A Parallel-Group, Double-Blind Study to Investigate the Safety and Tolerability of LY3549492 Compared With Placebo in Adult Participants Aged 55 to 80 Years With a BMI of 22 to 25 kg/m2
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 19
- 主要终点
- Number of Participants with One or More Serious Adverse Events (SAE) 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 LY3549492 in adult participants with a healthy body max index (BMI) of 22 to 25 kilograms per square meter (kg/m2).
Participation in the study will last about 13 months.
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
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI) within the range of 22 to 25 kilograms per square meter (kg/m2)
- •Have had a stable body weight for 3 months prior to screening
排除标准
- •Have type 1 diabetes, latent autoimmune diabetes in adults, or a history of ketoacidosis or hyperosmolar coma
- •type 2 diabetes and on antidiabetic therapy (except type 2 diabetes being managed with diet and/or stable dose of metformin)
- •rare forms of diabetes mellitus, or
- •hemoglobin A1c (HbA1c) >8%
- •Have poorly controlled hypertension
- •Have any of the following cardiovascular conditions within 12 months prior to screening:
- •acute myocardial infarction
- •unstable angina, or
- •hospitalization due to congestive heart failure.
- •Have a history of New York Heart Association Functional Classification III or IV congestive heart failure
- •Have signs and symptoms of liver disease
- •Have a history of pancreatitis
- •Have taken medications or alternative remedies for weight loss or weight gain within 3 months prior to screening
研究组 & 干预措施
LY3549492 Dose 1
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 Dose 2
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
Placebo
Participants will receive placebo orally
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Week 48
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
- Percent Change from Baseline in Body Weight(Baseline, Week 24, Week 48)
- Number of Participants with Adverse Events Leading to Permanent Discontinuation of Study Intervention or Withdrawal(Baseline through Week 48)