Obesity, Overweight
Conditions
Keywords
Type 2 Diabetes, Muscle, Lean, Fat
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 36 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 36 |
| Percentage of Participants Achieving ≥5% Body Weight Reduction | Baseline, Week 36 |
| Percentage of Participants Achieving ≥10% Body Weight Reduction | Baseline, Week 36 |
| Percentage of Participants Achieving ≥15% Body Weight Reduction | Baseline, Week 36 |
| Change from Baseline in Waist Circumference | Baseline, Week 36 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 36 |
| Change from Baseline in Waist-to-Height Ratio (WHtR) | Baseline, Week 36 |
| Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA) | Baseline, Week 36 |
| Change from Baseline in Liver Fat by MRI | Baseline, Week 36 |
| Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 36 |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 36 |
| Percent Change from Baseline in Triglycerides (TG) | Baseline, Week 36 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 36 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab | Predose through Week 52 |
| Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI) | Baseline, Week 36 |
Countries
Argentina, Canada, China, Japan, United States
Outcome results
None listed