A Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Assess Efficacy, Safety, and Tolerability of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-related comorbidities are not required for inclusion)
• BMI ≥ 27.0 kg/m² and \< 30.0 kg/m² with at least one weight-related comorbidity such as: hypertension, dyslipidemia, obstructive sleep apnea and any cardiovascular disease
• History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight
• Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11 pounds \[lbs\]) within 3 months prior to screening
Locations
United States
Alabama
Pinnacle Research Group
RECRUITING
Anniston
California
Encompass Clinical Research
RECRUITING
Spring Valley
Connecticut
Chase Medical Research
WITHDRAWN
Waterbury
Florida
K2 Medical Research South Orlando, LLC
RECRUITING
Orlando
Georgia
Rophe Adult and Pediatric Medicine/SKYCRNG
RECRUITING
Union City
Illinois
Accellacare of Duly Health and Care
RECRUITING
Oak Lawn
North Carolina
Accellacare of Salisbury
RECRUITING
Salisbury
Accellacare of Piedmont Healthcare
RECRUITING
Statesville
Accellacare of Wilmington, LLC
RECRUITING
Wilmington
Accellacare Research of Winston Salem
RECRUITING
Winston-salem
New York
Rochester Clinical Research
RECRUITING
Rochester
Ohio
NexGen Research
RECRUITING
Lima
Tennessee
Accellacare of Bristol/ Internal Medicine & Pediatrics
RECRUITING
Bristol
Accellacare of Knoxville
RECRUITING
Knoxville
Clinical Research Associates
RECRUITING
Nashville
Texas
Texas Diabetes & Endocrinology, P.A.
RECRUITING
Austin
Juno Research, LLC
RECRUITING
Houston
Consano Clinical Research
RECRUITING
Shavano Park
Velocity Clinical Research (Impact Research Institute)
RECRUITING
Waco
Virginia
Manassas Clinical Research Center
RECRUITING
Manassas
Other Locations
Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
RECRUITING
Gdansk
Centrum Medyczne ALL-MED
RECRUITING
Krakow
Ekamed sp. z o.o.
RECRUITING
Lublin
ETG Warszawa
RECRUITING
Warsaw
Spain
Hospital San Rafael A Coruna
RECRUITING
A Coruña
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Vithas Nisa Sevilla
RECRUITING
Castilleja De La Cuesta
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Universidad de Sevilla - Hospital Universitario Virgen Macarena
RECRUITING
Seville
United Kingdom
Fylde Coast Clinical Research at Layton Medical Centre
RECRUITING
Blackpool
Accellacare Warwickshire
RECRUITING
Coventry
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
RECRUITING
Leicester
Accellacare North London
RECRUITING
Northwood
Accellacare South London
RECRUITING
Orpington
Accellacare Yorkshire
RECRUITING
Shipley
Contact Information
Primary
Reference Study ID Number: BC45538 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Time Frame
Start Date:2025-05-05
Estimated Completion Date:2027-09-20
Participants
Target number of participants:234
Treatments
Active_comparator: Placebo + Tirzepatide
Participants will receive RO7204239 matching placebo via subcutaneous (SC) injection every 4 weeks (Q4W) for the core treatment period of 48 weeks and the treatment extension period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, every week (QW) during the core treatment period of 48 weeks.
Experimental: RO7204239 low dose + Tirzepatide
Participants will receive RO7204239, low dose, SC, Q4W for the core treatment period of 48 weeks. During the treatment extension period participants will receive placebo for the period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks.
Experimental: RO7204239 medium dose + Tirzepatide
Participants will receive RO7204239, medium dose, SC, Q4W for the core treatment period of 48 weeks. During the treatment extension period participants will receive placebo for the period of 24 weeks. Participants will also receive tirzepatide, as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks.
Experimental: RO7204239 high dose + Tirzepatide
Participants will receive RO7204239, high dose, SC, Q4W along with tirzepatide, given as a background therapy, up-titrated according to the approved tirzepatide prescribing information, SC, QW during the core treatment period of 48 weeks. During the treatment extension period participants will be randomized to receive RO7204239 or matching placebo, SC, Q4W for 24 weeks.