Back to Trials
NCT07351045PHASE3Recruiting

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

Hoffmann-La Roche

Start Date

3/16/2026

Completion Date

8/28/2028

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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants must have at screening: 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or 2. BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight * Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations) Exclusion Criteria: * History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since. * 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) * History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening. * Poorly controlled hypertension at screening * 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. * Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication. * 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?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Obesity or Overweight

Locations

Pinnacle Research Group

Anniston, Alabama 36207

United States

Alabama Clinical Therapeutics

Birmingham, Alabama 35235

United States

University of Alabama at Birmingham

Birmingham, Alabama 35294-3360

United States

Arizona Clinical Trials

Tucson, Arizona 85711

United States

Artemis Institute for Clinical Research, LLC

San Diego, California 92123

United States

Yale University

New Haven, Connecticut 06519

United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia 30291

United States

East-West Medical Research Institute

Honolulu, Hawaii 96814

United States

Elevate Clinical Research

Gurnee, Illinois 60031

United States

Knownwell

Schaumburg, Illinois 60194

United States

Endeavor Health

Skokie, Illinois 60077

United States

Monroe Biomedical Research

Louisville, Kentucky 40213

United States

Ascension DePaul Health

New Orleans, Louisiana 70127

United States

Knownwell

Needham, Massachusetts 02492

United States

International Diabetes Center At Park Nicollet

Minneapolis, Minnesota 55416

United States

DelRicht Research at Gulfport Memorial

Gulfport, Mississippi 39503

United States

Clinvest Research LLC

Springfield, Missouri 65807

United States

Rochester Clinical Research

Buffalo, New York 14217

United States

Hometown Urgent Care and Research - Dayton

Dayton, Ohio 45424

United States

Delricht Research of Tulsa Clinical Trials

Tulsa, Oklahoma 74133

United States

Headlands Reseach- Summit

Portland, Oregon 97210

United States

Suburban Research Associates - West Chester Office

West Chester, Pennsylvania 19380

United States

Trial Management Associates

Myrtle Beach, South Carolina 29572

United States

Circle Clinical Research

Sioux Falls, South Dakota 57104

United States

Innovative Clinical Research

Clarksville, Tennessee 37040

United States

Clinical Research Associates

Nashville, Tennessee 37203

United States

Bellaire Clinical Research, LLC

Bellaire, Texas 77401

United States

South Texas Research Institute - Brownsville

Brownsville, Texas 78520

United States

South Texas Clinical Research

Corpus Christi, Texas 78404

United States

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

Dallas, Texas 75390

United States

Elevate Clinical

Houston, Texas 77058

United States

Houston Research Institute

Houston, Texas 77079

United States

Elevate Clinical

McAllen, Texas 78504

United States

Pinnacle Clinical Research - South San Antonio

San Antonio, Texas 78222

United States

IMA Clinical Research - San Antonio

San Antonio, Texas 78229

United States

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance

Southlake, Texas 76092

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

Southern Adelaide Diabetes and Endocrine Services (SADES)

Oaklands Park, South Australia 5046

Australia

Baker Heart and Diabetes Insitute

Melbourne, Victoria 3004

Australia

AZORG Campus Aalst-Moorselbaan

Aalst, 9300

Belgium

Hospital Erasme

Brussels, 1070

Belgium

UZ Leuven Gasthuisberg

Leuven, 3000

Belgium

CHU de Liège (Sart Tilman)

Liège, 4000

Belgium

AZ Delta (Campus Rumbeke)

Roeselare, 8800

Belgium

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo 01228-000

Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo 01228-200

Brazil

C-health Partners Inc

Calgary, Alberta T2V 4J2

Canada

Unity Healthcare Clinic

Surrey, British Columbia V3T 4G8

Canada

Aggarwal and Associates

Brampton, Ontario L6T 0G1

Canada

Hamilton Medical Research Group

Hamilton, Ontario L8L 5G4

Canada

Wharton Medical Clinic

Hamilton, Ontario L8L 5G8

Canada

Bluewater Clinical Research Group

Sarnia, Ontario N7T 4X3

Canada

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec G9A 4P3

Canada

Alpha Recherche Clinique

Québec, G2J0C4

Canada

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

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

Pingxiang People's Hospital

Pingxiang, 337000

China

Shanghai Pudong New Area People's Hospital

Shanghai, 201299

China

The First Affiliated Hospital of Soochow University

Suzhou, 215333

China

MUDr. Alena Váchová, Diabetologie

České Budějovice, 37011

Czechia

Edumed s.r.o.;Diabetologická ambulance

Náchod, 54701

Czechia

DIALINE s.r.o.

