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

NCT07351045 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: WC457252025-523104-71-00
• Study Type: interventional
• Target: 2,000
• Locations: 19 countries
• Sites: 164

Brief 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.

Conditions

Obesity or Overweight

Outcome Measures

Primary Outcomes (1)

• Percent (%) Change from Baseline in Body Weight at Week 72

  Baseline through Week 72

Secondary Outcomes (43)

• Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72

  Baseline and Week 72

• Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72

  Baseline and Week 72

• Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72

  Baseline and Week 72

• Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72

  Baseline and Week 72

• Percentage of Participants Achieving ≥25% Body Weight Loss from Baseline at Week 72

  Baseline and Week 72

Study Arms (4)

Arm 1: Placebo

PLACEBO COMPARATOR

Combination Product: Placebo

Arm 2: Enicepatide Dosing Regimen 1

EXPERIMENTAL

Combination Product: Enicepatide

Arm 3: Enicepatide Dosing Regimen 2

EXPERIMENTAL

Combination Product: Enicepatide

Arm 4: Enicepatide Dosing Regimen 3

EXPERIMENTAL

Combination Product: Enicepatide

Interventions

Placebo COMBINATION_PRODUCT

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

Arm 1: Placebo

Enicepatide COMBINATION_PRODUCT

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

Also known as: RO7795068, CT-388, RG6640

Arm 2: Enicepatide Dosing Regimen 1; Arm 3: Enicepatide Dosing Regimen 2; Arm 4: Enicepatide Dosing Regimen 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have at screening:
• Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (164)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

RECRUITING

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

RECRUITING

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3360, United States

RECRUITING

Arizona Clinical Trials

Tucson, Arizona, 85711, United States

RECRUITING

Artemis Institute for Clinical Research, LLC

San Diego, California, 92123, United States

RECRUITING

Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

RECRUITING

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

RECRUITING

Elevate Clinical Research

Gurnee, Illinois, 60031, United States

RECRUITING

Knownwell

Schaumburg, Illinois, 60194, United States

RECRUITING

Endeavor Health

Skokie, Illinois, 60077, United States

RECRUITING

Monroe Biomedical Research

Louisville, Kentucky, 40213, United States

RECRUITING

Ascension DePaul Health

New Orleans, Louisiana, 70127, United States

RECRUITING

Knownwell

Needham, Massachusetts, 02492, United States

RECRUITING

International Diabetes Center At Park Nicollet

Minneapolis, Minnesota, 55416, United States

RECRUITING

DelRicht Research at Gulfport Memorial

Gulfport, Mississippi, 39503, United States

RECRUITING

Clinvest Research LLC

Springfield, Missouri, 65807, United States

RECRUITING

Rochester Clinical Research

Buffalo, New York, 14217, United States

RECRUITING

Hometown Urgent Care and Research - Dayton

Dayton, Ohio, 45424, United States

RECRUITING

Delricht Research of Tulsa Clinical Trials

Tulsa, Oklahoma, 74133, United States

RECRUITING

Headlands Reseach- Summit

Portland, Oregon, 97210, United States

RECRUITING

Suburban Research Associates - West Chester Office

West Chester, Pennsylvania, 19380, United States

RECRUITING

Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Circle Clinical Research

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Innovative Clinical Research

Clarksville, Tennessee, 37040, United States

RECRUITING

Clinical Research Associates

Nashville, Tennessee, 37203, United States

RECRUITING

Bellaire Clinical Research, LLC

Bellaire, Texas, 77401, United States

RECRUITING

South Texas Research Institute - Brownsville

Brownsville, Texas, 78520, United States

RECRUITING

South Texas Clinical Research

Corpus Christi, Texas, 78404, United States

RECRUITING

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

Dallas, Texas, 75390, United States

RECRUITING

Elevate Clinical

Houston, Texas, 77058, United States

RECRUITING

Houston Research Institute

Houston, Texas, 77079, United States

RECRUITING

Elevate Clinical

McAllen, Texas, 78504, United States

RECRUITING

Pinnacle Clinical Research - South San Antonio

San Antonio, Texas, 78222, United States

RECRUITING

IMA Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

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

Southlake, Texas, 76092, United States

RECRUITING

CINME

Buenos Aires, C1056ABI, Argentina

RECRUITING

CEDIC Centro de Investigaciones Clinicas

Buenos Aires, C1060ABN, Argentina

RECRUITING

Centro Medico Viamonte SRL

Buenos Aires, C1120AAC, Argentina

RECRUITING

IME - Instituto Médico Especializado

Buenos Aires, C1405BCH, Argentina

RECRUITING

Instituto centenario

Ciudad Autonoma Buenos Aires, C1204AAD, Argentina

RECRUITING

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma Buenos Aires, C1425AGC, Argentina

