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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
2026-06-23
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 (122)
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
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
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Elevate Clinical Research
Lake Charles, Louisiana, United States
DelRicht Clinical Research, LLC
New Orleans, 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
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 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
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
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
Baker Heart and Diabetes Insitute
Melbourne, Victoria, Australia
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
Diex Recherche Sherbrooke
Sherbrooke, Quebec, Canada
Clinique des maladies lipidiques de Quebec
Québec, Canada
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, China
Peking University People's Hospital
Beijing, China
Beijing Pinggu Hospital
Beijing, China
The Second People's Hospital of Hefei
Hefei, China
Huizhou Central People's Hospital
Huizhou, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China
Shanghai Pudong New Area People's Hospital
Shanghai, China
Shanghai Fifth People's Hospital Affiliated to Fudan University
Shanghai, China
TreDia s.r.o.;Diabetologická ambulance Praha 9
Praha 9 - Klánovice, Czechia
Hopital de la Conception
Marseille, France
CHU de Nice
Nice, France
European Hospital Georges Pompidou (HEGP)
Paris, France
Chu De Tours
Tours, France
InnoDiab Forschung GmbH
Essen, Germany
Medizentrum Essen Borbeck
Essen, Germany
Unterfrintroper Hausarztzentrum
Essen, Germany
Diabeteszentrum Hamburg West
Hamburg, Germany
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie
Hof, Germany
Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung
Pirna, Germany
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Universita Degli Studi Di Perugia
Perugia, Umbria, Italy
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
NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, Poland
ETG Debica
Dębica, Poland
Ekamed sp. z o.o.
Lublin, Poland
NZOZ Eskulap Pabianice
Pabianice, Poland
Centrum Medyczne OMEDICA
Poznan, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki s.c.
Ruda Śląska, Poland
ETG Siedlce
Siedlce, Poland
Panstwowy Instytut Medyczny - MSWiA
Warsaw, Poland
NZOZ Regionalna Poradnia Diabetologiczna
Wroclaw, Poland
FDI Clinical Research
San Juan, Puerto Rico
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruna, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Centro Medico Teknon
Barcelona, Spain
Hospital Gregorio Marañon
Madrid, Spain
Nuevas Tecnologias en Diabetes y Endocrinologia
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
Rajavithi Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
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
Akdeniz University Medical Faculty
Antalya, Turkey (Türkiye)
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool, Lancashire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Antrim Area Hospital
Antrim, United Kingdom
Southmead General Hospital
Bristol, United Kingdom
Ninewells Hospital and Medical School - Tayside Health Board
Dundee, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
HMC Health Group
London, United Kingdom
George Eliot Hospital
Nuneaton, United Kingdom
Knowle House Surgery
Plymouth, United Kingdom