A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study of Once-Weekly Tirzepatide Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 34
- 主要终点
- Mean Percent Change from Baseline in Body Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
TZP + Mibavademab-placebo (MIBA-PBO) [Group B]
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.
干预措施: Mibavademab-Placebo (Drug)
Tirzepatide (TZP) + Mibavademab (MIBA) [Group A]
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.
干预措施: Mibavademab (Drug)
Tirzepatide (TZP) + Mibavademab (MIBA) [Group A]
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.
干预措施: Tirzepatide (Drug)
TZP + Mibavademab-placebo (MIBA-PBO) [Group B]
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.
干预措施: Tirzepatide (Drug)
TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C]
Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.
干预措施: Tirzepatide-Placebo (Drug)
TZP + MIBA-PBO [Group E]
Participants will receive TZP SC + MIBA-PBO SC for 48 weeks.
干预措施: Mibavademab-Placebo (Drug)
TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C]
Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.
干预措施: Tirzepatide (Drug)
TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C]
Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.
干预措施: Mibavademab (Drug)
TZP + MIBA [Group D]
Participants will receive TZP SC + MIBA SC for 48 weeks.
干预措施: Tirzepatide (Drug)
TZP + MIBA-PBO [Group E]
Participants will receive TZP SC + MIBA-PBO SC for 48 weeks.
干预措施: Tirzepatide (Drug)
TZP + MIBA [Group D]
Participants will receive TZP SC + MIBA SC for 48 weeks.
干预措施: Mibavademab (Drug)
TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.
干预措施: Mibavademab (Drug)
TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.
干预措施: Tirzepatide-Placebo (Drug)
TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.
干预措施: Mibavademab-Placebo (Drug)
TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.
干预措施: Tirzepatide-Placebo (Drug)
TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.
干预措施: Mibavademab-Placebo (Drug)
TZP + MIBA-PBO then TZP + MIBA [Group G]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks.
干预措施: Mibavademab-Placebo (Drug)
TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.
干预措施: Tirzepatide (Drug)
TZP + MIBA-PBO then TZP + MIBA [Group G]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks.
干预措施: Tirzepatide (Drug)
TZP + MIBA-PBO then TZP + MIBA [Group G]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks.
干预措施: Mibavademab (Drug)
TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H]
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Mean Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 48
次要结局
- Change from Baseline to Week 48 in CoEQ Scores(Baseline, Week 48)
- Change from Baseline in FCQ-T-r Scores(Baseline, Week 48)
- 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)
- 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)
- Change from Baseline in FCQ-T-r Scores(Baseline, Week 24)