RECRUITING

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600FYK, Argentina

RECRUITING

Paratus Clinical Western Sydney

Blacktown, New South Wales, 2148, Australia

RECRUITING

Southern Adelaide Diabetes and Endocrine Services (SADES)

Oaklands Park, South Australia, 5046, Australia

RECRUITING

Baker Heart and Diabetes Insitute

Melbourne, Victoria, 3004, Australia

RECRUITING

AZORG Campus Aalst-Moorselbaan

Aalst, 9300, Belgium

RECRUITING

Hospital Erasme

Brussels, 1070, Belgium

RECRUITING

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

CHU de Liège (Sart Tilman)

Liège, 4000, Belgium

RECRUITING

AZ Delta (Campus Rumbeke)

Roeselare, 8800, Belgium

RECRUITING

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, 01228-000, Brazil

RECRUITING

Centro de Pesquisas Clinicas

São Paulo, São Paulo, 01228-200, Brazil

RECRUITING

C-health Partners Inc

Calgary, Alberta, T2V 4J2, Canada

RECRUITING

Unity Healthcare Clinic

Surrey, British Columbia, V3T 4G8, Canada

RECRUITING

Aggarwal and Associates

Brampton, Ontario, L6T 0G1, Canada

RECRUITING

Hamilton Medical Research Group

Hamilton, Ontario, L8L 5G4, Canada

RECRUITING

Wharton Medical Clinic

Hamilton, Ontario, L8L 5G8, Canada

RECRUITING

Bluewater Clinical Research Group

Sarnia, Ontario, N7T 4X3, Canada

RECRUITING

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, G9A 4P3, Canada

RECRUITING

Alpha Recherche Clinique

Québec, G2J0C4, Canada

RECRUITING

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212002, China

RECRUITING

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, 712000, China

RECRUITING

Jinan Central Hospital

Jinan, Shandong, 250013, China

RECRUITING

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

Beijing Pinggu Hospital

Beijing, 101200, China

RECRUITING

The First Hospital of Jilin University

Changchun, 130021, China

RECRUITING

The Second People's Hospital of Hefei

Hefei, 230011, China

RECRUITING

Huizhou Central People's Hospital

Huizhou, 516001, China

RECRUITING

Hebei Petro China Central Hospital

Langfang, 065000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, DUMMY_VALUE, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, 210003, China

RECRUITING

Pingxiang People's Hospital

Pingxiang, 337000, China

RECRUITING

Shanghai Pudong New Area People's Hospital

Shanghai, 201299, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, 215333, China

RECRUITING

MUDr. Alena Váchová, Diabetologie

České Budějovice, 37011, Czechia

RECRUITING

Edumed s.r.o.;Diabetologická ambulance

Náchod, 54701, Czechia

RECRUITING

DIALINE s.r.o.

