A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
第1相
完了
NCT05841238
| 対象疾患 | Healthy, Obese |
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| 相 | 第1相 |
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| スポンサー | Eli Lilly and Company |
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| ステータス | 完了 |
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| 参加者数 | 52 名 |
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| 介入（薬剤） | LY3502970 |
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| 開始日 | 2023年4月26日 |
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| 完了日 | 2023年9月14日 |
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| 結果公開日 | 2026年7月10日 |
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概要
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) |
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| Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State) | 199 ± 34 nanogram*hour per milliliter (ng*h/mL) |
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| Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State) | 294 ± 31 nanogram*hour per milliliter (ng*h/mL) |
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| Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State) | 548 ± 29 nanogram*hour per milliliter (ng*h/mL) |
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| Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State) | 700 ± 42 nanogram*hour per milliliter (ng*h/mL) |
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| Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State) | 1080 ± 32 nanogram*hour per milliliter (ng*h/mL) |
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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) |
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| Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State) | 13.5 ± 39 nanograms per milliliter (ng/mL) |
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| Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State) | 19.9 ± 34 nanograms per milliliter (ng/mL) |
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| Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State) | 36.6 ± 35 nanograms per milliliter (ng/mL) |
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| Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State) | 45.1 ± 49 nanograms per milliliter (ng/mL) |
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| Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State) | 69.8 ± 34 nanograms per milliliter (ng/mL) |
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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 |
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| Part A: Period 2 (Day 8-14): 2 mg LY3502970 Capsule (Fasted State) | 6.00 hours |
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| Part A: Period 3 (Day 15-21): 2.5 mg LY3502970 Tablet (Fasted State) | 6.00 hours |
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| Part A: Period 4 (Day 22-28): 5 mg LY3502970 Tablet (Fasted State) | 6.00 hours |
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| Part A: Period 5 (Day 29-35): 8 mg LY3502970 Capsule (Fasted State) | 8.00 hours |
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| Part A: Period 6 (Day 36-42): 10 mg LY3502970 Tablet (Fasted State) | 6.00 hours |
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