A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Anaheim, California, United States, 92801
- Anaheim Clinical Trials, LLC
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Los Alamitos, California, United States, 90720
- Collaborative Neuroscience Research, LLC
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Florida
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Daytona Beach, Florida, United States, 32117
- Fortrea Clinical Research Unit
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Kansas
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Overland Park, Kansas, United States, 66212
- Altasciences Company Inc.
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Missouri
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Springfield, Missouri, United States, 65802
- QPS
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Texas
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Dallas, Texas, United States, 75247
- Fortrea Clinical Research Unit
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Wisconsin
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Madison, Wisconsin, United States, 53704
- Fortrea Clinical Research Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants who are overtly healthy as determined by medical history and physical examination.
- Have a stable body weight for one month prior to screening (less than or equal to 5 percent body weight gain or loss) and Body Mass Index (BMI) in range of 27 to 40 kilogram per meter square (kg/m²).
- Participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Have venous access sufficient to allow for blood sampling.
Exclusion Criteria:
- Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
- Have a history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or other significant active, uncontrolled medical conditions.
- Have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years.
- Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome.
- Have known clinically significant gastric emptying abnormality.
- Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
- Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer.
- Have an abnormal 12-lead electrocardiogram (ECG) at screening.
- Have history of pancreatitis.
- Judged by the study investigator to be at serious suicidal risk and have answered "Yes" to either question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
- Have difficulty swallowing capsules or tablets.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
|
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:
|
Administered orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
PK: Area under the concentration versus time curve from time 0 to the end of the once daily dosing interval at steady state AUC[0-tau] 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)
|
|
Part B: PK: Steady-state Maximum Observed Concentration (Cmax) 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)
|
PK: Maximum concentration of LY3502970 during a once daily dosing interval at steady state 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Part B: PK: Steady-state AUC(0-τ) of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths
Time Frame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
|
τ is 24 hours for QD dosing
|
Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
|
|
Part B: PK: Steady-state Cmax of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths
Time Frame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
|
Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18617
- J2A-MC-GZPI (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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