A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight
- Conditions
- ObesityOverweight
- Interventions
- Registration Number
- NCT06643728
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
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Have a BMI of
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≥30 kilograms per square meter (kg/m2) or
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≥27 kg/m2 and <30 kg/m2, with at least one of the following weight-related comorbidities:
- Hypertension
- Dyslipidemia
- Cardiovascular disease
- Obstructive sleep apnea
-
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Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)
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Have a prior or planned surgical treatment for obesity
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Have at least one laboratory value suggestive of diabetes during screening
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Use of metformin, or any other glucose-lowering medications
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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
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Have poorly controlled hypertension
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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
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Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
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Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
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Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
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Have a history of symptomatic gallbladder disease within the past 2 years
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Have signs and symptoms of any liver disease
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Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality
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Have a history of acute or chronic pancreatitis
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Have renal impairment, measured as estimated glomerular filtration rate <30 mL/minute/1.73 m2
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Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Bimagrumab Dose 2 + Tirzepatide Placebo Bimagrumab Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC Part A: Bimagrumab Dose 2 + Tirzepatide Placebo Tirzepatide Placebo Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC Part A: Bimagrumab Placebo + Tirzepatide Dose 1 Tirzepatide Participants will receive bimagrumab placebo SC and tirzepatide SC Part A: Bimagrumab Placebo + Tirzepatide Dose 1 Bimagrumab Placebo Participants will receive bimagrumab placebo SC and tirzepatide SC Part A: Bimagrumab Placebo + Tirzepatide Dose 2 Tirzepatide Participants will receive bimagrumab placebo SC and tirzepatide SC Part A: Bimagrumab Placebo + Tirzepatide Dose 2 Bimagrumab Placebo Participants will receive bimagrumab placebo SC and tirzepatide SC Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Part A: Bimagrumab Placebo + Tirzepatide Placebo Bimagrumab Placebo Participants will receive bimagrumab placebo SC and tirzepatide placebo SC Part A: Bimagrumab Placebo + Tirzepatide Placebo Tirzepatide Placebo Participants will receive bimagrumab placebo SC and tirzepatide placebo SC Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Part B: Bimagrumab Dose 1 + Tirzepatide Placebo Bimagrumab Participants will receive bimagrumab SC and tirzepatide placebo SC Part B: Bimagrumab Dose 1 + Tirzepatide Placebo Tirzepatide Placebo Participants will receive bimagrumab SC and tirzepatide placebo SC Part B: Bimagrumab Placebo + Tirzepatide Placebo Bimagrumab Placebo Participants will receive bimagrumab placebo SC and tirzepatide placebo SC Part B: Bimagrumab Placebo + Tirzepatide Placebo Tirzepatide Placebo Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 24
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA) Baseline, Week 24, Week 48 Change from Baseline in Body Weight Baseline, Week 24, Week 48 Percentage of Participants Achieving ≥5% Body Weight Reduction Baseline, Week 24, Week 48 Percentage of Participants Achieving ≥10% Body Weight Reduction Baseline, Week 24, Week 48 Percentage of Participants Achieving ≥15% Body Weight Reduction Baseline, Week 24, Week 48 Change from Baseline in Waist Circumference Baseline, Week 24, Week 48 Change from Baseline in Body Mass Index (BMI) Baseline, Week 24, Week 48 Change from Baseline in Waist-to-Height Ratio (WHtR) Baseline, Week 24, Week 48 Percent Change from Baseline in Visceral Adipose Tissue (VAT) Baseline, Week 24, Week 48 Percent Change from Baseline in Total Body Lean Mass by DXA Baseline, Week 24, Week 48
Trial Locations
- Locations (12)
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Great Lakes Clinical Trials - Ravenswood
🇺🇸Chicago, Illinois, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Keystone Clinical Studies
🇺🇸Plymouth Meeting, Pennsylvania, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Central Research Associates
🇺🇸Birmingham, Alabama, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States