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
Status: Recruiting
Location: See all (189) 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have at screening:
‣ Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
⁃ BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
• History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
• Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Locations
United States
Alabama
Pinnacle Research Group
RECRUITING
Anniston
Alabama Clinical Therapeutics
RECRUITING
Birmingham
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Arizona Clinical Trials
RECRUITING
Tucson
California
Artemis Institute for Clinical Research, LLC
RECRUITING
San Diego
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Connecticut
Yale University
RECRUITING
New Haven
Georgia
Rophe Adult and Pediatric Medicine/SKYCRNG
RECRUITING
Union City
Hawaii
East-West Medical Research Institute
RECRUITING
Honolulu
Illinois
Elevate Clinical Research
RECRUITING
Gurnee
Knownwell
RECRUITING
Schaumburg
Endeavor Health
RECRUITING
Skokie
Kentucky
Monroe Biomedical Research
RECRUITING
Louisville
Louisiana
Ascension DePaul Health
RECRUITING
New Orleans
Massachusetts
Boston Medical Center
RECRUITING
Boston
Knownwell
RECRUITING
Needham
Minnesota
International Diabetes Center At Park Nicollet
RECRUITING
Minneapolis
Missouri
Clinvest Research LLC
RECRUITING
Springfield
Mississippi
DelRicht Research at Gulfport Memorial
RECRUITING
Gulfport
New York
Rochester Clinical Research
RECRUITING
Buffalo
Ohio
Hometown Urgent Care and Research - Dayton
RECRUITING
Dayton
Oklahoma
Delricht Research of Tulsa Clinical Trials
RECRUITING
Tulsa
Oregon
Headlands Reseach- Summit
RECRUITING
Portland
Pennsylvania
Suburban Research Associates - West Chester Office
RECRUITING
West Chester
South Carolina
Trial Management Associates
RECRUITING
Myrtle Beach
South Dakota
Circle Clinical Research
RECRUITING
Sioux Falls
Tennessee
Innovative Clinical Research
RECRUITING
Clarksville
Clinical Research Associates
RECRUITING
Nashville
Texas
Bellaire Clinical Research, LLC
RECRUITING
Bellaire
South Texas Research Institute - Brownsville
RECRUITING
Brownsville
South Texas Clinical Research
RECRUITING
Corpus Christi
University of Texas Southwestern Medical Center - Children's Medical Center Dallas
RECRUITING
Dallas
Elevate Clinical
RECRUITING
Houston
Houston Research Institute
RECRUITING
Houston
Elevate Clinical
RECRUITING
Mcallen
IMA Clinical Research - San Antonio
RECRUITING
San Antonio
Pinnacle Clinical Research - South San Antonio
RECRUITING
San Antonio
Consano Clinical Research
RECRUITING
Shavano Park
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
RECRUITING
Southlake
Utah
George E. Wahlen Department of Veterans Affairs Medical Center
RECRUITING
Salt Lake City
Wisconsin
Ascension Columbia St. Mary's
RECRUITING
Milwaukee
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
Heidelberg Repatriation Hospital
RECRUITING
Heidelberg
Baker Heart and Diabetes Insitute
RECRUITING
Melbourne
Southern Adelaide Diabetes and Endocrine Services (SADES)
RECRUITING
Oaklands Park
Royal North Shore Hospital
RECRUITING
St Leonards
Belgium
AZORG Campus Aalst-Moorselbaan
RECRUITING
Aalst
Hospital Erasme
RECRUITING
Brussels
UZ Leuven Gasthuisberg
