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 (72) 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
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
Kentucky
Monroe Biomedical Research
RECRUITING
Louisville
Massachusetts
Knownwell
RECRUITING
Needham
Minnesota
International Diabetes Center At Park Nicollet
RECRUITING
Minneapolis
Missouri
Clinvest Research LLC
RECRUITING
Springfield
New York
Rochester Clinical Research
RECRUITING
Buffalo
Ohio
Hometown Urgent Care and Research - Dayton
RECRUITING
Dayton
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
University of Texas Southwestern Medical Center - Children's Medical Center Dallas
RECRUITING
Dallas
Elevate Clinical
RECRUITING
Houston
Elevate Clinical
RECRUITING
Mcallen
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
Baker Heart and Diabetes Insitute
RECRUITING
Melbourne
Canada
Aggarwal and Associates
RECRUITING
Brampton
Hamilton Medical Research Group
RECRUITING
Hamilton
Wharton Medical Clinic
RECRUITING
Hamilton
Bluewater Clinical Research Group
RECRUITING
Sarnia
Unity Healthcare Clinic
RECRUITING
Surrey
Diex Recherche Trois-Rivieres
RECRUITING
Trois-rivières
France
CHU d'Angers
RECRUITING
Angers
CHU de Bordeaux;Service d?endocrinologie, diabétologie et nutrition
RECRUITING
Pessac
CHU de Nantes - Hopital Laennec
RECRUITING
Saint-herblain
Germany
InnoDiab Forschung GmbH
RECRUITING
Essen
Medizentrum Essen Borbeck
RECRUITING
Essen
Unterfrintroper Hausarztzentrum
RECRUITING
Essen
Mesut Durmaz - Facharzt für Innere Medizin, Endokrinologie & Diabetologie
RECRUITING
Hof
Hungary
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
Japan
Kasugai Municipal Hospital
RECRUITING
Aichi
Fukuhama Chuo Clinic
RECRUITING
Fukuoka
Hasegawa Medicine Clinic
RECRUITING
Hokkaido
NTT Medical Center Sapporo
RECRUITING
Hokkaido
Higashijujo Sakai Diabetes Internal Medicine Clinic
RECRUITING
Tokyo
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
ETG Warszawa
RECRUITING
Warsaw
Spain
Hospital San Rafael A Coruna
RECRUITING
A Coruña
Hospital Vithas Sevilla
RECRUITING
Seville
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
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