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Clinical Trials in the UK / NCT06965413
Active, not recruiting Phase 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

NCT06965413 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2025-05-05
Last updated
2026-09-09

Condition(s) studied

ObesityOverweightOverweight With One Weight Related Comorbidity

Investigational drug(s) / intervention(s)

RO7204239RO7204239 Matching PlaceboTirzepatide

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.

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 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 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)

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
Pinnacle Research Group Anniston Alabama
Encompass Clinical Research Spring Valley California
K2 Medical Research-Winter Garden Clermont Florida
Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia
Accellacare of Duly Health and Care Oak Lawn Illinois
Rochester Clinical Research Rochester New York
Accellacare of Salisbury Salisbury North Carolina
Accellacare of Piedmont Healthcare Statesville North Carolina
Accellacare of Wilmington, LLC Wilmington North Carolina
Accellacare Research of Winston Salem Winston-Salem North Carolina
NexGen Research Lima Ohio
Accellacare of Bristol/ Internal Medicine & Pediatrics Bristol Tennessee
Accellacare of Knoxville Knoxville Tennessee
Clinical Research Associates Nashville Tennessee
Texas Diabetes & Endocrinology, P.A. Austin Texas
Juno Research, LLC Houston Texas
Consano Clinical Research Shavano Park Texas
Velocity Clinical Research (Impact Research Institute) Waco Texas
Manassas Clinical Research Center Manassas Virginia
Centrum Medyczne ALL-MED Krakow Lesser Poland Voivodeship
Penta Hospials Badania Kliniczne Gdansk Gdansk Pomeranian Voivodeship
Ekamed sp. z o.o. Lublin Poland
ETG Warszawa Warsaw Poland
Universidad de Sevilla - Hospital Universitario Virgen Macarena Seville Barcelona
Instituto De Investigacion Marques De Valdecilla (IDIVAL) Santander Cantabria
Hospital Vithas Nisa Sevilla Castilleja de la Cuesta Granada
Hospital San Rafael A Coruna A Coruña LA Coruna
Hospital Universitario Vall d'Hebron Barcelona Spain
Hospital Universitario Virgen de la Victoria Málaga Spain
Fylde Coast Clinical Research at Layton Medical Centre Blackpool Lancashire
University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH) Leicester Leicestershire
Accellacare Yorkshire Shipley Yorkshire
Accellacare Warwickshire Coventry United Kingdom
Accellacare North London Northwood United Kingdom
Accellacare South London Orpington United Kingdom

On this site

📄 Mounjaro (tirzepatide) drug profile →

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06965413 on ClinicalTrials.gov ↗ ← All trials in the UK