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
NCT ID: NCT06965413
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
285 participants
INTERVENTIONAL
2025-05-05
2027-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
RO7204239
RO7204239 or matching placebo will be administered as per the schedule specified in the arms.
Tirzepatide
Tirzepatide will be administered as per the schedule specified in the arms.
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.
RO7204239
RO7204239 or matching placebo will be administered as per the schedule specified in the arms.
Tirzepatide
Tirzepatide will be administered as per the schedule specified in the arms.
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.
RO7204239
RO7204239 or matching placebo will be administered as per the schedule specified in the arms.
Tirzepatide
Tirzepatide will be administered as per the schedule specified in the arms.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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 months prior to screening
* Have a known clinically significant gastric emptying abnormality
* Have any of the following cardiovascular conditions within 6 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF)
* Have evidence of significant active, uncontrolled cardiovascular, autoimmune, endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, a neurological or psychiatric condition, or a history of any neuromuscular disorder or autoimmune/inflammatory disorders that may cause muscle wasting or medical condition capable of constituting a risk when taking the study medication or interfering with the interpretation of data, as judged by the investigator at screening
* Have evidence of a significant, uncontrolled endocrine abnormality
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy
* Have evidence of a significant, active autoimmune abnormality
* Have anemia
* Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Encompass Clinical Research
Spring Valley, California, United States
K2 Medical Research South Orlando, LLC
Orlando, 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
Countries
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Other Identifiers
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2024-519561-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
BC45538
Identifier Type: -
Identifier Source: org_study_id