A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
1期
已完成
NCT05841238
| 适应症 | Healthy, Obese |
|---|
| 分期 | 1期 |
|---|
| 申办方 | Eli Lilly and Company |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 52 人 |
|---|
| 干预（药物） | LY3502970 |
|---|
| 开始日期 | 2023年4月26日 |
|---|
| 完成日期 | 2023年9月14日 |
|---|
| 结果公布日 | 2026年7月10日 |
|---|
摘要
The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13 · nanogram*hour per milliliter (ng*h/mL)
| Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State) | 90.8 ± 27 nanogram*hour per milliliter (ng*h/mL) |
|---|
| Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State) | 199 ± 34 nanogram*hour per milliliter (ng*h/mL) |
|---|
| Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State) | 294 ± 31 nanogram*hour per milliliter (ng*h/mL) |
|---|
| Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State) | 548 ± 29 nanogram*hour per milliliter (ng*h/mL) |
|---|
| Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State) | 700 ± 42 nanogram*hour per milliliter (ng*h/mL) |
|---|
| Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State) | 1080 ± 32 nanogram*hour per milliliter (ng*h/mL) |
|---|
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13 · nanograms per milliliter (ng/mL)
| Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State) | 6.08 ± 26 nanograms per milliliter (ng/mL) |
|---|
| Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State) | 13.5 ± 39 nanograms per milliliter (ng/mL) |
|---|
| Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State) | 19.9 ± 34 nanograms per milliliter (ng/mL) |
|---|
| Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State) | 36.6 ± 35 nanograms per milliliter (ng/mL) |
|---|
| Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State) | 45.1 ± 49 nanograms per milliliter (ng/mL) |
|---|
| Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State) | 69.8 ± 34 nanograms per milliliter (ng/mL) |
|---|
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13 · hours
| Part A: Period 1 (Day 1-7): 0.8 mg LY3502970 Tablet (Fasted State) | 6.00 hours |
|---|
| Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State) | 6.00 hours |
|---|
| Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State) | 6.00 hours |
|---|
| Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State) | 6.00 hours |
|---|
| Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State) | 8.00 hours |
|---|
| Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State) | 6.00 hours |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。