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A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity
Sponsor: Hoffmann-La Roche
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
285
Start Date
2025-05-05
Completion Date
2027-07-23
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
RO7204239
RO7204239 or matching placebo will be administered as per the schedule specified in the arms.
RO7204239 Matching Placebo
RO7204239 matching placebo will be administered as per the schedule specified in the arm.
Tirzepatide
Tirzepatide will be administered as per the schedule specified in the arms.
Locations (35)
Pinnacle Research Group
Anniston, Alabama, United States
Encompass Clinical Research
Spring Valley, California, United States
K2 Medical Research-Winter Garden
Clermont, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Accellacare of Duly Health and Care
Oak Lawn, Illinois, United States
Rochester Clinical Research
Rochester, New York, United States
Accellacare of Salisbury
Salisbury, North Carolina, United States
Accellacare of Piedmont Healthcare
Statesville, North Carolina, United States
Accellacare of Wilmington, LLC
Wilmington, North Carolina, United States
Accellacare Research of Winston Salem
Winston-Salem, North Carolina, United States
NexGen Research
Lima, Ohio, United States
Accellacare of Bristol/ Internal Medicine & Pediatrics
Bristol, Tennessee, United States
Accellacare of Knoxville
Knoxville, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
Velocity Clinical Research (Impact Research Institute)
Waco, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne ALL-MED
Krakow, Poland
Ekamed sp. z o.o.
Lublin, Poland
ETG Warszawa
Warsaw, Poland
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, Granada, Spain
Hospital San Rafael A Coruna
A Coruña, LA Coruna, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool, Lancashire, United Kingdom
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
Leicester, Leicestershire, United Kingdom
Accellacare Yorkshire
Shipley, Yorkshire, United Kingdom
Accellacare Warwickshire
Coventry, United Kingdom
Accellacare North London
Northwood, United Kingdom
Accellacare South London
Orpington, United Kingdom