Clinical trial

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

Active, not recruiting · Phase 2 · 4 countries · Registry ID NCT06965413

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight, Overweight With One Weight Related Comorbidity

Full registry criteria

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)

Treatments and study arms

RO7204239

Drug

RO7204239 or matching placebo will be administered as per the schedule specified in the arms.

RO7204239 Matching Placebo

Drug

RO7204239 matching placebo will be administered as per the schedule specified in the arm.

Tirzepatide

Drug

Tirzepatide will be administered as per the schedule specified in the arms.

Primary outcomes

Percent Change From Baseline in Body WeightBaseline, Week 48

Study locations

35 locations were listed when this page was built. The first 40 are shown.

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