A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
Phase 2
Active, not recruiting
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT06373146
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 360
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C] Mibavademab Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks. TZP + MIBA-PBO then TZP + MIBA [Group G] Mibavademab Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks. TZP + MIBA-PBO [Group E] Tirzepatide Participants will receive TZP SC + MIBA-PBO SC for 48 weeks. TZP + MIBA-PBO [Group E] Mibavademab-Placebo Participants will receive TZP SC + MIBA-PBO SC for 48 weeks. TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C] Tirzepatide-Placebo Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks. TZP + MIBA [Group D] Tirzepatide Participants will receive TZP SC + MIBA SC for 48 weeks. Tirzepatide (TZP) + Mibavademab (MIBA) [Group A] Tirzepatide Participants will receive TZP subcutaneously (SC) and MIBA for 24 weeks. Participants in Group A will be randomized (Randomization 2) to groups C and D at week 24. Tirzepatide (TZP) + Mibavademab (MIBA) [Group A] Mibavademab Participants will receive TZP subcutaneously (SC) and MIBA for 24 weeks. Participants in Group A will be randomized (Randomization 2) to groups C and D at week 24. TZP + Mibavademab-placebo (MIBA-PBO) [Group B] Mibavademab-Placebo Participants will receive TZP SC and MIBA-PBO SC for 24 weeks. Participants in Group B will be randomized (Randomization 2) to Groups E, F, G, and H at week 24. TZP + MIBA [Group D] Mibavademab Participants will receive TZP SC + MIBA SC for 48 weeks. TZP + MIBA-PBO then TZP-PBO + MIBA [Group F] Mibavademab Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks. TZP + MIBA-PBO then TZP-PBO + MIBA [Group F] Tirzepatide-Placebo Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks. TZP + MIBA-PBO then TZP-PBO + MIBA [Group F] Mibavademab-Placebo Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks. TZP + MIBA-PBO then TZP + MIBA [Group G] Mibavademab-Placebo Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks. TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H] Tirzepatide-Placebo Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks. TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H] Mibavademab-Placebo Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks. TZP + Mibavademab-placebo (MIBA-PBO) [Group B] Tirzepatide Participants will receive TZP SC and MIBA-PBO SC for 24 weeks. Participants in Group B will be randomized (Randomization 2) to Groups E, F, G, and H at week 24. TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C] Tirzepatide Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks. TZP + MIBA-PBO then TZP-PBO + MIBA [Group F] Tirzepatide Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks. TZP + MIBA-PBO then TZP + MIBA [Group G] Tirzepatide Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks. TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H] Tirzepatide Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.
- Primary Outcome Measures
Name Time Method Mean Percent Change from Baseline in Body Weight Baseline, Week 48
- Secondary Outcome Measures
Name Time Method Mean Absolute Change from Baseline for Body Weight (kg) Baseline, 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 48 Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg) Baseline, Week 24 Percentage of Participants Who Achieve ≥5% Body Weight Reduction Baseline to Week 48 Percentage of Participants Who Achieve ≥20 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 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
Trial Locations
- Locations (17)
Velocity Clinical Research, Gardena
🇺🇸Gardena, California, United States
Irvine Clinical Research
🇺🇸Irvine, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Velocity Clinical Research, North Hollywood
🇺🇸North Hollywood, California, United States
Velocity Clinical Research, Santa Ana
🇺🇸Santa Ana, California, United States
Velocity Clinical Research, Panorama City
🇺🇸Van Nuys, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Velocity Clinical Research - New Orleans
🇺🇸New Orleans, Louisiana, United States
Hassman Research Institute Marlton Site
🇺🇸Marlton, New Jersey, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
South Texas Clinical Research
🇺🇸Corpus Christi, Texas, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States