A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight

Launched by ELI LILLY AND COMPANY · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness and safety of two medications, Bimagrumab and Tirzepatide, for helping adults with obesity or who are overweight manage their weight. The study is specifically looking at individuals who have a body mass index (BMI) of 27 or higher and at least one health issue related to weight, such as high blood pressure or sleep apnea, but do not have Type 2 diabetes. The trial will last about 54 weeks and is currently seeking participants.

To be eligible for this study, participants should be between the ages of 18 and 75, have been stable in their weight for the last three months (meaning they haven’t lost or gained more than 5% of their body weight), and meet certain health criteria. However, individuals who have undergone weight-loss surgery, have diabetes, or have certain heart or kidney conditions cannot participate. Those who join the trial can expect regular visits for assessments and monitoring throughout the study period, which will help researchers understand how well these medications work for weight management.

Gender

ALL

Eligibility 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