A Multiple Dose Escalation Study in Chinese Participants With Overweight BMI or Obesity to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- 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 learn about the safety and tolerability of LY3437943 when given to Chinese participants with overweight body mass index (BMI) or obesity. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last about 20 weeks excluding screening period and may include up to 20 visits to the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For All Participants:
- •Are native Chinese males or females
- •Have a body mass index of ≥27 and ≤40 kilograms per square meter (kg/m²)
- •Have not modified diet or adopted any nutritional lifestyle modification for 3 months
- •Have stable body weight for the last three months
- •Male participants must agree to use contraception during the study and for 4 months afterward and female participants must be woman of nonchildbearing potential
- •For Type 2 Diabetes Mellitus (T2DM) Participants:
- •Have type 2 diabetes for at least 3 months
- •Have a glycated hemoglobin (HbA1c) value of ≥7.0% and ≤10.5% and have been treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
排除标准
- •For All Participants:
- •Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week and smoke more than 10 cigarettes, or cigarette equivalent (as determined by investigator), per day
- •Have other serious or unstable illnesses
- •Have had an episode of severe hypoglycemia
- •Current or chronic history of liver disease.
- •For T2DM Participants:
- •Have type 1 diabetes mellitus
- •Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
- •Any glucose-lowering medications other than metformin within 3 months prior to screening
研究组 & 干预措施
LY3437943
LY3437943 administered subcutaneously (SC)
干预措施: LY3437943 (Drug)
Placebo
Placebo administered SC
干预措施: Placebo (Drug)
结局指标
主要结局
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 through Week 20
A summary of 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
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943(Predose through Day 109)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943(Predose through Day 109)