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(164)

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

Yale University

New Haven, Connecticut, 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

Endeavor Health

Skokie, Illinois, United States

Monroe Biomedical Research

Louisville, Kentucky, United States

Ascension DePaul Health

New Orleans, Louisiana, United States

Knownwell

Needham, Massachusetts, United States

International Diabetes Center At Park Nicollet

Minneapolis, Minnesota, United States

DelRicht Research at Gulfport Memorial

Gulfport, Mississippi, 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

Delricht Research of Tulsa Clinical Trials

Tulsa, Oklahoma, 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

South Texas Research Institute - Brownsville

Brownsville, Texas, United States

South Texas Clinical Research

Corpus Christi, Texas, United States

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

Dallas, Texas, United States

Elevate Clinical

Houston, Texas, United States

Houston Research Institute

Houston, Texas, United States

Elevate Clinical

McAllen, Texas, United States

Pinnacle Clinical Research - South San Antonio

San Antonio, Texas, United States

IMA Clinical Research - San Antonio

San Antonio, Texas, United States

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

Southlake, 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

Southern Adelaide Diabetes and Endocrine Services (SADES)

Oaklands Park, South Australia, Australia

Baker Heart and Diabetes Insitute

Melbourne, Victoria, Australia

AZORG Campus Aalst-Moorselbaan

Aalst, Belgium

Hospital Erasme

Brussels, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

CHU de Liège (Sart Tilman)

Liège, Belgium

AZ Delta (Campus Rumbeke)

Roeselare, Belgium

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo, Brazil

C-health Partners Inc

Calgary, Alberta, Canada

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

Alpha Recherche Clinique

Québec, Canada

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, China

Jinan Central Hospital

Jinan, Shandong, 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

Pingxiang People's Hospital

Pingxiang, China

Shanghai Pudong New Area People's Hospital

Shanghai, China

The First Affiliated Hospital of Soochow University

Suzhou, China

MUDr. Alena Váchová, Diabetologie

České Budějovice, Czechia

Edumed s.r.o.;Diabetologická ambulance

Náchod, Czechia

DIALINE s.r.o.

Plze?, Czechia

MediSpo Clinic

Prague, Czechia

DiaVize

Prague, Czechia

MEDICON a.s. - Poliklinika Bud?jovická

Prague, Czechia

CHU d'Angers

Angers, France

CHU de Rouen - HOPITAL Bois Guillaume

Bois-Guillaume, France

CHU Dijon - Hopital Francois Mitterrand

Dijon, France

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

Paris, France

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

Paris, France

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

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

CHU DE POITIERS - Hôpital de la Milétrie

Poitiers, France

CHU de Nantes - Hopital Laennec

Saint-Herblain, 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

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

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, Hungary

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

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

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

San Donato Milanese (MI), Lombardy, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily, Italy

Università Degli Studi di Pisa - Ospedale di Cisanello Pisa

Pisa, Tuscany, 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

The University of Osaka Hospital

Osaka, Japan

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, Japan

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

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

Centrum Medyczne ALL-MED

Krakow, Poland

Gabinety Medyczne MATUSZEK

Lublin, Poland

Centrum Medyczne Clinicly

Opole, Poland

Osrodek Badan Klinicznych Metabolica

Tarnów, Poland

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

Tychy, Poland

ETG Warszawa

Warsaw, Poland

ETG Zamosc

Zamo??, Poland

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, South Korea

Konyang University Hospital

Daejeon, South Korea

Chosun University Hospital

Gwangju, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital San Rafael A Coruna

A Coruña, LA Coruna, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitario Vall d Hebron

Barcelona, Spain

Hospital Ruber Juan Bravo

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Quironsalud Infanta Luisa

Seville, Spain

Hospital Vithas Sevilla

Seville, Spain

Hospital Universitari i Politècnic La Fe

Valencia, 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

Soham Staploe Medical Centre

Soham, Cambridgeshire, United Kingdom

Rowden Surgery

Chippenham, Wiltshire, United Kingdom

Monklands Hospital

Airdrie, United Kingdom

Queen Elizabeth University Hospital Glasgow

Glasgow, United Kingdom

Leicester General Hospital

Leicester, United Kingdom

Hammersmith Hospital

London, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Singleton Hospital

Swansea, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07351045

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