Clinical trial NCT06901349: A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes
Official title: A Phase 2b 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 With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight
Keywords: Type 2 Diabetes
Muscle
Lean
Fat
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-28
Enrollment: 180
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 see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.


Eligibility criteria: Inclusion Criteria:

* Have type 2 diabetes
* Have a BMI of ≥27 kilograms per square meter (kg/m2)
* 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 type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar state or 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 a history of New York Heart Association (NYHA) Functional Classification III or IV 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 renal impairment
* 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
* 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 36
Secondary outcomes:
measure: Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
timeFrame: Baseline, Week 36
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 36
measure: Percentage of Participants Achieving ≥5% Body Weight Reduction
timeFrame: Baseline, Week 36
measure: Percentage of Participants Achieving ≥10% Body Weight Reduction
timeFrame: Baseline, Week 36
measure: Percentage of Participants Achieving ≥15% Body Weight Reduction
timeFrame: Baseline, Week 36
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 36
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 36
measure: Change from Baseline in Waist-to-Height Ratio (WHtR)
timeFrame: Baseline, Week 36
measure: Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, Week 36
measure: Change from Baseline in Liver Fat by MRI
timeFrame: Baseline, Week 36
measure: Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline, Week 36
measure: Percent Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 36
measure: Percent Change from Baseline in Triglycerides (TG)
timeFrame: Baseline, Week 36
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 36
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab
timeFrame: Predose through Week 52
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma Clinical Trials
state: Arizona
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Long Beach
country: United States
facility: Healthy Brain Clinic
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute
state: Florida
city: Orlando
country: United States
facility: Charter Research - Winter Park
state: Florida
city: The Villages
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Lawrenceville
country: United States
facility: Balanced Life Health Care Solutions/SKYCRNG
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Idaho Falls
country: United States
facility: Family First Medical Center
state: Idaho
city: Newburgh
country: United States
facility: Deaconess Clinic- Gateway
state: Indiana
city: Columbia
country: United States
facility: Kur Research - Columbia Medical
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Kingwood
country: United States
facility: Activian Clinical Research
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
city: Richmond
country: Canada
facility: Richmond Clinical Trials
state: British Columbia
city: Brampton
country: Canada
facility: Centricity Research Brampton Endocrinology
state: Ontario
city: Hamilton
country: Canada
facility: Premier Clinical Trial Network
state: Ontario
city: Niagara Falls
country: Canada
facility: Your Research Network
state: Ontario
city: Pointe-Claire
country: Canada
facility: Centricity Research Pointe-Claire Multispecialty
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Diex Recherche Trois-Rivieres
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Mihama-ku,Chiba City
country: Japan
facility: Tokuyama Clinic
state: Chiba
city: Chigasaki
country: Japan
facility: Hayashi Diabetes Internal Medicine Clinic
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Takai Clinic
state: Kanagawa
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: The Institute of Medical Science, Asahi Life Foundation
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
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: