A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
- Conditions
- Obesity
- Registration Number
- NCT06373146
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Have a body mass index (BMI) of =30 kilogram/square meter (kg/m²) and =40 kg/m²<br><br> - Willing to learn how to self-inject study intervention (visually impaired persons<br> who are not able to perform the injections must have the assistance of a sighted<br> individual trained to inject the study intervention; persons with physical<br> limitations who are not able to perform the injections must have the assistance of<br> an individual trained to inject the study intervention)<br><br> - Male or female contraceptive use by participant should be consistent with local<br> regulations regarding the methods of contraception for those participating in<br> clinical studies.<br><br>Exclusion Criteria:<br><br> - Have a history of diabetes mellitus, including Type 1 Diabetes Mellitus (T1DM) or<br> Type 2 Diabetes Mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma<br><br> - Have a self-reported change (increase or decrease) in body weight >5 kilogram (kg)<br> within 3 months prior to screening<br><br> - Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple<br> endocrine neoplasia (MEN) syndrome type 2<br><br> - Have acute or chronic hepatitis<br><br> - Have a history of an active or untreated malignancy or are in remission from a<br> clinically significant malignancy for less than 5 years
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Percent Change from Baseline in Body Weight
- Secondary Outcome Measures
Name Time Method Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg);Mean Absolute Change from Baseline for Body Weight (kg);Percentage of Participants Who Achieve =5% Body Weight Reduction;Percentage of Participants Who Achieve =10% Body Weight Reduction;Percentage of Participants Who Achieve =15% Body Weight Reduction;Percentage of Participants Who Achieve =20 Body Weight Reduction;Mean Percent Change from Randomization 2 for Body Weight;Mean Change from Randomization 2 for Body Weight (kg);Mean Absolute Change from Randomization 2 for Body Weight (kg);Change from Baseline to Week 24 in CoEQ Scores;Change from Baseline to Week 48 in CoEQ Scores;Change from Baseline in FCQ-T-r Scores;Change from Baseline in FCQ-T-r Scores