Investigating weight management with Bimagrumab and Tirzepatide in adults with obesity or overweight
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight Without Type 2 Diabetes
PHASE2 · Eli Lilly and Company · NCT06643728
This study is testing whether the medications Bimagrumab and Tirzepatide, alone or together, can help adults with obesity or overweight lose weight and improve their health over about 70 weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company (industry) |
| Drugs / interventions | Bimagrumab |
| Locations | 12 sites (Anniston, Alabama and 11 other locations) |
| Trial ID | NCT06643728 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of Bimagrumab and Tirzepatide, both individually and in combination, for weight management in adults with obesity or overweight who have at least one obesity-related comorbidity but do not have Type 2 Diabetes. The trial will last approximately 70 weeks and will involve various interventions including active drugs and placebos. Participants will be monitored for changes in body weight and related health outcomes throughout the study period.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI of 27 kg/m2 or higher and at least one obesity-related comorbidity, without a diagnosis of Type 2 Diabetes.
Not a fit: Patients with a history of diabetes, poorly controlled hypertension, or recent cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new effective treatment options for weight management in adults with obesity or overweight.
How similar studies have performed: Other studies have shown promise in using similar approaches for weight management, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Anniston, Alabama and 11 other locations
- Pinnacle Research Group, LLC — Anniston, Alabama, United States (RECRUITING)
- Central Research Associates — Birmingham, Alabama, United States (RECRUITING)
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States (RECRUITING)
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States (RECRUITING)
- Altus Research — Lake Worth, Florida, United States (RECRUITING)
- Suncoast Research Group — Miami, Florida, United States (RECRUITING)
- East-West Medical Research Institute — Honolulu, Hawaii, United States (RECRUITING)
- Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States (RECRUITING)
- SKY Integrative Medical Center/SKYCRNG — Ridgeland, Mississippi, United States (RECRUITING)
- Keystone Clinical Studies — Plymouth Meeting, Pennsylvania, United States (RECRUITING)
- Eastside Research Associates — Redmond, Washington, United States (RECRUITING)
- Rainier Clinical Research Center — Renton, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
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.
Conditions: Obesity, Overweight, Muscle, Lean, Fat