RECRUITING
Leuven
CHU de Liège (Sart Tilman)
RECRUITING
Liège
AZ Delta (Campus Rumbeke)
RECRUITING
Roeselare
Brazil
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
RECRUITING
Goiânia
Hospital Universitário Onofre Lopes - UFRN
RECRUITING
Natal
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
RECRUITING
Porto Alegre
Hospital de Base de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
BR Trials - Pesquisa Clínica
RECRUITING
São Paulo
Centro de Pesquisas Clinicas
RECRUITING
São Paulo
CPQuali Pesquisa Clinica Ltda
RECRUITING
São Paulo
Canada
Aggarwal and Associates
RECRUITING
Brampton
C-health Partners Inc
RECRUITING
Calgary
Hamilton Medical Research Group
RECRUITING
Hamilton
Wharton Medical Clinic
RECRUITING
Hamilton
Alpha Recherche Clinique
RECRUITING
Québec
Bluewater Clinical Research Group
RECRUITING
Sarnia
Unity Healthcare Clinic
RECRUITING
Surrey
Diex Recherche Trois-Rivieres
RECRUITING
Trois-rivières
China
Beijing Pinggu Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
The Second People's Hospital of Hefei
RECRUITING
Hefei
Huizhou Central People's Hospital
RECRUITING
Huizhou
Jinan Central Hospital
RECRUITING
Jinan
Hebei Petro China Central Hospital
RECRUITING
Langfang
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Pingxiang People's Hospital
RECRUITING
Pingxiang
Shanghai Pudong New Area People's Hospital
RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Yan'an University Xianyang Hospital
RECRUITING
Xianyang
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
France
CHU d'Angers
RECRUITING
Angers
CHU de Rouen - HOPITAL Bois Guillaume
RECRUITING
Bois-guillaume
CHU Dijon - Hopital Francois Mitterrand
RECRUITING
Dijon
Groupe Hospitalier Pitié Salpétrière;Service d?endocrinologie, diabétologie et nutrition
RECRUITING
Paris
Hopital Européen Georges Pompidou;Service d?endocrinologie, diabétologie et nutrition
RECRUITING
Paris
CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutrition
RECRUITING
Pessac
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
CHU DE POITIERS - Hôpital de la Milétrie
RECRUITING
Poitiers
CHU de Nantes - Hopital Laennec
RECRUITING
Saint-herblain
Germany
Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum Medizinische Fakultät OWL (Universität Bielefeld);Klinik für Diabetologie und Endokrinologie
RECRUITING
Bad Oeynhausen
Hector-Center für Ernährung, Bewegung und Sport, Universitätsklinikum Erlangen;Medizinische Klinik 1 ? Gastroenterologie, Pneumologie und Endokrinologie
RECRUITING
Erlangen
InnoDiab Forschung GmbH
RECRUITING
Essen
Medizentrum Essen Borbeck
RECRUITING
Essen
Unterfrintroper Hausarztzentrum
RECRUITING
Essen
Universitaets Klinikum Frankfurt - Zentrum der Inneren Medizin
RECRUITING
Frankfurt
Diabeteszentrum Hamburg West
RECRUITING
Hamburg
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie
RECRUITING
Hof
Zentrum für klinische Forschung Köln - Dünnwald;Dünnwald Praxis
RECRUITING
Köln - Dünnwald
Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Dr. med. Winfried Keuthage
RECRUITING
Münster
Diabetologische Schwerpunktpraxis Pirna Hausärztliche Versorgung
RECRUITING
Pirna
Hungary
DRC Gyogyszervizsgalo Kozpont Kft
RECRUITING
Balatonfüred
Anyagcsere Centrum Csepel/Szatmári-Med Kft.;Diabetology
RECRUITING
Budapest
MED-TIMA Kft.
