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

NCT07351058 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: WC457262025-523106-32-00
• Study Type: interventional
• Target: 1,600
• Locations: 19 countries
• Sites: 163

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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus; Obesity or Overweight

Outcome Measures

Primary Outcomes (1)

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

  Baseline through Week 72

Secondary Outcomes (40)

• 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

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

  Baseline through Week 72

• Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

  Baseline through 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (163)

Lakeview Clinical Research

Guntersville, Alabama, 35976, United States

RECRUITING

Arizona Clinical Trials

Tucson, Arizona, 85711, United States

RECRUITING

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Ark Clinical Research

Long Beach, California, 90815, United States

RECRUITING

Catalina Research Institute, LLC

Montclair, California, 91763, United States

RECRUITING

Infinity Clinical Research

Norco, California, 92860, United States

RECRUITING

Prospective Research Innovations Inc.

Rancho Cucamonga, California, 91730, United States

RECRUITING

Encompass Clinical Research

Spring Valley, California, 91978, United States

RECRUITING

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20009, United States

RECRUITING

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

RECRUITING

Center for Diabetes, Obesity and Metabolism Inc

Pembroke Pines, Florida, 33024, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

Eirvera, LLC

St. Petersburg, Florida, 33711, United States

RECRUITING

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia, 31904, United States

RECRUITING

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

RECRUITING

Elevate Clinical Research

Lake Charles, Louisiana, 70605, United States

RECRUITING

DelRicht Clinical Research, LLC

New Orleans, Louisiana, 70115, United States

RECRUITING

Centennial Medical Group

Columbia, Maryland, 21045-5840, United States

RECRUITING

Centricity Research Morehead City Multispeciality

Morehead City, North Carolina, 28557, United States

RECRUITING

Remington Davis Inc

Columbus, Ohio, 43215, United States

RECRUITING

Lynn Institute of Norman

Norman, Oklahoma, 73072, United States

RECRUITING

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Essential Medical Research

Tulsa, Oklahoma, 74137, United States

RECRUITING

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

RECRUITING

Circle Clinical Research

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Velocity Clinical Research

Dallas, Texas, 75230, United States

RECRUITING

South Texas Research Institute - Edinburg

Edinburg, Texas, 78539, United States

RECRUITING

HRI ? Medical Center, LLC

Houston, Texas, 77004, United States

RECRUITING

Juno Research, LLC

Houston, Texas, 77040, United States

RECRUITING

HRI ? Pasadena, LLC

Pasadena, Texas, 77505, United States

RECRUITING

DM Clinical Research

Tomball, Texas, 77375, United States

RECRUITING

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

RECRUITING

Centricity Research Suffolk Primary Care

Suffolk, Virginia, 23435, United States

RECRUITING

Era Health Research

Redmond, Washington, 98052, 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

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Logan Hospital

Meadowbrook, Queensland, 4131, 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

Centricity Research Calgary Endocrinology

Calgary, Alberta, T2H 2G4, Canada

RECRUITING

TGElliott Inc. dba BC Diabetes

Vancouver, British Columbia, V5Y 3W2, Canada

RECRUITING

Centricity Research Brampton Endocrinology

Brampton, Ontario, L6S 0C6, Canada

RECRUITING

Medicor Research Inc

Greater Sudbury, Ontario, P3C 1X3, Canada

RECRUITING

LMC Clinical Research Inc

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Diex Recherche Sherbrooke

Sherbrooke, Quebec, J1L 0H8, Canada

RECRUITING

Clinique des maladies lipidiques de Quebec

Québec, G1V 4W2, Canada

RECRUITING

Huai He Hospital of Henan University

Kaifeng, Henan, 475001, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

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

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, 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

Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, 210008, China

RECRUITING

Pingxiang People's Hospital

Pingxiang, 337000, China

RECRUITING

Shanghai Pudong New Area People's Hospital

Shanghai, 201299, China

RECRUITING

Shanghai Fifth People's Hospital Affiliated to Fudan University

Shanghai, 201304, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, 215333, China

RECRUITING

Wuxi People's Hospital

Wuxi, 214023, China

RECRUITING

DIACENTRUM Brandýs nad Labem s.r.o.

Brandýs nad Labem, 25001, Czechia

RECRUITING

Diavital Jesenice s.r.o.

Jesenice, 25242, Czechia

RECRUITING

FLEDIP s.r.o.

