A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
Phase 1
Completed
NCT06440980
| Condition | Healthy, Obese, Overweight, Obesity |
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| Phase | Phase 1 |
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| Sponsor | Eli Lilly and Company |
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| Status | Completed |
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| Enrollment | 533 participants |
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| Interventions | Orforglipron |
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| Start date | Jun 24, 2024 |
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| Completion date | Jun 2, 2025 |
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| Results posted | Jul 17, 2026 |
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Summary
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) |
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| Cohort 1B: 1 mg LY3502970 Capsule QD (Second Treatment) | 82.1 ± 39.7 Nanogram* hours/milliliter (ng*h/ml) |
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| Cohort 1B: 0.8 mg LY3502970 Tablet QD | 78.9 ± 36.6 Nanogram* hours/milliliter (ng*h/ml) |
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| Cohort 1B: 3 mg LY3502970 Capsule QD (First Treatment) | 240 ± 38.8 Nanogram* hours/milliliter (ng*h/ml) |
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| Cohort 1B: 3 mg LY3502970 Capsule QD (Second Treatment) | 252 ± 39.1 Nanogram* hours/milliliter (ng*h/ml) |
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| Cohort 1B: 2.5 mg LY3502970 Tablet QD | 247 ± 37.3 Nanogram* hours/milliliter (ng*h/ml) |
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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) |
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| Cohort 1B: 1 mg LY3502970 Capsule QD (Second Treatment) | 5.60 ± 39.5 Nanogram per milliliter (ng/ml) |
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| Cohort 1B: 0.8 mg LY3502970 Tablet QD | 5.38 ± 35.9 Nanogram per milliliter (ng/ml) |
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| Cohort 1B: 3 mg LY3502970 Capsule QD (First Treatment) | 16.2 ± 41.2 Nanogram per milliliter (ng/ml) |
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| Cohort 1B: 3 mg LY3502970 Capsule QD (Second Treatment) | 16.8 ± 38.8 Nanogram per milliliter (ng/ml) |
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| Cohort 1B: 2.5 mg LY3502970 Tablet QD | 16.8 ± 37.4 Nanogram per milliliter (ng/ml) |
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