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Active, not recruitingNCT06643728Updated May 26, 2026

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

A Phase 2 interventional study of Bimagrumab and Tirzepatide in Obesity and Overweight, sponsored by Eli Lilly and Company. Active, not recruiting at 12 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight

Keywords

  • Muscle
  • Lean
  • Fat
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 252 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
252 participants (actual)

Study arms

  • Experimental
    Part A: Bimagrumab Dose 2 + Tirzepatide Placebo

    Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC

    Drug: Bimagrumab · Drug: Tirzepatide Placebo

  • Active comparator
    Part A: Bimagrumab Placebo + Tirzepatide Dose 1

    Participants will receive bimagrumab placebo SC and tirzepatide SC

    Drug: Tirzepatide · Drug: Bimagrumab Placebo

  • Active comparator
    Part A: Bimagrumab Placebo + Tirzepatide Dose 2

    Participants will receive bimagrumab placebo SC and tirzepatide SC

    Drug: Tirzepatide · Drug: Bimagrumab Placebo

  • Experimental
    Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1

    Participants will receive bimagrumab SC and tirzepatide SC

    Drug: Bimagrumab · Drug: Tirzepatide

  • Experimental
    Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2

    Participants will receive bimagrumab SC and tirzepatide SC

    Drug: Bimagrumab · Drug: Tirzepatide

  • Experimental
    Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2

    Participants will receive bimagrumab SC and tirzepatide SC

    Drug: Bimagrumab · Drug: Tirzepatide

  • Placebo comparator
    Part A: Bimagrumab Placebo + Tirzepatide Placebo

    Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

    Drug: Bimagrumab Placebo · Drug: Tirzepatide Placebo

  • Experimental
    Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1

    Participants will receive bimagrumab SC and tirzepatide SC

    Drug: Bimagrumab · Drug: Tirzepatide

  • Experimental
    Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1

    Participants will receive bimagrumab SC and tirzepatide SC

    Drug: Bimagrumab · Drug: Tirzepatide

  • Experimental
    Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1

    Participants will receive bimagrumab SC and tirzepatide SC

    Drug: Bimagrumab · Drug: Tirzepatide

  • Experimental
    Part B: Bimagrumab Dose 1 + Tirzepatide Placebo

    Participants will receive bimagrumab SC and tirzepatide placebo SC

    Drug: Bimagrumab · Drug: Tirzepatide Placebo

  • Placebo comparator
    Part B: Bimagrumab Placebo + Tirzepatide Placebo

    Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

    Drug: Bimagrumab Placebo · Drug: Tirzepatide Placebo

Interventions

  • DrugBimagrumab

    Administered SC

    Also known as: LY3985863, BYM338, VER201

  • DrugTirzepatide

    Administered SC

    Also known as: LY3298176

  • DrugBimagrumab Placebo

    Administered SC

  • DrugTirzepatide Placebo

    Administered SC

06

What researchers measure

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

07

Study locations

12 sites
  • Pinnacle Research Group, LLC
    Anniston, Alabama 36207, United States
  • Central Research Associates
    Birmingham, Alabama 35205, United States
  • Diablo Clinical Research, Inc.
    Walnut Creek, California 94598, United States
  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    Jacksonville, Florida 32256, United States
  • Altus Research
    Lake Worth, Florida 33461, United States
  • Suncoast Research Group
    Miami, Florida 33135, United States
  • East-West Medical Research Institute
    Honolulu, Hawaii 96814, United States
  • Great Lakes Clinical Trials - Ravenswood
    Chicago, Illinois 60640, United States
  • SKY Integrative Medical Center/SKYCRNG
    Ridgeland, Mississippi 39157, United States
  • Keystone Clinical Studies
    Plymouth Meeting, Pennsylvania 19462, United States
  • Eastside Research Associates
    Redmond, Washington 98052, United States
  • Rainier Clinical Research Center
    Renton, Washington 98057, United States
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06643728
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 16, 2024
Start date
Oct 21, 2024
Primary completion
Jan 16, 2026
Completion
Jan 2027 (estimated)
Last update
May 26, 2026

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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