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

Phase
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Eli Lilly and Company
Start date
Number of sites

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

Control arm
Registry reports results
Listing at source
Recruitment status
Active, not recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Eli Lilly and Company
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

  1. Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 24

  1. Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)

    Timeframe: Baseline, Week 24, Week 48

  2. Change from Baseline in Body Weight

    Timeframe: Baseline, Week 24, Week 48

  3. Percentage of Participants Achieving ≥5% Body Weight Reduction

    Timeframe: Baseline, Week 24, Week 48

  4. Percentage of Participants Achieving ≥10% Body Weight Reduction

    Timeframe: Baseline, Week 24, Week 48

  5. Percentage of Participants Achieving ≥15% Body Weight Reduction

    Timeframe: Baseline, Week 24, Week 48

  6. Change from Baseline in Waist Circumference

    Timeframe: Baseline, Week 24, Week 48

  7. Change from Baseline in Body Mass Index (BMI)

    Timeframe: Baseline, Week 24, Week 48

  8. Change from Baseline in Waist-to-Height Ratio (WHtR)

    Timeframe: Baseline, Week 24, Week 48

  9. Percent Change from Baseline in Visceral Adipose Tissue (VAT)

    Timeframe: Baseline, Week 24, Week 48

  10. Percent Change from Baseline in Total Body Lean Mass by DXA

    Timeframe: Baseline, Week 24, Week 48

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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)

  • 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

Sources for eligibility

  • Pinnacle Research Group, LLCAnniston, United States
  • Central Research AssociatesBirmingham, United States
  • Diablo Clinical Research, Inc.Walnut Creek, United States
  • Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonville, United States
  • Altus ResearchLake Worth, United States
  • Suncoast Research GroupMiami, United States
  • East-West Medical Research InstituteHonolulu, United States
  • Great Lakes Clinical Trials - RavenswoodChicago, United States
  • SKY Integrative Medical Center/SKYCRNGRidgeland, United States
  • Keystone Clinical StudiesPlymouth Meeting, United States
  • Eastside Research AssociatesRedmond, United States
  • Rainier Clinical Research CenterRenton, United States
Sources for sites

Other registry identifiers

  • J4Z-MC-GIDF
Sources for references

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (4)