A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes

Phase 2

Withdrawn

• Conditions: Obesity; Overweight
• Interventions: Drug: Bimagrumab; Drug: Tirzepatide; Drug: Tirzepatide Placebo; Drug: Bimagrumab Placebo

• Registration Number: NCT06901349
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-28
• Study Start: 2025-05-23
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-10
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Have type 2 diabetes
• Have a BMI of ≥27 kilograms per square meter (kg/m2)
• 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 type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar state or 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 a history of New York Heart Association (NYHA) Functional Classification III or IV 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 renal impairment

• 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

• 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
Bimagrumab Dose 1 + Tirzepatide Placebo	Bimagrumab	Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Bimagrumab Dose 1 + Tirzepatide Placebo	Tirzepatide Placebo	Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Bimagrumab Dose 2 + Tirzepatide Placebo	Bimagrumab	Participants will receive bimagrumab SC and tirzepatide placebo SC
Bimagrumab Dose 2 + Tirzepatide Placebo	Tirzepatide Placebo	Participants will receive bimagrumab SC and tirzepatide placebo SC
Tirzepatide Dose 1 + Bimagrumab Placebo	Tirzepatide	Participants will receive tirzepatide SC and bimagrumab placebo SC
Tirzepatide Dose 1 + Bimagrumab Placebo	Bimagrumab Placebo	Participants will receive tirzepatide SC and bimagrumab placebo SC
Tirzepatide Dose 2 + Bimagrumab Placebo	Tirzepatide	Participants will receive tirzepatide SC and bimagrumab placebo SC
Tirzepatide Dose 2 + Bimagrumab Placebo	Bimagrumab Placebo	Participants will receive tirzepatide SC and bimagrumab placebo SC
Bimagrumab Dose 2 + Tirzepatide Dose 1	Bimagrumab	Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 2 + Tirzepatide Dose 1	Tirzepatide	Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 1 + Tirzepatide Dose 1	Bimagrumab	Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 1 + Tirzepatide Dose 1	Tirzepatide	Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 2 + Tirzepatide Dose 2	Bimagrumab	Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 2 + Tirzepatide Dose 2	Tirzepatide	Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 1 + Tirzepatide Dose 2	Bimagrumab	Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 1 + Tirzepatide Dose 2	Tirzepatide	Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Placebo + Tirzepatide Placebo	Bimagrumab Placebo	Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
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 36

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving ≥10% Body Weight Reduction	Baseline, Week 36
Percentage of Participants Achieving ≥15% Body Weight Reduction	Baseline, Week 36
Change from Baseline in Waist Circumference	Baseline, Week 36
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 36
Change from Baseline in Waist-to-Height Ratio (WHtR)	Baseline, Week 36
Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI)	Baseline, Week 36
Change from Baseline in Liver Fat by MRI	Baseline, Week 36
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)	Baseline, Week 36
Percent Change from Baseline in Total Cholesterol	Baseline, Week 36
Percent Change from Baseline in Triglycerides (TG)	Baseline, Week 36
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 36
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab	Predose through Week 52
Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)	Baseline, Week 36
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 36
Percentage of Participants Achieving ≥5% Body Weight Reduction	Baseline, Week 36

Trial Locations

Locations (94)

Yuma Clinical Trials; 🇺🇸 Yuma, Arizona, United States

Orange County Research Center; 🇺🇸 Lake Forest, California, United States

Healthy Brain Clinic; 🇺🇸 Long Beach, California, United States

Valley Clinical Trials, Inc.; 🇺🇸 Northridge, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare; 🇺🇸 Jacksonville, Florida, United States

Global Health Research Center, Inc.; 🇺🇸 Miami Lakes, Florida, United States

L&C Professional Medical Research Institute; 🇺🇸 Miami, Florida, United States

Charter Research - Winter Park; 🇺🇸 Orlando, Florida, United States

Charter Research - Lady Lake; 🇺🇸 The Villages, Florida, United States

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