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

Conditions

• Healthy
• Obese
• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Orforglipron — DRUG
  Administered orally

Study Details

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.

Key Dates

First listed

Jun 4, 2024

Start date

Jun 24, 2024

Status verified

Jun 2026

Primary completion

Jun 2, 2025

Completion

Jun 2, 2025

Study Design

Enrollment

533 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Part A: LY3502970 QD Oral Administration (Cohort 1A, Sequence 1)
  Participants received LY3502970 orally once daily (QD) across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows: * Period 1: 1 mg (Capsule) * Period 2: Dose Level 2 (Tablet) * Period 3: Dose Level 1 (Tablet) * Period 4: Dose Level 3 (Tablet) * Period 5: 3 mg (Capsule) * Period 6: Dose Level 5 (Tablet) * Period 7: Dose Level 4 (Tablet) * Period 8: Dose Level 6 (Tablet) * Period 9: 6 mg (Capsule) * Period 10: Dose Level 8 (Tablet) * Period 11: Dose Level 7 (Tablet) * Period 12: Dose Level 9 (Tablet)
• Experimental: Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 2)
  Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows: * Period 1: Dose Level 2 (Tablet) * Period 2: 1 mg (Capsule) * Period 3: Dose Level 3 (Tablet) * Period 4: Dose Level 1 (Tablet) * Period 5: Dose Level 5 (Tablet) * Period 6: 3 mg (Capsule) * Period 7: Dose Level 6 (Tablet) * Period 8: Dose Level 4 (Tablet) * Period 9: Dose Level 8 (Tablet) * Period 10: 6 mg (Capsule) * Period 11: Dose Level 9 (Tablet) * Period 12: Dose Level 7 (Tablet)
• Experimental: Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 3)
  Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows: * Period 1: Dose Level 1 (Tablet) * Period 2: Dose Level 3 (Tablet) * Period 3: 1 mg (Capsule) * Period 4: Dose Level 2 (Tablet) * Period 5: Dose Level 4 (Tablet) * Period 6: Dose Level 6 (Tablet) * Period 7: 3 mg (Capsule) * Period 8: Dose Level 5 (Tablet) * Period 9: Dose Level 7 (Tablet) * Period 10: Dose Level 9 (Tablet) * Period 11: 6 mg (Capsule) * Period 12: Dose Level 8 (Tablet)
• Experimental: Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 4)
  Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows: * Period 1: Dose Level 3 (Tablet) * Period 2: Dose Level 1 (Tablet) * Period 3: Dose Level 2 (Tablet) * Period 4: 1 mg (Capsule) * Period 5: Dose Level 6 (Tablet) * Period 6: Dose Level 4 (Tablet) * Period 7: Dose Level 5 (Tablet) * Period 8: 3 mg (Capsule) * Period 9: Dose Level 9 (Tablet) * Period 10: Dose Level 7 (Tablet) * Period 11: Dose Level 8 (Tablet) * Period 12: 6 mg (Capsule)
• Experimental: Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 1)
  Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows: * Period 7: 12 mg (Capsule) * Period 8: Dose Level 11 (Tablet) * Period 9: Dose Level 10 (Tablet) * Period 10: Dose Level 12 (Tablet) * Period 11: 24 mg (Capsule) * Period 12: Dose Level 14 (Tablet) * Period 13: Dose Level 13 (Tablet) * Period 14: Dose Level 16 (Tablet) * Period 15: 36 mg (Capsule) * Period 16: Dose Level 17 (Tablet) * Period 17: Dose Level 15 (Tablet) * Period 18: Dose Level 18 (Tablet)
• Experimental: Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 2)
  Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows: * Period 7: Dose Level 11 (Tablet) * Period 8: 12 mg (Capsule) * Period 9: Dose Level 12 (Tablet) * Period 10: Dose Level 10 (Tablet) * Period 11: Dose Level 14 (Tablet) * Period 12: 24 mg (Capsule) * Period 13: Dose Level 16 (Tablet) * Period 14: Dose Level 13 (Tablet) * Period 15: Dose Level 17 (Tablet) * Period 16: 36 mg (Capsule) * Period 17: Dose Level 18 (Tablet) * Period 18: Dose Level 15 (Tablet)
• Experimental: Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 3)
  Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows: * Period 7: Dose Level 10 (Tablet) * Period 8: Dose Level 12 (Tablet) * Period 9: 12 mg (Capsule) * Period 10: Dose Level 11 (Tablet) * Period 11: Dose Level 13 (Tablet) * Period 12: Dose Level 16 (Tablet) * Period 13: 24 mg (Capsule) * Period 14: Dose Level 14 (Tablet) * Period 15: Dose Level 15 (Tablet) * Period 16: Dose Level 18 (Tablet) * Period 17: 36 mg (Capsule) * Period 18: Dose Level 17 (Tablet)
