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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
2026-08-14
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 (193)
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
Elite Clinical Trials
Blackfoot, Idaho, 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
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
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, Brazil
Centro de Pesquisas Clinicas
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
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
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
DIACENTRUM Brandýs nad Labem s.r.o.
Brandýs nad Labem, Czechia
Diavital Jesenice s.r.o.
Jesenice, Czechia
FLEDIP s.r.o.
Prague, Czechia
TreDia s.r.o.;Diabetologická ambulance Praha 9
Praha 9 - Klánovice, Czechia
Hopital Saint Joseph Saint Luc
Lyon, France
Hopital de la Conception
Marseille, France
CHU de Nice
Nice, France
European Hospital Georges Pompidou (HEGP)
Paris, France
Chu De Tours
Tours, France
Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum Medizinische Fakultät OWL (Universität Bielefeld);Klinik für Diabetologie und Endokrinologie
Bad Oeynhausen, Germany
Hector-Center für Ernährung, Bewegung und Sport, Universitätsklinikum Erlangen;Medizinische Klinik 1 ? Gastroenterologie, Pneumologie und Endokrinologie
Erlangen, Germany
InnoDiab Forschung GmbH
Essen, Germany
Medizentrum Essen Borbeck
Essen, Germany
Unterfrintroper Hausarztzentrum
Essen, Germany
Universitaets Klinikum Frankfurt - Zentrum der Inneren Medizin
Frankfurt, Germany
MVZ Diabeteszentrum Dr. Tews GmbH;Praxis für Diabetologie
Gelnhausen, Germany
Diabeteszentrum Hamburg West
Hamburg, Germany
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie
Hof, Germany
Zentrum für klinische Forschung Köln - Dünnwald;Dünnwald Praxis
Köln - Dünnwald, Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Dr. med. Winfried Keuthage
Münster, Germany
Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung
Pirna, Germany
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Abruzzo, Italy
Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro
Catanzaro, Calabria, Italy
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
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy
AO di Perugia - Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
Kasugai Municipal Hospital
Aichi, Japan
Fukuhama Chuo Clinic
Fukuoka, Japan
NTT Medical Center Sapporo
Hokkaido, Japan
Hasegawa Medicine Clinic
Hokkaido, Japan
The University of Osaka Hospital
Osaka, Japan
Higashijujo Sakai Diabetes Internal Medicine Clinic
Tokyo, Japan
Medical Center Metas SC
Col Saucito, Chihuahua, Mexico
Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, Mexico
Instituto Jalisciense de investigacion en diabetes y obesidad S.C.
Guadalajara, Jalisco, Mexico
CEMDEC S.A. de C.V.
Delegacion Cuauhtemoc, Mexico CITY (federal District), Mexico
Clinicos Asociados Bocm, S.C.
México, Mexico CITY (federal District), Mexico
Instittuto Nacional de Ciencias Medicas y Nutricion "Salvador Subiran"
México, Mexico CITY (federal District), Mexico
Instituto de Diabetes Obesidad y Nutricion, SC
Cuernavaca, Morelos, Mexico
Avant Santé Research Center
San Pedro Garza García, Nuevo León, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares SC
Ciudad Madero, Tamaulipas, Mexico
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
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, South Korea
Chosun University Hospital
Gwangju, South Korea
Uijeongbu St. Mary's Hospital
Gyeonggi-do, South Korea
Eulji General Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Gangdong Kyung Hee University Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruna, Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, LA Coruna, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Centro Medico Teknon
Barcelona, Spain
Hospital Universitari Vall d Hebron
Barcelona, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 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
Koc University Medical Faculty Hospital
Istanbul, Zeytinburnu, Turkey (Türkiye)
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, Turkey (Türkiye)
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey (Türkiye)
Medeniyet University Goztepe Training and Research Hospital
Istanbul, Turkey (Türkiye)
Dokuz Eylul University Medicine Faculty
Izmir, Turkey (Türkiye)
Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi
Sariçam, 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
Musgrove Park Hospital
Taunton, United Kingdom