RECRUITING
Budapest
Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika
RECRUITING
Budapest
Debreceni Egyetem, Klinikai Kozpont;Belgyogyaszati Klinika, A epulet
RECRUITING
Debrecen
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont;Belgyogyaszati Klinika
RECRUITING
Szeged
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz;2nd Department of Internal Medicine, Nephrological and Diabetological Center
RECRUITING
Székesfehérvár
Italy
Azienda Ospedaliera Papa Giovanni XXIII
RECRUITING
Bergamo
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
RECRUITING
Bologna
Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro
RECRUITING
Catanzaro
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
RECRUITING
Palermo
Universita Degli Studi Di Perugia
RECRUITING
Perugia
Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
I.R.C.C.S Policlinico San Donato
RECRUITING
San Donato Milanese (mi)
Japan
Kasugai Municipal Hospital
RECRUITING
Aichi
Fukuhama Chuo Clinic
RECRUITING
Fukuoka
Hasegawa Medicine Clinic
RECRUITING
Hokkaido
NTT Medical Center Sapporo
RECRUITING
Hokkaido
The University of Osaka Hospital
RECRUITING
Osaka
Higashijujo Sakai Diabetes Internal Medicine Clinic
RECRUITING
Tokyo
Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares SC
RECRUITING
Ciudad Madero
Medical Center Metas SC
RECRUITING
Col Saucito
Instituto de Diabetes, Obesidad y Nutricion S.C. Coordinacion
RECRUITING
Cuernavaca
CEMDEC S.A. de C.V.
RECRUITING
Delegacion Cuauhtemoc
Arechavaleta Granell Maria del Rosario
RECRUITING
Guadalajara
Instituto Jalisciense de investigacion en diabetes y obesidad S.C.
RECRUITING
Guadalajara
Clinicos Asociados Bocm, S.C.
RECRUITING
México
Instittuto Nacional de Ciencias Medicas y Nutricion Salvador Subiran
RECRUITING
México
Avant Santé Research Center
RECRUITING
San Pedro Garza García
Netherlands
Amsterdam UMC Location AMC
RECRUITING
Amsterdam
Radboud Universitair Medisch Centrum
RECRUITING
Nijmegen
Erasmus MC
RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Isala
RECRUITING
Zwolle
Poland
NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny
RECRUITING
Bialystok
Centrum Medyczne Kermed Renata Bijata-Bronisz i Ewa Kowali?ska Sp.j.
RECRUITING
Bydgoszcz
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Cymerman
RECRUITING
Gdynia
Centrum Medyczne ALL-MED
RECRUITING
Krakow
Gabinety Medyczne MATUSZEK
RECRUITING
Lublin
Centrum Medyczne Clinicly
RECRUITING
Opole
Osrodek Badan Klinicznych Metabolica
RECRUITING
Tarnów
Polsko-Amerykanskie Kliniki Serca;X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji
RECRUITING
Tychy
ETG Warszawa
RECRUITING
Warsaw
ETG Zamosc
RECRUITING
Zamo??
Republic of Korea
Kyungpook National University Hospital
RECRUITING
Daegu
Konyang University Hospital
RECRUITING
Daejeon
Chosun University Hospital
RECRUITING
Gwangju
Bucheon St Mary's hospital
RECRUITING
Gyeonggi-do
Hanyang University Guri Hospital
RECRUITING
Gyeonggi-do
Gachon University Gil Medical Center
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hospital San Rafael A Coruna
RECRUITING
A Coruña
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Vall d Hebron
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Ruber Juan Bravo
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Quironsalud Infanta Luisa
RECRUITING
Seville
Hospital Vithas Sevilla
RECRUITING
Seville
Hospital Universitari i Politècnic La Fe
RECRUITING
Valencia
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
United Kingdom
Monklands Hospital
RECRUITING
Airdrie
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Rowden Surgery
RECRUITING
Chippenham
Queen Elizabeth University Hospital Glasgow
RECRUITING
Glasgow
Leicester General Hospital
RECRUITING
Leicester
Hammersmith Hospital
RECRUITING
London
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Soham Staploe Medical Centre
RECRUITING
Soham
Singleton Hospital
RECRUITING
Swansea
Contact Information
Primary
Reference Study ID Number: WC45725 https://forpatients.roche.com/ No attachments to email below.
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Backup
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Time Frame
Start Date: 2026-03-16
Estimated Completion Date: 2028-08-28
Participants
Target number of participants: 2000
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