BENITIONSClinical Trial Intelligence

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

Фаза 1 Завершено NCT06440980

ЗаболеваниеHealthy, Obese, Overweight, Obesity
ФазаФаза 1
СпонсорEli Lilly and Company
СтатусЗавершено
Участники533 участн.
ВмешательствоOrforglipron
Дата начала24.06.2024
Дата завершения2.06.2025
Публикация результатов17.07.2026

Кратко

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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