Obesity, Overweight
Conditions
Keywords
Muscle, Lean, Fat
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.
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Outcome results
None listed