Assessing a new treatment for obesity with a combination of medications
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
This study is testing a new combination of medications to see if it can help adults with obesity or overweight lose weight more effectively than a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 11 sites (Anniston, Alabama and 10 other locations) |
| Trial ID | NCT06965413 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7204239 when used alongside tirzepatide in adults with obesity or overweight who have at least one weight-related comorbidity. Participants will undergo a 4-week screening, followed by a 48-week treatment period where they will receive tirzepatide and be randomized into different treatment arms. After this, there will be a 24-week treatment extension and a 24-week post-treatment follow-up to assess long-term effects. The study aims to determine the impact of the combination therapy on weight loss compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates include adults with a BMI of 27 or higher who have at least one weight-related comorbidity but do not have diabetes.
Not a fit: Patients with a prior diagnosis of diabetes or those whose obesity is caused by other endocrinologic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly aid in weight loss for individuals struggling with obesity and related health issues.
How similar studies have performed: Other studies have shown promising results with similar combination therapies for obesity, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Anniston, Alabama and 10 other locations
- Pinnacle Research Group — Anniston, Alabama, United States (Recruiting)
- Encompass Clinical Research — Spring Valley, California, United States (Recruiting)
- K2 Medical Research South Orlando, LLC — Orlando, Florida, United States (Recruiting)
- Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States (Recruiting)
- Accellacare of Piedmont Healthcare — Statesville, North Carolina, United States (Recruiting)
- Accellacare of Wilmington, LLC — Wilmington, North Carolina, United States (Recruiting)
- Accellacare Research of Winston Salem — Winston-Salem, North Carolina, United States (Recruiting)
- Accellacare of Bristol/ Internal Medicine & Pediatrics — Bristol, Tennessee, United States (Recruiting)
- Accellacare of Knoxville — Knoxville, Tennessee, United States (Recruiting)
- Juno Research, LLC — Houston, Texas, United States (Recruiting)
- Consano Clinical Research — Shavano Park, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: BC45538 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S.)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.