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NCT07351058PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

3/23/2026

Completion Date

8/7/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations) * Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy. * Body mass index (BMI) ≥27.0 kg/m\^2 * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight Exclusion Criteria: * History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening * Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening * At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening * Self-reported change in body weight \>5 kg within 3 months prior to screening * Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome) * Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed. * Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) * Poorly controlled hypertension at screening * Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure * Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Interventions

COMBINATION_PRODUCT

Placebo

COMBINATION_PRODUCT

Enicepatide

Interested in This Trial?

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Conditions

Obesity or OverweightType 2 Diabetes Mellitus

Locations

Lakeview Clinical Research

Guntersville, Alabama 35976

United States

Arizona Clinical Trials

Tucson, Arizona 85711

United States

Orange County Research Center

Lake Forest, California 92630

United States

Ark Clinical Research

Long Beach, California 90815

United States

Catalina Research Institute, LLC

Montclair, California 91763

United States

Infinity Clinical Research

Norco, California 92860

United States

Prospective Research Innovations Inc.

Rancho Cucamonga, California 91730

United States

Encompass Clinical Research

Spring Valley, California 91978

United States

Emerson Clinical Research Institute

Washington D.C., District of Columbia 20009

United States

Tampa Bay Medical Research, Inc.

Clearwater, Florida 33761

United States

Center for Diabetes, Obesity and Metabolism Inc

Pembroke Pines, Florida 33024

United States

Progressive Medical Research

Port Orange, Florida 32127

United States

Eirvera, LLC

St. Petersburg, Florida 33711

United States

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia 31904

United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia 30291

United States

Elevate Clinical Research

Lake Charles, Louisiana 70605

United States

DelRicht Clinical Research, LLC

New Orleans, Louisiana 70115

United States

Centennial Medical Group

Columbia, Maryland 21045-5840

United States

Centricity Research Morehead City Multispeciality

Morehead City, North Carolina 28557

United States

Remington Davis Inc

Columbus, Ohio 43215

United States

Lynn Institute of Norman

Norman, Oklahoma 73072

United States

Lynn Health Science Institute

Oklahoma City, Oklahoma 73112

United States

Essential Medical Research

Tulsa, Oklahoma 74137

United States

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania 15240

United States

Coastal Carolina Research Center

North Charleston, South Carolina 29405

United States

Circle Clinical Research

Sioux Falls, South Dakota 57104

United States

Velocity Clinical Research

Dallas, Texas 75230

United States

South Texas Research Institute - Edinburg

Edinburg, Texas 78539

United States

HRI ? Medical Center, LLC

Houston, Texas 77004

United States

Juno Research, LLC

Houston, Texas 77040

United States

HRI ? Pasadena, LLC

Pasadena, Texas 77505

United States

DM Clinical Research

Tomball, Texas 77375

United States

Manassas Clinical Research Center

Manassas, Virginia 20110

United States

Centricity Research Suffolk Primary Care

Suffolk, Virginia 23435

United States

Era Health Research

Redmond, Washington 98052

United States

CINME

Buenos Aires, C1056ABI

Argentina

CEDIC Centro de Investigaciones Clinicas

Buenos Aires, C1060ABN

Argentina

Centro Medico Viamonte SRL

Buenos Aires, C1120AAC

Argentina

IME - Instituto Médico Especializado

Buenos Aires, C1405BCH

Argentina

Instituto centenario

Ciudad Autonoma Buenos Aires, C1204AAD

Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma Buenos Aires, C1425AGC

Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600FYK

Argentina

Paratus Clinical Western Sydney

Blacktown, New South Wales 2148

Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Logan Hospital

Meadowbrook, Queensland 4131

Australia

Southern Adelaide Diabetes and Endocrine Services (SADES)

Oaklands Park, South Australia 5046

Australia

Baker Heart and Diabetes Insitute

Melbourne, Victoria 3004

Australia

Centricity Research Calgary Endocrinology

Calgary, Alberta T2H 2G4

Canada

TGElliott Inc. dba BC Diabetes

Vancouver, British Columbia V5Y 3W2

Canada

Centricity Research Brampton Endocrinology

Brampton, Ontario L6S 0C6

Canada

Medicor Research Inc

Greater Sudbury, Ontario P3C 1X3

Canada

LMC Clinical Research Inc

Toronto, Ontario M4G 3E8

Canada

Diex Recherche Sherbrooke

Sherbrooke, Quebec J1L 0H8

Canada

Clinique des maladies lipidiques de Quebec

Québec, G1V 4W2

Canada

Huai He Hospital of Henan University

Kaifeng, Henan 475001

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu 221002

China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu 212002

China

Yan'an University Xianyang Hospital

Xianyang, Shaanxi 712000

China

Jinan Central Hospital

Jinan, Shandong 250013

China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang 315010

China

Peking University People's Hospital

Beijing, 100044

China

Beijing Pinggu Hospital

Beijing, 101200

China

The First Hospital of Jilin University

Changchun, 130021

China

The Second People's Hospital of Hefei

Hefei, 230011

China

Huizhou Central People's Hospital

Huizhou, 516001

China

Hebei Petro China Central Hospital

Langfang, 065000

China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, DUMMY_VALUE

China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, 210003

China

Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, 210008

China

Pingxiang People's Hospital

Pingxiang, 337000

China

Shanghai Pudong New Area People's Hospital

Shanghai, 201299

China

Shanghai Fifth People's Hospital Affiliated to Fudan University

Shanghai, 201304

China

The First Affiliated Hospital of Soochow University

Suzhou, 215333

China

Wuxi People's Hospital

Wuxi, 214023

China

DIACENTRUM Brandýs nad Labem s.r.o.

