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 Bimagrumab, Tirzepatide, Bimagrumab Placebo, Tirzepatide Placebo for obesity, overweight.
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 purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.
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: * Have a BMI of * ≥30 kilograms per square meter (kg/m2) or * ≥27 kg/m2 and \<30 kg/m2, with at least one of the following weight-related comorbidities: * Hypertension * Dyslipidemia * Cardiovascular disease * Obstructive sleep apnea * Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss) Exclusion Criteria: * Have a prior or planned surgical treatment for obesity * Have at least one laboratory value suggestive of diabetes during screening * Use of metformin, or any other glucose-lowering medications * Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar coma * Have poorly controlled hypertension * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes * Have ongoing or a history of bradyarrhythmias other than sinus bradycardia * Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure * Have a history of symptomatic gallbladder disease within the past 2 years * Have signs and symptoms of any liver disease * Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality * Have a history of acute or chronic pancreatitis * Have renal impairment, measured as estimated glomerular filtration rate \<30 mL/minute/1.73 m2 * Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening
Study sites by state
Alabama
- Pinnacle Research Group, LLC — Anniston
- Central Research Associates — Birmingham
California
- Diablo Clinical Research, Inc. — Walnut Creek
Florida
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville
- Altus Research — Lake Worth
- Suncoast Research Group — Miami
Hawaii
- East-West Medical Research Institute — Honolulu
Illinois
- Great Lakes Clinical Trials - Ravenswood — Chicago
Mississippi
- SKY Integrative Medical Center/SKYCRNG — Ridgeland
Pennsylvania
- Keystone Clinical Studies — Plymouth Meeting
Washington
- Eastside Research Associates — Redmond
- Rainier Clinical Research Center — Renton
View the official record on ClinicalTrials.gov →
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