A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 533
- 试验地点
- 12
- 主要终点
- Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to τ hour time point AUC(0-τ) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths
研究概览
简要总结
The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated.
The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the 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
- 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
- •Participants who are overtly healthy as determined by medical history and physical examination.
- •Have a stable body weight for one month prior to screening (less than or equal to 5 percent body weight gain or loss) and Body Mass Index (BMI) in range of 27 to 40 kilogram per meter square (kg/m²).
- •Participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- •Have venous access sufficient to allow for blood sampling.
排除标准
- •Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
- •Have a history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or other significant active, uncontrolled medical conditions.
- •Have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years.
- •Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome.
- •Have known clinically significant gastric emptying abnormality.
- •Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
- •Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer.
- •Have an abnormal 12-lead electrocardiogram (ECG) at screening.
- •Have history of pancreatitis.
- •Judged by the study investigator to be at serious suicidal risk and have answered "Yes" to either question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
- •Have difficulty swallowing capsules or tablets.
研究组 & 干预措施
Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron
Participants will receive different sequences of orforglipron doses administered as either tablet or capsule at different dose levels.
干预措施: Orforglipron (Drug)
Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron
Participants will receive different sequences of orforglipron doses administered as either tablet (different dose levels) or capsule (test dose levels 1 to 6).
干预措施: Orforglipron (Drug)
结局指标
主要结局
Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to τ hour time point AUC(0-τ) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths
时间窗: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
τ is 24 hours for once daily (QD) dosing
Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths
时间窗: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Part B: Pharmacokinetics (PK): Steady-state Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau]) of LY3502970 on Day 7
时间窗: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
PK: Area under the concentration versus time curve from time 0 to the end of the once daily dosing interval at steady state AUC\[0-tau\] on Day 7.
Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7
时间窗: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
PK: Maximum concentration of LY3502970 during a once daily dosing interval at steady state on Day 7.
次要结局
- Part B: PK: Steady-state AUC(0-τ) of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths(Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2))
- Part B: PK: Steady-state Cmax of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths(Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2))