A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3841136 Monotherapy, and LY3841136 in Combination With Tirzepatide, in Japanese Participants With Obesity or Overweight
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22
研究概览
简要总结
The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants who agree to contraception requirements
- •Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive
- •Have had a stable weight for the 3 months
排除标准
- •Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
- •Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years
- •Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
- •Have a history of chronic medical conditions involving the heart, liver, or kidneys
- •Have a history of any malignancy within the past 5 years
- •Have a history or presence of a GI disorder
- •Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity
- •Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening
- •For participants in Part B, have previously received tirzepatide within 6 months prior to screening
- •For participants in Part B, have a personal or family history of medullary thyroid carcinoma, or have multiple endocrine neoplasia syndrome type 2
研究组 & 干预措施
Part B: LY3841136 + Tirzepatide-Placebo
LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC
干预措施: Tirzepatide-Placebo (Drug)
Part A: LY3841136
LY3841136 administered subcutaneously (SC)
干预措施: LY3841136 (Drug)
Part A: Placebo
Placebo administered SC
干预措施: LY3841136-Placebo (Drug)
Part B: Tirzepatide + LY3841136-Placebo
Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC
干预措施: LY3841136-Placebo (Drug)
Part B: Tirzepatide + LY3841136-Placebo
Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC
干预措施: Tirzepatide (Drug)
Part B: LY3841136 + Tirzepatide-Placebo
LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC
干预措施: LY3841136 (Drug)
Part B: LY3841136 + Tirzepatide
LY3841136 administered SC along with Tirzepatide administered SC
干预措施: LY3841136 (Drug)
Part B: LY3841136 + Tirzepatide
LY3841136 administered SC along with Tirzepatide administered SC
干预措施: Tirzepatide (Drug)
Part B: LY3841136-Placebo + Tirzepatide-Placebo
Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC
干预措施: LY3841136-Placebo (Drug)
Part B: LY3841136-Placebo + Tirzepatide-Placebo
Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC
干预措施: Tirzepatide-Placebo (Drug)
结局指标
主要结局
Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22
时间窗: Baseline through Week 22
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Part B: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 34
时间窗: Baseline through Week 34
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136(Predose through Week 22)
- Part A PK: Maximum Observed Concentration (Cmax) of LY3841136(Predose through Week 22)
- Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12(Baseline through Week 12)
- Part B PK: AUC of LY3841136 in Combination with Tirzepatide(Predose through Week 34)
- Part B PK: Cmax of LY3841136 in Combination with Tirzepatide(Predose through Week 34)
- Part B PD: Change From Baseline in Body Weight at Week 24(Baseline through Week 24)