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RECRUITING

NCT07351045

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-03-16

Completion Date

2028-08-28

Last Updated

2026-05-26

Healthy Volunteers

Conditions

Obesity or Overweight

Interventions

COMBINATION_PRODUCT

Placebo

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

COMBINATION_PRODUCT

Enicepatide

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

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

Locations (58)

Pinnacle Research Group

Anniston, Alabama, United States

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Arizona Clinical Trials

Tucson, Arizona, United States

Artemis Institute for Clinical Research, LLC

San Diego, California, 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

Monroe Biomedical Research

Louisville, Kentucky, United States

Knownwell

Needham, Massachusetts, United States

International Diabetes Center At Park Nicollet

Minneapolis, Minnesota, 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

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

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

Dallas, Texas, United States

Elevate Clinical

Houston, Texas, United States

Elevate Clinical

McAllen, 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

Baker Heart and Diabetes Insitute

Melbourne, Victoria, Australia

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

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

Pessac, France

InnoDiab Forschung GmbH

Essen, Germany

Medizentrum Essen Borbeck

Essen, Germany

Unterfrintroper Hausarztzentrum

Essen, Germany

Kasugai Municipal Hospital

Aichi, Japan

Fukuhama Chuo Clinic

Fukuoka, Japan

NTT Medical Center Sapporo

Hokkaido, Japan

Hasegawa Medicine Clinic

Hokkaido, Japan

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, Japan

Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman

Gdynia, Poland

ETG Warszawa

Warsaw, Poland

Hospital Vithas Sevilla

Seville, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (58)