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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Sponsor: Hoffmann-La Roche
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
2026-10-13
Healthy Volunteers
No
Interventions
Placebo
Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
Enicepatide
Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
Locations (210)
Lakeview Clinical Research
Guntersville, Alabama, United States
Arizona Clinical Trials
Tucson, Arizona, United States
University of California Irvine
Irvine, California, 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
Infinity Clinical Research
Norco, 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
Atlanta Veterans Affairs Medical Center
Decatur, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Central Illinois Diabetes and Clinical Research
Springfield, Illinois, United States
Elevate Clinical Research
Lake Charles, Louisiana, United States
Nola Care Clinical Research Center
Metairie, Louisiana, United States
DelRicht Clinical Research, LLC
New Orleans, Louisiana, United States
Centennial Medical Group
Columbia, Maryland, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Centricity Research Morehead City Multispeciality
Morehead City, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Remington Davis Inc
Columbus, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Essential Medical Research
Tulsa, Oklahoma, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Circle Clinical Research
Sioux Falls, South Dakota, United States
Headlands Research Brownsville
Brownsville, Texas, United States
Velocity Clinical Research
Dallas, Texas, United States
South Texas Research Institute - Edinburg
Edinburg, Texas, United States
HRI ? Medical Center, LLC
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
HRI ? Pasadena, LLC
Pasadena, Texas, United States
Pinnacle Clinical Research - San Antonio
San Antonio, 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
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Logan Hospital
Meadowbrook, Queensland, Australia
Southern Adelaide Diabetes and Endocrine Services (SADES)
Oaklands Park, South Australia, Australia
Heidelberg Repatriation Hospital
Heidelberg, Victoria, Australia
Baker Heart and Diabetes Insitute
Melbourne, Victoria, Australia
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre, Rio Grande do Sul, Brazil
Clinica do Coracao
Aracaju, Sergipe, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, Brazil
Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
IBPCLIN Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, Brazil
Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada
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
Applied Medical Informatics Research Inc. (A.M.I.R.)
Montreal, Quebec, Canada
Diex Recherche Sherbrooke East
Sherbrooke, Quebec, Canada
Clinique des maladies lipidiques de Quebec
Québec, Canada
Cangzhou People's Hospital
Cangzhou, Hebei, China
Huai He Hospital of Henan University
Kaifeng, Henan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Peking University People's Hospital
Beijing, China
Beijing Pinggu Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
The Second People's Hospital of Hefei
Hefei, China
The Fourth Affiliated Hospital of Harbin Medical University
Herbin, China
Huizhou Central People's Hospital
Huizhou, China
Hebei Petro China Central Hospital
Langfang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, China
Pingxiang People's Hospital
Pingxiang, China
Shanghai Pudong New Area People's Hospital
Shanghai, China
Shanghai Fifth People's Hospital Affiliated to Fudan University
Shanghai, China
Siping Central People's Hospital
Siping, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Wuxi People's Hospital
Wuxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, China
Yueyang Central Hospital
Yueyang, China
DIACENTRUM Brandýs nad Labem s.r.o.
Brandýs nad Labem, Czechia