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RECRUITING

NCT07351058

PHASE3

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and 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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

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 and Type 2 Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2026-03-23

Completion Date

2028-08-07

Last Updated

2026-05-26

Healthy Volunteers

Conditions

Obesity or Overweight Type 2 Diabetes Mellitus

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: * 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 Exclusion Criteria: * 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

Locations (61)

Lakeview Clinical Research

Guntersville, Alabama, United States

Arizona Clinical Trials

Tucson, Arizona, United States

Orange County Research Center

Lake Forest, California, United States

Ark Clinical Research

Long Beach, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Prospective Research Innovations Inc.

Rancho Cucamonga, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Emerson Clinical Research Institute

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

Tampa Bay Medical Research, Inc.

Clearwater, Florida, United States

Center for Diabetes, Obesity and Metabolism Inc

Pembroke Pines, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Eirvera, LLC

St. Petersburg, Florida, United States

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Elevate Clinical Research

Lake Charles, Louisiana, United States

Centennial Medical Group

Columbia, Maryland, United States

Centricity Research Morehead City Multispeciality

Morehead City, North Carolina, United States

Remington Davis Inc

Columbus, Ohio, United States

Essential Medical Research

Tulsa, Oklahoma, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Circle Clinical Research

Sioux Falls, South Dakota, United States

Velocity Clinical Research

Dallas, Texas, United States

Juno Research, LLC

Houston, Texas, United States

HRI ? Pasadena, LLC

Pasadena, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Centricity Research Suffolk Primary Care

Suffolk, Virginia, United States

Era Health Research

Redmond, Washington, 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

Logan Hospital

Meadowbrook, Queensland, Australia

Baker Heart and Diabetes Insitute

Melbourne, Victoria, Australia

TGElliott Inc. dba BC Diabetes

Vancouver, British Columbia, Canada

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Medicor Research Inc

Greater Sudbury, Ontario, Canada

LMC Clinical Research Inc

Toronto, Ontario, Canada

Clinique des maladies lipidiques de Quebec

Québec, Canada

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

FDI Clinical Research

San Juan, Puerto Rico

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

Siriraj Hospital

Bangkok, Thailand

Division of Endocrinology and Metabolism;Internal Medicine

Chiang Mai, Thailand

Songklanagarind Hospital

Hat Yai, Thailand

Thammasat University Hospital

Khlong Luang, Thailand

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (61)