NCT07232732已完成1 期
A Phase-1, Parallel-Design, Open-Label, Randomized, Multiple-Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3549492 in Healthy Participants With Overweight or Obesity
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
- 120
- 试验地点
- 3
- 主要终点
- Number of Participants with One or More 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 purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy people who are overweight or have obesity. Participation in the study will last approximately 8 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
- None
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
- 是
入选标准
- •Have a hemoglobin A1c level of less than 6.5 percent (%) at screening.
- •Have a body mass index (BMI) of 25.0 to 45.0 kilogram per square meter (kg/m²), inclusive, at screening
- •Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individual of childbearing potential (INOCBP) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader Willi syndrome.
- •Have any of the following conditions at screening,
- •supine systolic blood pressure of 160 millimeter of mercury (mmHg) or greater
- •supine diastolic blood pressure of 100 mmHg or greater, or
- •resting pulse rate of greater than 95 beats per minute (bpm) or less than 45 bpm. (Note: white-coat hypertension is excluded; therefore, if a repeated measurement of blood pressure after at least 5 minutes shows values within the range, the participant can be included).
- •Have had any of the following within 6-months prior to screening
- •myocardial infarction
- •unstable angina
- •coronary artery bypass graft
- •percutaneous coronary intervention. (Note: diagnostic angiograms are permitted)
- •transient ischemic attack
- •cerebrovascular accident or decompensated congestive heart failure, or
- •New York Health Association Class III or IV heart failure.
- •Have serum triglyceride of 5 millimoles per liter (mmol/L) or greater (442 milligrams per deciliter [mg/dL]) at screening
- •Have had any exposure to glucagon-like peptide-1 (GLP-1) analogs or other related compounds within the 3 months prior to screening
研究组 & 干预措施
LY3549492 (Treatment Group 2)
Experimental
LY3549492 administered orally.
干预措施: LY3549492 (Drug)
LY3549492 (Treatment Group 4)
Experimental
LY3549492 administered orally.
干预措施: LY3549492 (Drug)
LY3549492 (Treatment Group 1)
Experimental
LY3549492 administered orally.
干预措施: LY3549492 (Drug)
LY3549492 (Treatment Group 3)
Experimental
LY3549492 administered orally.
干预措施: LY3549492 (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through end of the Follow-up Period (Week 10)
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3549492(Predose on Day 1 through end of the Follow-up Period (Week 10))
- PK: Observed Drug Trough Concentration (Ctrough) of LY3549492(Predose on Day 1 through end of the Follow-up Period (Week 10))
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492(Predose on Day 1 through end of the Follow-up Period (Week 10))
研究者
研究点 (3)
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