Plze?, 301 00, Czechia

RECRUITING

MediSpo Clinic

Prague, 120 00, Czechia

RECRUITING

DiaVize

Prague, 140 00, Czechia

RECRUITING

MEDICON a.s. - Poliklinika Bud?jovická

Prague, 140 00, Czechia

RECRUITING

CHU d'Angers

Angers, 49933, France

RECRUITING

CHU de Rouen - HOPITAL Bois Guillaume

Bois-Guillaume, 76230, France

RECRUITING

CHU Dijon - Hopital Francois Mitterrand

Dijon, DUMMY_VALUE, France

RECRUITING

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

Paris, 75015, France

RECRUITING

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

Paris, 75671, France

RECRUITING

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

Pessac, 33604, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

CHU DE POITIERS - Hôpital de la Milétrie

Poitiers, 86021, France

RECRUITING

CHU de Nantes - Hopital Laennec

Saint-Herblain, 44800, France

RECRUITING

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

Erlangen, 91054, Germany

RECRUITING

InnoDiab Forschung GmbH

Essen, 45136, Germany

RECRUITING

Medizentrum Essen Borbeck

Essen, 45355, Germany

RECRUITING

Unterfrintroper Hausarztzentrum

Essen, 45359, Germany

RECRUITING

Diabeteszentrum Hamburg West

Hamburg, 22607, Germany

RECRUITING

Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie

Hof, 95030, Germany

RECRUITING

Zentrum für klinische Forschung Köln - Dünnwald;Dünnwald Praxis

Köln - Dünnwald, 51069, Germany

RECRUITING

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

Münster, 48153, Germany

RECRUITING

Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung

Pirna, 01796, Germany

RECRUITING

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, 8230, Hungary

RECRUITING

Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika

Budapest, 1122, Hungary

RECRUITING

MED-TIMA Kft.

Budapest, 1132, Hungary

RECRUITING

Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology

Budapest, 1213, Hungary

RECRUITING

Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet

Debrecen, 4032, Hungary

RECRUITING

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika

Szeged, 6725, Hungary

RECRUITING

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

Székesfehérvár, 8000, Hungary

RECRUITING

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Abruzzo, 24127, Italy

RECRUITING

Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro

Catanzaro, Calabria, 88100, Italy

RECRUITING

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

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

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

San Donato Milanese (MI), Lombardy, 20097, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily, 90127, Italy

RECRUITING

Università Degli Studi di Pisa - Ospedale di Cisanello Pisa

Pisa, Tuscany, 56124, Italy

RECRUITING

Universita Degli Studi Di Perugia

Perugia, Umbria, 06129, Italy

RECRUITING

Kasugai Municipal Hospital

Aichi, 486-8510, Japan

RECRUITING

Fukuhama Chuo Clinic

Fukuoka, 810-0066, Japan

RECRUITING

NTT Medical Center Sapporo

Hokkaido, 060-0061, Japan

RECRUITING

Hasegawa Medicine Clinic

Hokkaido, 066-0032, Japan

RECRUITING

The University of Osaka Hospital

Osaka, 565-0871, Japan

RECRUITING

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, 114-0001, Japan

RECRUITING

Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA, Netherlands

RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny

Bialystok, 15-435, Poland

RECRUITING

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

Bydgoszcz, 85-231, Poland

RECRUITING

Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman

Gdynia, 81-157, Poland

RECRUITING

Centrum Medyczne ALL-MED

Krakow, 30-033, Poland

RECRUITING

Gabinety Medyczne MATUSZEK

Lublin, 20-064, Poland

RECRUITING

Centrum Medyczne Clinicly

Opole, 45-047, Poland

RECRUITING

Osrodek Badan Klinicznych Metabolica

Tarnów, 33-100, Poland

RECRUITING

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

Tychy, 43-100, Poland

RECRUITING

ETG Warszawa

Warsaw, 02-677, Poland

RECRUITING

ETG Zamosc

Zamo??, 22-400, Poland

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, 13620, South Korea

RECRUITING

Konyang University Hospital

Daejeon, 35365, South Korea

RECRUITING

Chosun University Hospital

Gwangju, 61453, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital San Rafael A Coruna

A Coruña, LA Coruna, 15006, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Universitario Vall d Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Ruber Juan Bravo

Madrid, 28006, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

RECRUITING

Hospital Vithas Sevilla

Seville, 41950, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, DUMMY_VALUE, Spain

RECRUITING

Changhua Christian Hospital

Changhua, 50006, Taiwan

RECRUITING

Chia-Yi Christian Hospital

Chiayi City, 600, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

RECRUITING

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10048, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Soham Staploe Medical Centre

Soham, Cambridgeshire, CB75JD, United Kingdom

RECRUITING

Rowden Surgery

Chippenham, Wiltshire, SN15 2SB, United Kingdom

RECRUITING

Monklands Hospital

Airdrie, ML6 0JS, United Kingdom

RECRUITING

Queen Elizabeth University Hospital Glasgow

Glasgow, G51 4TF, United Kingdom

RECRUITING

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

RECRUITING

Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

RECRUITING

Singleton Hospital

Swansea, SA2 8QA, United Kingdom

RECRUITING

Related Links

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MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WC45725 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 20, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): July 24, 2028
• Study Completion (Estimated): August 28, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (14); GB (8); IT (8); BE (5); NL (2); CZ (6); HU (7); US (36); AU (3); CA (8); AR (7); JP (6); TW (8); FR (9); DE (9); ES (9); PL (10); KR (7); BR (2)