Prague, 160 00, Czechia

RECRUITING

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

Praha 9 - Klánovice, 19014, Czechia

RECRUITING

Hopital Saint Joseph Saint Luc

Lyon, 69007, France

RECRUITING

Hopital de la Conception

Marseille, 13000, France

RECRUITING

CHU de Nice

Nice, 06602, France

RECRUITING

European Hospital Georges Pompidou (HEGP)

Paris, 75908, France

RECRUITING

Chu De Tours

Tours, 37000, 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

Universitaets Klinikum Frankfurt - Zentrum der Inneren Medizin

Frankfurt, 60596, Germany

NOT YET 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

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

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, 00161, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Sicily, 90127, Italy

RECRUITING

AO di Perugia - Ospedale S. Maria della Misericordia

Perugia, Umbria, 06156, 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

Arechavaleta Granell Maria del Rosario

Guadalajara, Jalisco, 44650, Mexico

RECRUITING

Clinicos Asociados Bocm, S.C.

México, Mexico CITY (federal District), 03300, Mexico

RECRUITING

Avant Santé Research Center

San Pedro Garza García, Nuevo León, 66260, Mexico

RECRUITING

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

Bialystok, Podlaskie Voivodeship, 15-351, Poland

RECRUITING

Centrum Medyczne INTERCOR Sp. z o.o.

Bydgoszcz, 85-605, Poland

RECRUITING

ETG Debica

Dębica, 39-200, Poland

RECRUITING

Ekamed sp. z o.o.

Lublin, 20-718, Poland

RECRUITING

NZOZ Eskulap Pabianice

Pabianice, 95-200, Poland

RECRUITING

Centrum Medyczne OMEDICA

Poznan, 60-111, Poland

RECRUITING

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

Ruda Śląska, 41-709, Poland

RECRUITING

ETG Siedlce

Siedlce, 08-110, Poland

RECRUITING

Panstwowy Instytut Medyczny - MSWiA

Warsaw, 02-507, Poland

RECRUITING

NZOZ Regionalna Poradnia Diabetologiczna

Wroclaw, 50-127, Poland

RECRUITING

FDI Clinical Research

San Juan, 00927, Puerto Rico

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, 13620, South Korea

RECRUITING

Yonsei University Wonju Severance Christian Hospital

Gangwon-do, 26426, South Korea

RECRUITING

Chosun University Hospital

Gwangju, 61453, South Korea

RECRUITING

Eulji General Hospital

Seoul, 01830, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruna, 15006, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Centro Medico Teknon

Barcelona, 08022, Spain

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz.

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Nuevas Tecnologias en Diabetes y Endocrinologia

Seville, 41003, 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

Rajavithi Hospital

Bangkok, 10400, Thailand

RECRUITING

Ramathibodi Hospital

Bangkok, 10400, Thailand

RECRUITING

Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Division of Endocrinology and Metabolism;Internal Medicine

Chiang Mai, 50200, Thailand

RECRUITING

Songklanagarind Hospital

Hat Yai, 90110, Thailand

RECRUITING

Thammasat University Hospital

Khlong Luang, 12120, Thailand

RECRUITING

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Akdeniz University Medical Faculty

Antalya, 07059, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University Medicine Faculty

Izmir, 35340, Turkey (Türkiye)

RECRUITING

Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi

Sariçam, 01250, Turkey (Türkiye)

RECRUITING

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool, Lancashire, FY3 7EN, United Kingdom

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, AB9 2ZB, United Kingdom

RECRUITING

Antrim Area Hospital

Antrim, BT41 2RL, United Kingdom

RECRUITING

Southmead General Hospital

Bristol, BS10 5NB, United Kingdom

RECRUITING

Ninewells Hospital and Medical School - Tayside Health Board

Dundee, DD1 9SY, United Kingdom

RECRUITING

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

RECRUITING

HMC Health Group

London, TW47NR, United Kingdom

RECRUITING

George Eliot Hospital

Nuneaton, CV10 7DJ, United Kingdom

RECRUITING

Knowle House Surgery

Plymouth, PL5 3JB, United Kingdom

RECRUITING

Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

RECRUITING

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WC45726 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 23, 2026
• Primary Completion (Estimated): August 7, 2028
• Study Completion (Estimated): August 7, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (35); ES (9); TU (4); DE (10); IT (7); PL (10); CN (20); FR (5); CZ (4); GB (10); TW (8); AR (7); CA (7); AU (5); JP (6); TH (6); PR (1); ME (3); KR (6)