A Dose-Escalation Phase 1, Investigator- and Participant-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3532226 in Participants With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period. Part C of the study will last approximately 8 weeks, excluding the screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (BMI) within the range of 30 to 40 kilogram per square meter (kg/m²)
- •Have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment
排除标准
- •Have a lifetime history of a suicide attempt
- •Have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years
- •Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire
- •Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery
- •Have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier
- •Intend to use any weight-loss medications during study participation
- •Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
研究组 & 干预措施
LY3532226 (Part A)
LY3532226 administered subcutaneously (SC)
干预措施: LY3532226 (Drug)
Placebo (Part A)
Placebo administered SC
干预措施: Placebo (Drug)
LY3532226 (Part B)
LY3532226 administered SC
干预措施: LY3532226 (Drug)
Placebo (Part B)
Placebo administered SC
干预措施: Placebo (Drug)
LY3532226 (Part C)
LY3532226 administered SC
干预措施: LY3532226 (Drug)
Placebo (Part C)
Placebo administered SC
干预措施: Placebo (Drug)
结局指标
主要结局
Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline to Study Completion (Up to 16 Weeks)
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part B: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline to Study Completion (Up to 20 Weeks)
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Part C: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline to Study Completion (Up to 8 Weeks)]
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Part B: PK: AUC of LY3532226(Predose on Day 1 through Week 20)
- Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226(Predose on Day 1 through Week 16)
- Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226(Predose on Day 1 through Week 16)
- Part B: PK: Cmax of LY3532226(Predose on Day 1 through Week 20)
- Part C: Pharmacodynamic (PD): Change in insulin sensitivity index (Si)(Baseline up to Approximately Week 4)