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

NCT06643728 — Phase 2, Active not recruiting, 252 participants, Eli Lilly and Company

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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

RegistryNCT06643728
StatusActive not recruiting
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment252 (Actual)
SponsorEli Lilly and Company (Industry)
ConditionsObesity, Overweight
InterventionsBimagrumab, Tirzepatide, Bimagrumab Placebo, Tirzepatide Placebo (Drug)
Datesstart 2024-10-21, primary completion 2026-01-16, completion 2027-01-01 (estimated), first posted 2024-10-16, last updated 2026-05-26
Locations12 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials for Overweight All trials of Bimagrumab All trials of Tirzepatide

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Part A: Bimagrumab Dose 2 + Tirzepatide PlaceboExperimentalDrug: Bimagrumab; Drug: Tirzepatide PlaceboParticipants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Part A: Bimagrumab Placebo + Tirzepatide Dose 1Active comparatorDrug: Tirzepatide; Drug: Bimagrumab PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide SC
Part A: Bimagrumab Placebo + Tirzepatide Dose 2Active comparatorDrug: Tirzepatide; Drug: Bimagrumab PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide SC
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1ExperimentalDrug: Bimagrumab; Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2ExperimentalDrug: Bimagrumab; Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC
Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2ExperimentalDrug: Bimagrumab; Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC
Part A: Bimagrumab Placebo + Tirzepatide PlaceboPlacebo comparatorDrug: Bimagrumab Placebo; Drug: Tirzepatide PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC
Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1ExperimentalDrug: Bimagrumab; Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC
Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1ExperimentalDrug: Bimagrumab; Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC
Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1ExperimentalDrug: Bimagrumab; Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC
Part B: Bimagrumab Dose 1 + Tirzepatide PlaceboExperimentalDrug: Bimagrumab; Drug: Tirzepatide PlaceboParticipants will receive bimagrumab SC and tirzepatide placebo SC
Part B: Bimagrumab Placebo + Tirzepatide PlaceboPlacebo comparatorDrug: Bimagrumab Placebo; Drug: Tirzepatide PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC
  • Bimagrumab (Drug), also known as LY3985863, BYM338, VER201: Administered SC
  • Tirzepatide (Drug), also known as LY3298176: Administered SC
  • Bimagrumab Placebo (Drug): Administered SC
  • Tirzepatide Placebo (Drug): Administered SC

+Outcome measures

Primary outcomes

  • Percent Change from Baseline in Body Weight [Baseline, Week 24]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (12)

FacilityCityCountryStatus
Pinnacle Research Group, LLCAnniston, AlabamaUnited States
Central Research AssociatesBirmingham, AlabamaUnited States
Diablo Clinical Research, Inc.Walnut Creek, CaliforniaUnited States
Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonville, FloridaUnited States
Altus ResearchLake Worth, FloridaUnited States
Suncoast Research GroupMiami, FloridaUnited States
East-West Medical Research InstituteHonolulu, HawaiiUnited States
Great Lakes Clinical Trials - RavenswoodChicago, IllinoisUnited States
SKY Integrative Medical Center/SKYCRNGRidgeland, MississippiUnited States
Keystone Clinical StudiesPlymouth Meeting, PennsylvaniaUnited States
Eastside Research AssociatesRedmond, WashingtonUnited States
Rainier Clinical Research CenterRenton, WashingtonUnited States

+Investigators

  • 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