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: May 12, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

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: 285
Treatment Group(s): 3
Primary Treatment: Tirzepatide
Phase: 2
Study Start date:
May 05, 2025
Estimated Completion Date:
July 23, 2027

Connect with a study center

  • Centrum Medyczne ALL-MED

    Krakow, Lesser Poland Voivodeship 30-033
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship 80-546
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk 3099434, Pomeranian Voivodeship 3337496 80-546
    Poland

    Site Not Available

  • Centrum Medyczne ALL-MED

    Krakow 3094802, 30-033
    Poland

    Site Not Available

  • Ekamed sp. z o.o.

    Lublin, 20-718
    Poland

    Site Not Available

  • Ekamed sp. z o.o.

    Lublin 765876, 20-718
    Poland

    Site Not Available

  • ETG Warszawa

    Warsaw, 02-677
    Poland

    Site Not Available

  • ETG Warszawa

    Warsaw 756135, 02-677
    Poland

    Site Not Available

  • ETG Warszawa

    Warszawa, 02-677
    Poland

    Site Not Available

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Sevilla, Barcelona 41009
    Spain

    Site Not Available

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville, Barcelona 41009
    Spain

    Site Not Available

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville 2510911, Barcelona 41009
    Spain

    Site Not Available

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta, Granada 41950
    Spain

    Site Not Available

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta 2519738, Granada 41950
    Spain

    Site Not Available

  • Hospital San Rafael A Coruna

    A Coruña, LA Coruna 15006
    Spain

    Site Not Available

  • Hospital San Rafael A Coruna

    A Coruña 3119841, LA Coruna 15006
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Fylde Coast Clinical Research at Layton Medical Centre

    Blackpool, Lancashire FY3 7EN
    United Kingdom

    Site Not Available

  • Fylde Coast Clinical Research at Layton Medical Centre

    Blackpool 2655459, Lancashire FY3 7EN
    United Kingdom

    Site Not Available

  • University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)

    Leicester, Leicestershire LE5 4PW
    United Kingdom

    Site Not Available

  • University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)

    Leicester 2644668, Leicestershire LE5 4PW
    United Kingdom

    Site Not Available

  • Accellacare Yorkshire

    Shipley, Yorkshire BD18 3SA
    United Kingdom

    Site Not Available

  • Accellacare Yorkshire

    Shipley 2637958, Yorkshire BD18 3SA
    United Kingdom

    Site Not Available

  • Accellacare Warwickshire

    Coventry, CV3 4FJ
    United Kingdom

    Site Not Available

  • Accellacare Warwickshire

    Coventry 2652221, CV3 4FJ
    United Kingdom

    Site Not Available

  • Accellacare North London

    Northwood, HA6 2RN
    United Kingdom

    Site Not Available

  • Accellacare North London

    Northwood 2641216, HA6 2RN
    United Kingdom

    Site Not Available

  • Accellacare South London

    Orpington, BR5 3QG
    United Kingdom

    Site Not Available

  • Accellacare South London

    Orpington 2640894, BR5 3QG
    United Kingdom

    Site Not Available

  • Pinnacle Research Group

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Pinnacle Research Group

    Anniston 4830198, Alabama 4829764 36207
    United States

    Site Not Available

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Site Not Available

  • Encompass Clinical Research

    Spring Valley 5398277, California 5332921 91978
    United States

    Site Not Available

  • Chase Medical Research

    Waterbury 4845193, Connecticut 4831725 06708-3346
    United States

    Site Not Available

  • K2 Medical Research-Winter Garden

    Clermont, Florida 34711
    United States

    Site Not Available

  • K2 Medical Research South Orlando, LLC

    Orlando, Florida 32806
    United States

    Site Not Available

  • K2 Medical Research-Winter Garden

    Clermont 4151352, Florida 4155751 34711
    United States

    Site Not Available

  • K2 Medical Research South Orlando, LLC

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City 4227777, Georgia 4197000 30291
    United States

    Site Not Available

  • Accellacare of Duly Health and Care

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Accellacare of Duly Health and Care

    Oak Lawn 4904365, Illinois 4896861 60453
    United States

    Site Not Available

  • Rochester Clinical Research

    Rochester, New York 14609
    United States

    Site Not Available

  • Rochester Clinical Research

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • Accellacare of Salisbury

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Rowan Diagnostic Clinic

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Accellacare of Salisbury

    Salisbury 4489985, North Carolina 4482348 28144
    United States

    Site Not Available

  • Accellacare of Piedmont Healthcare

    Statesville 4493316, North Carolina 4482348 28625
    United States

    Site Not Available

  • Accellacare of Wilmington, LLC

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Site Not Available

  • Accellacare Research of Winston Salem

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • NexGen Research

    Lima, Ohio 45801
    United States

    Site Not Available

  • NexGen Research

    Lima 5160783, Ohio 5165418 45801
    United States

    Site Not Available

  • Accellacare of Bristol/ Internal Medicine & Pediatrics

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Accellacare of Knoxville

    Knoxville, Tennessee 37912
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Accellacare of Bristol/ Internal Medicine & Pediatrics

    Bristol 4608657, Tennessee 4662168 37620
    United States

    Site Not Available

  • Accellacare of Knoxville

    Knoxville 4634946, Tennessee 4662168 37912
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas 78731
    United States

    Site Not Available

  • Juno Research, LLC

    Houston, Texas 77040
    United States

    Site Not Available

  • Consano Clinical Research

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Velocity Clinical Research (Impact Research Institute)

    Waco, Texas 76710
    United States

    Site Not Available

  • Texas Diabetes & Endocrinology, P.A.

    Austin 4671654, Texas 4736286 78731
    United States

    Site Not Available

  • Juno Research, LLC

    Houston 4699066, Texas 4736286 77040
    United States

    Site Not Available

  • Consano Clinical Research

    Shavano Park 4728147, Texas 4736286 78231
    United States

    Site Not Available

  • Velocity Clinical Research (Impact Research Institute)

    Waco 4739526, Texas 4736286 76710
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas 4771401, Virginia 6254928 20110
    United States

    Site Not Available

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