• Experimental: Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 4)
  Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows: * Period 7: Dose Level 12 (Tablet) * Period 8: Dose Level 10 (Tablet) * Period 9: Dose Level 11 (Tablet) * Period 10: 12 mg (Capsule) * Period 11: Dose Level 16 (Tablet) * Period 12: Dose Level 13 (Tablet) * Period 13: Dose Level 14 (Tablet) * Period 14: 24 mg (Capsule) * Period 15: Dose Level 18 (Tablet) * Period 16: Dose Level 15 (Tablet) * Period 17: Dose Level 17 (Tablet) * Period 18: 36 mg (Capsule)
• Experimental: Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 1)
  Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows: * Period 1: 1 mg (Capsule- First Treatment) * Period 2: 1 mg (Capsule- Second Treatment) * Period 3: 0.8 mg (Tablet) * Period 4: 3 mg (Capsule- First Treatment) * Period 5: 3 mg (Capsule- Second Treatment) * Period 6: 2.5 mg (Tablet) * Period 7: 6 mg (Capsule- First Treatment) * Period 8: 6 mg (Capsule- Second Treatment) * Period 9: 5.5 mg (Tablet)
• Experimental: Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 2)
  Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows: * Period 1: 1 mg (Capsule- First Treatment) * Period 2: 0.8 mg (Tablet) * Period 3: 1 mg (Capsule- Second Treatment) * Period 4: 3 mg (Capsule- First Treatment) * Period 5: 2.5 mg (Tablet) * Period 6: 3 mg (Capsule- Second Treatment) * Period 7: 6 mg (Capsule- First Treatment) * Period 8: 5.5 mg (Tablet) * Period 9: 6 mg (Capsule- Second Treatment)
• Experimental: Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 3)
  Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows: * Period 1: 0.8 mg (Tablet) * Period 2: 1 mg (Capsule- First Treatment) * Period 3: 1 mg (Capsule- Second Treatment) * Period 4: 2.5 mg (Tablet) * Period 5: 3 mg (Capsule- First Treatment) * Period 6: 3 mg (Capsule- Second Treatment) * Period 7: 5.5 mg (Tablet) * Period 8: 6 mg (Capsule- First Treatment) * Period 9: 6 mg (Capsule- Second Treatment)
• Experimental: Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 1)
  Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows: * Period 7: 12 mg (Capsule- First Treatment) * Period 8: 12 mg (Capsule- Second Treatment) * Period 9: 9 mg (Tablet) * Period 10: 24 mg (Capsule- First Treatment) * Period 11: 24 mg (Capsule- Second Treatment) * Period 12: 14.5 mg (Tablet) * Period 13: 36 mg (Capsule- First Treatment) * Period 14: 36 mg (Capsule- Second Treatment) * Period 15: 17.2 mg (Tablet)
• Experimental: Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 2)
  Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows: * Period 7: 12 mg (Capsule- First Treatment) * Period 8: 9 mg (Tablet) * Period 9: 12 mg (Capsule- Second Treatment) * Period 10: 24 mg (Capsule- First Treatment) * Period 11: 14.5 mg (Tablet) * Period 12: 24 mg (Capsule- Second Treatment) * Period 13: 36 mg (Capsule- First Treatment) * Period 14: 17.2 mg (Tablet) * Period 15: 36 mg (Capsule- Second Treatment)
• Experimental: Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 3)
  Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg \[Capsule\]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows: * Period 7: 9 mg (Tablet) * Period 8: 12 mg (Capsule- First Treatment) * Period 9: 12 mg (Capsule- Second Treatment) * Period 10: 14.5 mg (Tablet) * Period 11: 24 mg (Capsule- First Treatment) * Period 12: 24 mg (Capsule- Second Treatment) * Period 13: 17.2 mg (Tablet) * Period 14: 36 mg (Capsule- First Treatment) * Period 15: 36 mg (Capsule- Second Treatment)

Primary Outcome Measure

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 [ Time Frame: 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) ]

Locations (7)

Related coverage on Hipa.ai

• Orforglipron PK Study in Obese/Overweight Shows Similar Capsule/Tablet Exposure
  Orforglipron · Jul 17, 2026 · ClinicalTrials.gov

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