Obesity
Conditions
Keywords
Glucagon-like peptide-1 (GLP-1), Leptin, Incretin, Weight maintenance
Brief summary
The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.
Interventions
DRUGTirzepatide
Administered SC
DRUGMibavademab
Administered SC
Administered SC
DRUGMibavademab-Placebo
Administered SC
Sponsors
Eli Lilly and Company
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a body mass index (BMI) of ≥30 kilogram/square meter (kg/m²) and ≤40 kg/m² * Willing to learn how to self-inject study intervention (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study intervention; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study intervention) * Male or female contraceptive use by participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
* Have a history of diabetes mellitus, including Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma * Have a self-reported change (increase or decrease) in body weight \>5 kilogram (kg) within 3 months prior to screening * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2 * Have acute or chronic hepatitis * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Change from Baseline in Body Weight | Baseline, Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg) | Baseline, Week 24 |
| Mean Absolute Change from Baseline for Body Weight (kg) | Baseline, Week 48 |
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Baseline to Week 48 |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Baseline to Week 48 |
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Baseline to Week 48 |
| Percentage of Participants Who Achieve ≥20 Body Weight Reduction | Baseline to Week 48 |
| Mean Percent Change from Randomization 2 for Body Weight | Week 24, Week 48 |
| Mean Change from Randomization 2 for Body Weight (kg) | Week 24, Week 48 |
| Mean Absolute Change from Randomization 2 for Body Weight (kg) | Week 24, Week 48 |
| Change from Baseline to Week 24 in CoEQ Scores | Baseline, Week 24 |
| Change from Baseline to Week 48 in CoEQ Scores | Baseline, Week 48 |
| Change from Baseline in FCQ-T-r Scores | Baseline, Week 24 |
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