Plze?, 301 00

Czechia

MediSpo Clinic

Prague, 120 00

Czechia

DiaVize

Prague, 140 00

Czechia

MEDICON a.s. - Poliklinika Bud?jovická

Prague, 140 00

Czechia

CHU d'Angers

Angers, 49933

France

CHU de Rouen - HOPITAL Bois Guillaume

Bois-Guillaume, 76230

France

CHU Dijon - Hopital Francois Mitterrand

Dijon, DUMMY_VALUE

France

Hopital Européen Georges Pompidou;Service d?endocrinologie, diabétologie et nutrition

Paris, 75015

France

Groupe Hospitalier Pitié Salpétrière;Service d?endocrinologie, diabétologie et nutrition

Paris, 75671

France

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

Pessac, 33604

France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495

France

CHU DE POITIERS - Hôpital de la Milétrie

Poitiers, 86021

France

CHU de Nantes - Hopital Laennec

Saint-Herblain, 44800

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

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

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, 8230

Hungary

Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika

Budapest, 1122

Hungary

MED-TIMA Kft.

Budapest, 1132

Hungary

Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology

Budapest, 1213

Hungary

Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet

Debrecen, 4032

Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika

Szeged, 6725

Hungary

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

Székesfehérvár, 8000

Hungary

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio 00168

Italy

I.R.C.C.S Policlinico San Donato

San Donato Milanese (MI), Lombardy 20097

Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily 90127

Italy

Università Degli Studi di Pisa - Ospedale di Cisanello Pisa

Pisa, Tuscany 56124

Italy

Universita Degli Studi Di Perugia

Perugia, Umbria 06129

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

Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA

Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX

Netherlands

NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny

Bialystok, 15-435

Poland

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

Bydgoszcz, 85-231

Poland

Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman

Gdynia, 81-157

Poland

Centrum Medyczne ALL-MED

Krakow, 30-033

Poland

Gabinety Medyczne MATUSZEK

Lublin, 20-064

Poland

Centrum Medyczne Clinicly

Opole, 45-047

Poland

Osrodek Badan Klinicznych Metabolica

Tarnów, 33-100

Poland

Polsko-Amerykanskie Kliniki Serca;X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji

Tychy, 43-100

Poland

ETG Warszawa

Warsaw, 02-677

Poland

ETG Zamosc

Zamo??, 22-400

Poland

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido 13620

South Korea

Konyang University Hospital

Daejeon, 35365

South Korea

Chosun University Hospital

Gwangju, 61453

South Korea

Gachon University Gil Medical Center

Incheon, 21565

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Kangbuk Samsung Hospital

Seoul, 03181

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Hospital Universitario Marques de Valdecilla

Santander, Cantabria 39008

Spain

Hospital San Rafael A Coruna

A Coruña, LA Coruna 15006

Spain

Hospital del Mar

Barcelona, 08003

Spain

Hospital Universitario Vall d Hebron

Barcelona, 08035

Spain

Hospital Ruber Juan Bravo

Madrid, 28006

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Quironsalud Infanta Luisa

Seville, 41010

Spain

Hospital Vithas Sevilla

Seville, 41950

Spain

Hospital Universitari i Politècnic La Fe

Valencia, DUMMY_VALUE

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

Soham Staploe Medical Centre

Soham, Cambridgeshire CB75JD

United Kingdom

Rowden Surgery

Chippenham, Wiltshire SN15 2SB

United Kingdom

Monklands Hospital

Airdrie, ML6 0JS

United Kingdom

Queen Elizabeth University Hospital Glasgow

Glasgow, G51 4TF

United Kingdom

Leicester General Hospital

Leicester, LE5 4PW

United Kingdom

Hammersmith Hospital

London, W12 0HS

United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP

United Kingdom

Singleton Hospital

Swansea, SA2 8QA

United Kingdom