A Phase 1, Open-Label, Multiple-Dose Study to Investigate the Comparability of the Pharmacokinetics of Orforglipron (LY3502970) Single Capsule and Multiple Capsules in Healthy Participants (J2A-JE-GZPM)

Eli Lilly Japan K.K.0 个研究点目标入组 80 人开始时间: 待定最近更新: 2025年3月5日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Eli Lilly Japan K.K.
入组人数: 80
主要终点: Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State)

暂无简介。

•Have a stable body weight, that is, less than a 5% body weight change, for 1 month prior to randomization and body mass index (BMI) within the range 23.0 to 35.0 kilogram per square meter (kg/m2), inclusive
•Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
•Have venous access sufficient to allow for blood sampling
•Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

•Have a hemoglobin A1c (HbA1c) test level greater than or equal to 6.5%
•Have an estimated glomerular filtration rate less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73m2)
•Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder, for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder within the 2 years prior to screening
•Actively suicidal and therefore deemed to be at significant risk for suicide
•Have a known clinically significant gastric emptying abnormality
•Have history or presence of acute or chronic pancreatitis or an elevation in serum lipase or amylase levels greater than 3 times the upper limit of normal (ULN)
•Have an abnormal blood pressure (BP), pulse rate, or both
•Have difficulty swallowing capsules

Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State)

时间窗: Week 3 Through Week 16

Pharmacokinetics (PK): Steady-state AUC of Orforglipron (Fasted State)

未报告次要终点

发起方