NCT07073170已完成1 期
A Phase 1, Participant- and Investigator-Blind, Placebo-Controlled, Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Daily Doses of LY3549492 in Chinese Participants With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 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 investigate LY3549492 in Chinese participants with type 2 diabetes. Participation in the study will last about 18 weeks.
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
- •Are native Chinese
- •Have type 2 diabetes for at least 6 months
- •Have been treated with diet and exercise, with or without a stable dose of metformin for at least 3 months
- •Have hemoglobin A1c (HbA1c) of at least 7% and no greater than 10%
- •Have a body mass index (BMI) of at least 20 milligrams per square meter (kg/m2) and no greater than 40 kg/m2
- •Have had a stable body weight for the 3 months prior to screening
- •Women must not be of childbearing potential
排除标准
- •Have type 1 diabetes or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization
- •Have had an episode of severe hypoglycemia within 6 months or have a history of hypoglycemia unawareness
- •Have a clinically significant gastric emptying abnormality
- •Have or have a history of pancreatitis
- •Have signs and symptoms of liver disease, with the exception of non-alcoholic fatty liver disease
- •Have a personal or family history of multiple endocrine neoplasia syndrome type 2 or medullary thyroid carcinoma
- •Have an uncontrolled endocrine abnormality
- •Have an abnormal blood pressure or pulse rate
- •Have a 12-lead electrocardiogram (ECG) abnormality
- •Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study intervention, or of interfering with the interpretation of data
研究组 & 干预措施
LY3549492 Dose 1
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 Dose 2
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
LY3549492 Dose 3
Experimental
Participants will receive LY3549492 orally
干预措施: LY3549492 (Drug)
Placebo
Placebo Comparator
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 14
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
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3549492(Predose through Week 13)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492(Predose through Week 13)
研究者
研究点 (3)
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