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NCT06965413Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
285 (actual)
First submitted
2 May 2025
Start date
5 May 2025
Primary completion date
3 Sept 2026
Lead sponsor
Hoffmann-La Roche
Diseases
Obesity
NCT number
NCT06965413
EU CT number
2024-519561-22-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 285
  • From 5 May 2025 to the primary completion date, 3 Sept 2026
  • 40 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior history or diagnosis of DM
  • Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema
  • 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 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)

Other illness

  • Have obesity induced by other endocrinologic disorders
  • 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 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 signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease

Other

  • Participation in unbalanced/extreme diets
  • Have a known clinically significant gastric emptying abnormality
  • Have evidence of a significant, uncontrolled endocrine abnormality
  • Have anemia
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Medico Quirurgico San Rafael S.A.
Coordinator of this site? Confirm its status
A CorunaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainActive, not recruiting
Area Sanitaria De Ferrol
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FerrolSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Fylde Coast Clinical Research at Layton Medical Centre
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BlackpoolUnited KingdomUnknown status
Accellacare Warwickshire
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CoventryUnited KingdomUnknown status
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)
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LeicesterUnited KingdomUnknown status
Accellacare North London
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NorthwoodUnited KingdomUnknown status
Accellacare South London
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OrpingtonUnited KingdomUnknown status
Accellacare Yorkshire
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ShipleyUnited KingdomUnknown status
Centrum Medyczne All-Med Badania Kliniczne
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CracowPolandActive, not recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandActive, not recruiting
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandActive, not recruiting
EKAMED sp. z o.o.
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LublinPolandActive, not recruiting
Etg Warszawa Sp. z o.o.
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WarsawPolandActive, not recruiting
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
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WroclawPolandActive, not recruiting
Pinnacle Research Group
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AnnistonUnited StatesUnknown status
Texas Diabetes & Endocrinology, P.A.
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AustinUnited StatesUnknown status
Accellacare of Bristol/ Internal Medicine & Pediatrics
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BristolUnited StatesUnknown status
K2 Medical Research WINTER GARDEN
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ClermontUnited StatesUnknown status
Juno Research, LLC
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HoustonUnited StatesUnknown status
Accellacare of Knoxville
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KnoxvilleUnited StatesUnknown status
NexGen Research
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LimaUnited StatesUnknown status
Manassas Clinical Research Center
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ManassasUnited StatesUnknown status
Clinical Research Associates
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NashvilleUnited StatesUnknown status
Accellacare of Duly Health and Care
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Oak LawnUnited StatesUnknown status
Rochester Clinical Research
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RochesterUnited StatesUnknown status
Accellacare of Salisbury
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SalisburyUnited StatesUnknown status
Consano Clinical Research
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Shavano ParkUnited StatesUnknown status
Encompass Clinical Research
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Spring ValleyUnited StatesUnknown status
Accellacare of Piedmont HealthCare
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StatesvilleUnited StatesUnknown status
Rophe Adult and Pediatric Medicine/SKYCRNG
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Union CityUnited StatesUnknown status
Velocity Clinical Research (Impact Research Institute)
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WacoUnited StatesUnknown status
Accellacare of Wilmington, LLC
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WilmingtonUnited StatesUnknown status
Accellacare Research of Winston Salem
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.