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

Last updated: July 25, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Prevention

Hypertriglyceridemia

Obesity

Treatment

Tirzepatide

RO7204239

RO7204239 Matching Placebo

Clinical Study ID

NCT06965413
BC45538
2024-519561-22-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-relatedcomorbidities are not required for inclusion)

  • BMI ≥ 27.0 kg/m² and < 30.0 kg/m² with at least one weight-related comorbidity suchas: hypertension, dyslipidemia, obstructive sleep apnea and any cardiovasculardisease

  • History of at least one self-reported unsuccessful dietary or exercise effort tolose body weight

  • Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11pounds [lbs]) within 3 months prior to screening

Exclusion

Exclusion Criteria:

  • Prior history or diagnosis of DM

  • Presence of non-proliferative diabetic retinopathy requiring acute therapy,proliferative diabetic retinopathy or diabetic macular edema

  • Have obesity induced by other endocrinologic disorders

  • Participation in unbalanced/extreme diets

  • Prior or planned surgical treatment for obesity

  • Endoscopic and/or device-based therapy for obesity or device removal within 6 monthsprior to screening

  • Have a known clinically significant gastric emptying abnormality

  • Have any of the following cardiovascular conditions within 6 months prior toscreening: acute myocardial infarction, cerebrovascular accident (stroke), unstableangina, or hospitalization due to congestive heart failure (CHF)

  • Have evidence of significant active, uncontrolled cardiovascular, autoimmune,endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinaldisease, a neurological or psychiatric condition, or a history of any neuromusculardisorder or autoimmune/inflammatory disorders that may cause muscle wasting ormedical condition capable of constituting a risk when taking the study medication orinterfering with the interpretation of data, as judged by the investigator atscreening

  • Have evidence of a significant, uncontrolled endocrine abnormality

  • Have a history of an active or untreated malignancy or are in remission from aclinically significant malignancy

  • Have evidence of a significant, active autoimmune abnormality

  • Have anemia

  • Have signs and symptoms of any other liver disease other than nonalcoholic fattyliver disease

  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14units per week (females)

Study Design

Total Participants: 234
Treatment Group(s): 3
Primary Treatment: Tirzepatide
Phase: 2
Study Start date:
May 05, 2025
Estimated Completion Date:
September 20, 2027

Connect with a study center

  • ETG Warszawa

    Warszawa, 02-677
    Poland

    Active - Recruiting

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Sevilla, Barcelona 41009
    Spain

    Active - Recruiting

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta, Granada 41950
    Spain

    Active - Recruiting

  • Accellacare Yorkshire

    Shipley, Yorkshire BD18 3SA
    United Kingdom

    Active - Recruiting

  • Pinnacle Research Group

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Active - Recruiting

  • K2 Medical Research South Orlando, LLC

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Active - Recruiting

  • Accellacare of Duly Health and Care

    Oak Lawn, Illinois 60453
    United States

    Active - Recruiting

  • Rochester Clinical Research

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Accellacare of Salisbury

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Rowan Diagnostic Clinic

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Active - Recruiting

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • NexGen Research

    Lima, Ohio 45801
    United States

    Active - Recruiting

  • Accellacare of Bristol/ Internal Medicine & Pediatrics

    Bristol, Tennessee 37620
    United States

    Active - Recruiting

  • Accellacare of Knoxville

    Knoxville, Tennessee 37912
    United States

    Active - Recruiting

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Juno Research, LLC

    Houston, Texas 77040
    United States

    Active - Recruiting

  • Consano Clinical Research

    Shavano Park, Texas 78231
    United States

    Active - Recruiting

  • Velocity Clinical Research (Impact Research Institute)

    Waco, Texas 76710
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.