Investigating weight management with Bimagrumab and Tirzepatide in adults with obesity or overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.