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Active, not recruiting Phase 2

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

NCT06643728 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2024-10-21
Last updated
2026-05-26

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

Bimagrumab →Tirzepatide →Bimagrumab PlaceboTirzepatide Placebo

Bimagrumab: Administered SC

Tirzepatide: Administered SC

Bimagrumab Placebo: Administered SC

Tirzepatide Placebo: Administered SC

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
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: * 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

Primary outcome measure(s)

  • Percent Change from Baseline in Body Weight — Baseline, Week 24

Trial sites (12)

FacilityCityRegionStatus
Pinnacle Research Group, LLC Anniston Alabama
Central Research Associates Birmingham Alabama
Diablo Clinical Research, Inc. Walnut Creek California
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare Jacksonville Florida
Altus Research Lake Worth Florida
Suncoast Research Group Miami Florida
East-West Medical Research Institute Honolulu Hawaii
Great Lakes Clinical Trials - Ravenswood Chicago Illinois
SKY Integrative Medical Center/SKYCRNG Ridgeland Mississippi
Keystone Clinical Studies Plymouth Meeting Pennsylvania
Eastside Research Associates Redmond Washington
Rainier Clinical Research Center Renton Washington
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06643728 on ClinicalTrials.gov ↗ ← All trials in the USA