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ACTIVE NOT RECRUITING
NCT06965413
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

RO7204239

RO7204239 or matching placebo will be administered as per the schedule specified in the arms.

DRUG

RO7204239 Matching Placebo

RO7204239 matching placebo will be administered as per the schedule specified in the arm.

DRUG

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