Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
133 participants
INTERVENTIONAL
2019-06-12
2020-11-02
Brief Summary
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* The safety of LY3502970 and any side effects that might be associated with it.
* How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it.
This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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LY3502970 (Part A)
Single dose of LY3502970 administered orally.
LY3502970
Administered orally.
Placebo (Part A)
Single dose of placebo administered orally.
Placebo
Administered orally.
LY3502970 (Part B)
Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
LY3502970
Administered orally.
Atorvastatin
Administered orally.
Simvastatin
Administered orally.
Midazolam
Administered orally.
Placebo (Part B)
Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
Placebo
Administered orally.
Atorvastatin
Administered orally.
Simvastatin
Administered orally.
Midazolam
Administered orally.
LY3502970 (Part C)
Single dose of LY3502970 administered orally in each of two study periods.
LY3502970
Administered orally.
LY3502970 (Part D)
Single dose of LY3502970 administered orally.
LY3502970
Administered orally.
Placebo (Part D)
Single dose of placebo administered orally.
Placebo
Administered orally.
LY3502970 Formulation 1 (Part E)
Multiple doses of LY3502970 - formulation 1 administered orally.
LY3502970
Administered orally.
LY3502970 Formulation 2 (Part E)
Multiple doses of LY3502970 - formulation 2 administered orally.
LY3502970
Administered orally.
Interventions
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LY3502970
Administered orally.
Placebo
Administered orally.
Atorvastatin
Administered orally.
Simvastatin
Administered orally.
Midazolam
Administered orally.
Eligibility Criteria
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Inclusion Criteria
* Have safety laboratory results within normal reference ranges
Exclusion Criteria
* Abnormal electrocardiogram (ECG) at screening
* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
18 Years
65 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Covance Dallas
Dallas, Texas, United States
Countries
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References
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Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24.
Other Identifiers
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J2A-MC-GZGA
Identifier Type: OTHER
Identifier Source: secondary_id
17416
Identifier Type: -
Identifier Source: org_study_id