GmbH

Essen, Germany

Medizentrum Essen Borbeck

Essen, Germany

Unterfrintroper Hausarztzentrum

Essen, Germany

Universitaets Klinikum Frankfurt - Zentrum der Inneren Medizin

Frankfurt, Germany

Diabeteszentrum Hamburg West

Hamburg, Germany

Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie

Hof, Germany

Zentrum für klinische Forschung Köln - Dünnwald;Dünnwald Praxis

Köln - Dünnwald, Germany

Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Dr. med. Winfried Keuthage

Münster, Germany

Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung

Pirna, Germany

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Abruzzo, Italy

Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro

Catanzaro, Calabria, Italy

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

AO di Perugia - Ospedale S. Maria della Misericordia

Perugia, Umbria, Italy

Kasugai Municipal Hospital

Aichi, Japan

Fukuhama Chuo Clinic

Fukuoka, Japan

NTT Medical Center Sapporo

Hokkaido, Japan

Hasegawa Medicine Clinic

Hokkaido, Japan

The University of Osaka Hospital

Osaka, Japan

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, Japan

Arechavaleta Granell Maria del Rosario

Guadalajara, Jalisco, Mexico

Clinicos Asociados Bocm, S.C.

México, Mexico CITY (federal District), Mexico

Avant Santé Research Center

San Pedro Garza García, Nuevo León, Mexico

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

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, South Korea

Yonsei University Wonju Severance Christian Hospital

Gangwon-do, South Korea

Chosun University Hospital

Gwangju, South Korea

Eulji General Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

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 Universitari Vall d Hebron

Barcelona, Spain

Hospital Gregorio Marañon

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz.

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, 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

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Dokuz Eylul University Medicine Faculty

Izmir, Turkey (Türkiye)

Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi

Sariçam, 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

Musgrove Park Hospital

Taunton, United Kingdom

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NCT07351058

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(163)

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