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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
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 Without Type 2 Diabetes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2026-03-16
Completion Date
2028-08-28
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
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 (195)
Pinnacle Research Group
Anniston, Alabama, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Clinical Trials
Tucson, Arizona, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Yale University
New Haven, Connecticut, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Elevate Clinical Research
Gurnee, Illinois, United States
Knownwell
Schaumburg, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Monroe Biomedical Research
Louisville, Kentucky, United States
Ascension DePaul Health
New Orleans, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
Knownwell
Needham, Massachusetts, United States
International Diabetes Center At Park Nicollet
Minneapolis, Minnesota, United States
DelRicht Research at Gulfport Memorial
Gulfport, Mississippi, United States
Clinvest Research LLC
Springfield, Missouri, United States
Rochester Clinical Research
Buffalo, New York, United States
Hometown Urgent Care and Research - Dayton
Dayton, Ohio, United States
Delricht Research of Tulsa Clinical Trials
Tulsa, Oklahoma, United States
Headlands Reseach- Summit
Portland, Oregon, United States
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, United States
Trial Management Associates
Myrtle Beach, South Carolina, United States
Circle Clinical Research
Sioux Falls, South Dakota, United States
Innovative Clinical Research
Clarksville, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
Bellaire Clinical Research, LLC
Bellaire, Texas, United States
South Texas Research Institute - Brownsville
Brownsville, Texas, United States
South Texas Clinical Research
Corpus Christi, Texas, United States
University of Texas Southwestern Medical Center - Children's Medical Center Dallas
Dallas, Texas, United States
Elevate Clinical
Houston, Texas, United States
Houston Research Institute
Houston, Texas, United States
Elevate Clinical
McAllen, Texas, United States
Pinnacle Clinical Research - South San Antonio
San Antonio, Texas, United States
IMA Clinical Research - San Antonio
San Antonio, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Southlake, Texas, United States
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, United States
Ascension Columbia St. Mary's
Milwaukee, Wisconsin, 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 North Shore Hospital
St Leonards, New South Wales, 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
AZORG Campus Aalst-Moorselbaan
Aalst, Belgium
Hospital Erasme
Brussels, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
CHU de Liège (Sart Tilman)
Liège, Belgium
AZ Delta (Campus Rumbeke)
Roeselare, Belgium
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás, Brazil
Hospital Universitário Onofre Lopes - UFRN
Natal, Rio Grande do Norte, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre, Rio Grande do Sul, 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
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, Brazil
C-health Partners Inc
Calgary, Alberta, Canada
Unity Healthcare Clinic
Surrey, British Columbia, Canada
Aggarwal and Associates
Brampton, Ontario, Canada
Hamilton Medical Research Group
Hamilton, Ontario, Canada
Wharton Medical Clinic
Hamilton, Ontario, Canada
Bluewater Clinical Research Group
Sarnia, Ontario, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
Alpha Recherche Clinique
Québec, Canada
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, 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
Pingxiang People's Hospital
Pingxiang, China
Shanghai Pudong New Area People's Hospital
Shanghai, China
The First Affiliated Hospital of Soochow University
Suzhou, China
MUDr. Alena Váchová, Diabetologie
České Budějovice, Czechia
Edumed s.r.o.;Diabetologická ambulance
Náchod, Czechia
DIALINE s.r.o.
Plze?, Czechia
MediSpo Clinic
Prague, Czechia
DiaVize
Prague, Czechia
MEDICON a.s. - Poliklinika Bud?jovická
Prague, Czechia
CHU d'Angers
Angers, France
CHU de Rouen - HOPITAL Bois Guillaume
Bois-Guillaume, France
CHU Dijon - Hopital Francois Mitterrand
Dijon, France
Hopital Européen Georges Pompidou;Service d?endocrinologie, diabétologie et nutrition
Paris, France
Groupe Hospitalier Pitié Salpétrière;Service d?endocrinologie, diabétologie et nutrition
Paris, France
CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutrition
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHU DE POITIERS - Hôpital de la Milétrie
Poitiers, France
CHU de Nantes - Hopital Laennec
Saint-Herblain, 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
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
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, Hungary
Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika
Budapest, Hungary
MED-TIMA Kft.
Budapest, Hungary
Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology
Budapest, Hungary
Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet
Debrecen, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika
Szeged, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz;2nd Department of Internal Medicine, Nephrological and Diabetological Center
Székesfehérvár, Hungary
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
Pisa, Tuscany, 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
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 S.C. Coordinacion
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
Amsterdam UMC Location AMC
Amsterdam, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Isala
Zwolle, Netherlands
NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz i Ewa Kowali?ska Sp.j.
Bydgoszcz, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman
Gdynia, Poland
Centrum Medyczne ALL-MED
Krakow, Poland
Gabinety Medyczne MATUSZEK
Lublin, Poland
Centrum Medyczne Clinicly
Opole, Poland
Osrodek Badan Klinicznych Metabolica
Tarnów, Poland
Polsko-Amerykanskie Kliniki Serca;X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji
Tychy, Poland
ETG Warszawa
Warsaw, Poland
ETG Zamosc
Zamo??, Poland
Kyungpook National University Hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Konyang University Hospital
Daejeon, South Korea
Chosun University Hospital
Gwangju, South Korea
Hanyang University Guri Hospital
Gyeonggi-do, South Korea
Bucheon St Mary's hospital
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital San Rafael A Coruna
A Coruña, LA Coruna, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall d Hebron
Barcelona, Spain
Hospital Ruber Juan Bravo
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Quironsalud Infanta Luisa
Seville, Spain
Hospital Vithas Sevilla
Seville, Spain
Hospital Universitari i Politècnic La Fe
Valencia, 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
Soham Staploe Medical Centre
Soham, Cambridgeshire, United Kingdom
Rowden Surgery
Chippenham, Wiltshire, United Kingdom
Monklands Hospital
Airdrie, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Queen Elizabeth University Hospital Glasgow
Glasgow, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
Hammersmith Hospital
London, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Singleton Hospital
Swansea, United Kingdom