Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06643728

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research Group, LLC, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimagrumab

Drug

Administered SC

Other names: LY3985863, BYM338, VER201

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Bimagrumab Placebo

Drug

Administered SC

Tirzepatide Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 24

Secondary outcomes

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

    Time frame: Baseline, Week 24, Week 48

  2. Change from Baseline in Body Weight

    Time frame: Baseline, Week 24, Week 48

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

    Time frame: Baseline, Week 24, Week 48

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

    Time frame: Baseline, Week 24, Week 48

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

    Time frame: Baseline, Week 24, Week 48

  6. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 24, Week 48

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

    Time frame: Baseline, Week 24, Week 48

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

    Time frame: Baseline, Week 24, Week 48

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

    Time frame: Baseline, Week 24, Week 48

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

    Time frame: Baseline, Week 24, Week 48

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 16, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.