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
Status: Recruiting
Location: See all (61) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Lakeview Clinical Research
RECRUITING
Guntersville
Arizona
Arizona Clinical Trials
RECRUITING
Tucson
California
Orange County Research Center
RECRUITING
Lake Forest
Ark Clinical Research
RECRUITING
Long Beach
Catalina Research Institute, LLC
RECRUITING
Montclair
Prospective Research Innovations Inc.
RECRUITING
Rancho Cucamonga
Encompass Clinical Research
RECRUITING
Spring Valley
Washington, D.c.
Emerson Clinical Research Institute
RECRUITING
Washington D.c.
Florida
Tampa Bay Medical Research, Inc.
RECRUITING
Clearwater
Center for Diabetes, Obesity and Metabolism Inc
RECRUITING
Pembroke Pines
Progressive Medical Research
RECRUITING
Port Orange
Eirvera, LLC
RECRUITING
St. Petersburg
Georgia
Centricity Research Columbus Georgia Multispecialty
RECRUITING
Columbus
Rophe Adult and Pediatric Medicine/SKYCRNG
RECRUITING
Union City
Louisiana
Elevate Clinical Research
RECRUITING
Lake Charles
Maryland
Centennial Medical Group
RECRUITING
Columbia
North Carolina
Centricity Research Morehead City Multispeciality
RECRUITING
Morehead City
Ohio
Remington Davis Inc
RECRUITING
Columbus
Oklahoma
Essential Medical Research
RECRUITING
Tulsa
South Carolina
Coastal Carolina Research Center
RECRUITING
North Charleston
South Dakota
Circle Clinical Research
RECRUITING
Sioux Falls
Texas
Velocity Clinical Research
RECRUITING
Dallas
Juno Research, LLC
RECRUITING
Houston
HRI ? Pasadena, LLC
RECRUITING
Pasadena
DM Clinical Research
RECRUITING
Tomball
Virginia
Manassas Clinical Research Center
RECRUITING
Manassas
Centricity Research Suffolk Primary Care
RECRUITING
Suffolk
Washington
Era Health Research
RECRUITING
Redmond
Other Locations
Argentina
CEDIC Centro de Investigaciones Clinicas
RECRUITING
Buenos Aires
Centro Medico Viamonte SRL
RECRUITING
Buenos Aires
CINME
RECRUITING
Buenos Aires
IME - Instituto Médico Especializado
RECRUITING
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
RECRUITING
Ciudad Autonoma Buenos Aires
Instituto centenario
RECRUITING
Ciudad Autonoma Buenos Aires
Centro de Investigaciones Medicas Mar Del Plata
RECRUITING
Mar Del Plata
Australia
Paratus Clinical Western Sydney
RECRUITING
Blacktown
Logan Hospital
RECRUITING
Meadowbrook
Baker Heart and Diabetes Insitute
RECRUITING
Melbourne
Canada
Centricity Research Brampton Endocrinology
RECRUITING
Brampton
Medicor Research Inc
RECRUITING
Greater Sudbury
Clinique des maladies lipidiques de Quebec
RECRUITING
Québec
LMC Clinical Research Inc
RECRUITING
Toronto
TGElliott Inc. dba BC Diabetes
RECRUITING
Vancouver
Japan
Kasugai Municipal Hospital
RECRUITING
Aichi
Fukuhama Chuo Clinic
RECRUITING
Fukuoka
Hasegawa Medicine Clinic
RECRUITING
Hokkaido
NTT Medical Center Sapporo
RECRUITING
Hokkaido
Higashijujo Sakai Diabetes Internal Medicine Clinic
RECRUITING
Tokyo
Puerto Rico
FDI Clinical Research
RECRUITING
San Juan
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Chia-Yi Christian Hospital
RECRUITING
Chiayi City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
Chung Shan Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Thailand
Siriraj Hospital
RECRUITING
Bangkok
Division of Endocrinology and Metabolism;Internal Medicine
RECRUITING
Chiang Mai
Songklanagarind Hospital
RECRUITING
Hat Yai
Thammasat University Hospital
RECRUITING
Khlong Luang
Contact Information
Primary
Reference Study ID Number: WC45726 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Backup
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2028-08-07
Participants
Target number of participants: 1600
Treatments
Placebo_comparator: Arm 1: Placebo
Experimental: Arm 2: Enicepatide Dosing Regimen 1
Experimental: Arm 3: Enicepatide Dosing Regimen 2
Experimental: Arm 4: Enicepatide Dosing Regimen 3
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche