BENITIONSClinical Trial Intelligence

A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

1상 완료 NCT06440980

대상 질환Healthy, Obese, Overweight, Obesity
임상 단계1상
스폰서Eli Lilly and Company
상태완료
참여자 수533 명
중재(약물)Orforglipron
시작일2024년 6월 24일
완료일2025년 6월 2일
결과 공개일2026년 7월 17일

요약

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.

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

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) · Nanogram* hours/milliliter (ng*h/ml)

Cohort 1B: 1 mg LY3502970 Capsule QD (First Treatment)80.2 ± 37.8 Nanogram* hours/milliliter (ng*h/ml)
Cohort 1B: 1 mg LY3502970 Capsule QD (Second Treatment)82.1 ± 39.7 Nanogram* hours/milliliter (ng*h/ml)
Cohort 1B: 0.8 mg LY3502970 Tablet QD78.9 ± 36.6 Nanogram* hours/milliliter (ng*h/ml)
Cohort 1B: 3 mg LY3502970 Capsule QD (First Treatment)240 ± 38.8 Nanogram* hours/milliliter (ng*h/ml)
Cohort 1B: 3 mg LY3502970 Capsule QD (Second Treatment)252 ± 39.1 Nanogram* hours/milliliter (ng*h/ml)
Cohort 1B: 2.5 mg LY3502970 Tablet QD247 ± 37.3 Nanogram* hours/milliliter (ng*h/ml)

Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7

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) · Nanogram per milliliter (ng/ml)

Cohort 1B: 1 mg LY3502970 Capsule QD (First Treatment)5.39 ± 37.9 Nanogram per milliliter (ng/ml)
Cohort 1B: 1 mg LY3502970 Capsule QD (Second Treatment)5.60 ± 39.5 Nanogram per milliliter (ng/ml)
Cohort 1B: 0.8 mg LY3502970 Tablet QD5.38 ± 35.9 Nanogram per milliliter (ng/ml)
Cohort 1B: 3 mg LY3502970 Capsule QD (First Treatment)16.2 ± 41.2 Nanogram per milliliter (ng/ml)
Cohort 1B: 3 mg LY3502970 Capsule QD (Second Treatment)16.8 ± 38.8 Nanogram per milliliter (ng/ml)
Cohort 1B: 2.5 mg LY3502970 Tablet QD16.8 ± 37.4 Nanogram per milliliter (ng/ml)

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