Brandýs nad Labem, 25001

Czechia

Diavital Jesenice s.r.o.

Jesenice, 25242

Czechia

FLEDIP s.r.o.

Prague, 160 00

Czechia

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

Praha 9 - Klánovice, 19014

Czechia

Hopital Saint Joseph Saint Luc

Lyon, 69007

France

Hopital de la Conception

Marseille, 13000

France

CHU de Nice

Nice, 06602

France

European Hospital Georges Pompidou (HEGP)

Paris, 75908

France

Chu De Tours

Tours, 37000

France

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

Erlangen, 91054

Germany

InnoDiab Forschung GmbH

Essen, 45136

Germany

Medizentrum Essen Borbeck

Essen, 45355

Germany

Unterfrintroper Hausarztzentrum

Essen, 45359

Germany

Universitaets Klinikum Frankfurt - Zentrum der Inneren Medizin

Frankfurt, 60596

Germany

Diabeteszentrum Hamburg West

Hamburg, 22607

Germany

Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie

Hof, 95030

Germany

Zentrum für klinische Forschung Köln - Dünnwald;Dünnwald Praxis

Köln - Dünnwald, 51069

Germany

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

Münster, 48153

Germany

Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung

Pirna, 01796

Germany

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Abruzzo 24127

Italy

Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro

Catanzaro, Calabria 88100

Italy

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

Bologna, Emilia-Romagna 40138

Italy

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio 00161

Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio 00168

Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily 90127

Italy

AO di Perugia - Ospedale S. Maria della Misericordia

Perugia, Umbria 06156

Italy

Kasugai Municipal Hospital

Aichi, 486-8510

Japan

Fukuhama Chuo Clinic

Fukuoka, 810-0066

Japan

NTT Medical Center Sapporo

Hokkaido, 060-0061

Japan

Hasegawa Medicine Clinic

Hokkaido, 066-0032

Japan

The University of Osaka Hospital

Osaka, 565-0871

Japan

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, 114-0001

Japan

Arechavaleta Granell Maria del Rosario

Guadalajara, Jalisco 44650

Mexico

Clinicos Asociados Bocm, S.C.

México, Mexico CITY (federal District) 03300

Mexico

Avant Santé Research Center

San Pedro Garza García, Nuevo León 66260

Mexico

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

Bialystok, Podlaskie Voivodeship 15-351

Poland

Centrum Medyczne INTERCOR Sp. z o.o.

Bydgoszcz, 85-605

Poland

ETG Debica

Dębica, 39-200

Poland

Ekamed sp. z o.o.

Lublin, 20-718

Poland

NZOZ Eskulap Pabianice

Pabianice, 95-200

Poland

Centrum Medyczne OMEDICA

Poznan, 60-111

Poland

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

Ruda Śląska, 41-709

Poland

ETG Siedlce

Siedlce, 08-110

Poland

Panstwowy Instytut Medyczny - MSWiA

Warsaw, 02-507

Poland

NZOZ Regionalna Poradnia Diabetologiczna

Wroclaw, 50-127

Poland

FDI Clinical Research

San Juan, 00927

Puerto Rico

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido 13620

South Korea

Yonsei University Wonju Severance Christian Hospital

Gangwon-do, 26426

South Korea

Chosun University Hospital

Gwangju, 61453

South Korea

Eulji General Hospital

Seoul, 01830

South Korea

Kangbuk Samsung Hospital

Seoul, 03181

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona 08916

Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruna 15006

Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Centro Medico Teknon

Barcelona, 08022

Spain

Hospital Universitari Vall d Hebron

Barcelona, 08035

Spain

Hospital Gregorio Marañon

Madrid, 28007

Spain

Hospital Universitario Fundacion Jimenez Diaz.

Madrid, 28040

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010

Spain

Nuevas Tecnologias en Diabetes y Endocrinologia

Seville, 41003

Spain

Changhua Christian Hospital

Changhua, 50006

Taiwan

Chia-Yi Christian Hospital

Chiayi City, 600

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756

Taiwan

Chung Shan Medical University Hospital

Taichung, 40201

Taiwan

China Medical University Hospital

Taichung, 40447

Taiwan

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

National Taiwan University Hospital

Taipei, 10048

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan

Rajavithi Hospital

Bangkok, 10400

Thailand

Ramathibodi Hospital

Bangkok, 10400

Thailand

Siriraj Hospital

Bangkok, 10700

Thailand

Division of Endocrinology and Metabolism;Internal Medicine

Chiang Mai, 50200

Thailand

Songklanagarind Hospital

Hat Yai, 90110

Thailand

Thammasat University Hospital

Khlong Luang, 12120

Thailand

Ankara University Medical Faculty

Ankara, 06100

Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, 07059

Turkey (Türkiye)

Dokuz Eylul University Medicine Faculty

Izmir, 35340

Turkey (Türkiye)

Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi

Sariçam, 01250

Turkey (Türkiye)

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool, Lancashire FY3 7EN

United Kingdom

Aberdeen Royal Infirmary

Aberdeen, AB9 2ZB

United Kingdom

Antrim Area Hospital

Antrim, BT41 2RL

United Kingdom

Southmead General Hospital

Bristol, BS10 5NB

United Kingdom

Ninewells Hospital and Medical School - Tayside Health Board

Dundee, DD1 9SY

United Kingdom

Hull Royal Infirmary

Hull, HU3 2JZ

United Kingdom

HMC Health Group

London, TW47NR

United Kingdom

George Eliot Hospital

Nuneaton, CV10 7DJ

United Kingdom

Knowle House Surgery

Plymouth, PL5 3JB

United Kingdom

Musgrove Park Hospital

Taunton, TA1 5DA

United Kingdom