A Phase 1, Investigator- and Participant-Blinded, Placebo Controlled, Randomized, Single Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Eloralintide (LY3841136) in Chinese Participants With Obesity or Overweight
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 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 purpose of this study is to evaluate how well Eloralintide (LY3841136) is tolerated and what side effects may occur in overweight and obese Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much Eloralintide gets into the bloodstream and how long it takes the body to eliminate it.
The study will last approximately 10 weeks excluding a 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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese participants. To qualify as Chinese, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
- •Have had a stable body weight for 3 months prior to screening. Participants with body weight change of less than 5% will be allowed
- •Have not modified diet or adopted any nutritional lifestyle modification for 3 months before randomization
- •Have clinical laboratory test results within a normal range for the population or investigative site at screening and lead-in, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- •Have a body mass index (BMI) within the range 27 to 40 kilogram per square meter (kg/m²)
排除标准
- •Are pregnant, or intend to become pregnant or to breastfeed during the study
- •Have known allergies to related compounds of eloralintide
- •Have any of the following abnormal blood pressure (BP) and/or pulse rate at screening, constituting a risk when taking the investigational product with minor deviations judged to be acceptable by the investigator:
- •Supine BP > 160/90 millimeter mercury (mmHg)
- •Supine pulse rate < 50 or > 100 beats per minute (bpm)
- •Orthostatic hypotension
- •Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Regularly use known drugs of abuse and/or show positive findings on drug screening that are not consistent with the medical history or concomitant medication history
- •Have donated blood of more than 450 mL within the previous 3 months of study screening, or intend to donate blood during the course of the study
- •Have a history of chronic medical conditions involving the heart, liver, or kidneys
- •Have a medical history or current evidence of clinically significant cardiac condition
研究组 & 干预措施
Eloralintide
Eloralintide administered subcutaneously (SC)
干预措施: Eloralintide (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 to Study Completion (Up to 10 Weeks)
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Eloralintide(Baseline to Study Completion (Up to 10 Weeks))
- PK: Area Under the Concentration Versus Time Curve (AUC) of Eloralintide(Baseline to Study Completion (Up to 10 Weeks))