Clinical trial NCT06643728: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight
Keywords: Muscle
Lean
Fat
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
timeFrame: Baseline, Week 24, Week 48
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 24, Week 48
measure: Percentage of Participants Achieving ≥5% Body Weight Reduction
timeFrame: Baseline, Week 24, Week 48
measure: Percentage of Participants Achieving ≥10% Body Weight Reduction
timeFrame: Baseline, Week 24, Week 48
measure: Percentage of Participants Achieving ≥15% Body Weight Reduction
timeFrame: Baseline, Week 24, Week 48
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 24, Week 48
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 24, Week 48
measure: Change from Baseline in Waist-to-Height Ratio (WHtR)
timeFrame: Baseline, Week 24, Week 48
measure: Percent Change from Baseline in Visceral Adipose Tissue (VAT)
timeFrame: Baseline, Week 24, Week 48
measure: Percent Change from Baseline in Total Body Lean Mass by DXA
timeFrame: Baseline, Week 24, Week 48
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: Central Research Associates
state: Alabama
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies
state: Pennsylvania
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: