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HomeTrials › NCT06965413

Obesity & weight · Phase 2 · Active, not recruiting

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 · Sponsor: Hoffmann-La Roche

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying RO7204239, RO7204239 Matching Placebo, Tirzepatide for obesity, overweight, overweight with one weight related comorbidity.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeRO7204239, RO7204239 Matching Placebo, Tirzepatide
Study length~16 months overall
Planned participants285
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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)

Study sites by state

Alabama

  • Pinnacle Research Group — Anniston

California

  • Encompass Clinical Research — Spring Valley

Florida

  • K2 Medical Research-Winter Garden — Clermont

Georgia

  • Rophe Adult and Pediatric Medicine/SKYCRNG — Union City

Illinois

  • Accellacare of Duly Health and Care — Oak Lawn

New York

  • Rochester Clinical Research — Rochester

North Carolina

  • Accellacare of Salisbury — Salisbury
  • Accellacare of Piedmont Healthcare — Statesville
  • Accellacare of Wilmington, LLC — Wilmington
  • Accellacare Research of Winston Salem — Winston-Salem

Ohio

  • NexGen Research — Lima

Tennessee

  • Accellacare of Bristol/ Internal Medicine & Pediatrics — Bristol
  • Accellacare of Knoxville — Knoxville
  • Clinical Research Associates — Nashville

Texas

  • Texas Diabetes & Endocrinology, P.A. — Austin
  • Juno Research, LLC — Houston
  • Consano Clinical Research — Shavano Park
  • Velocity Clinical Research (Impact Research Institute) — Waco

Virginia

  • Manassas Clinical Research Center — Manassas

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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