A Study of LY3502970 in Healthy Participants
Study Details
Study Description
Brief Summary
The main purposes of this study are to determine:
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The safety of LY3502970 and any side effects that might be associated with it.
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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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LY3502970 (Part A) Single dose of LY3502970 administered orally. |
Drug: LY3502970
Administered orally.
|
Placebo Comparator: Placebo (Part A) Single dose of placebo administered orally. |
Drug: Placebo
Administered orally.
|
Experimental: LY3502970 (Part B) Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally. |
Drug: LY3502970
Administered orally.
Drug: Atorvastatin
Administered orally.
Drug: Simvastatin
Administered orally.
Drug: Midazolam
Administered orally.
|
Placebo Comparator: Placebo (Part B) Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally. |
Drug: Placebo
Administered orally.
Drug: Atorvastatin
Administered orally.
Drug: Simvastatin
Administered orally.
Drug: Midazolam
Administered orally.
|
Experimental: LY3502970 (Part C) Single dose of LY3502970 administered orally in each of two study periods. |
Drug: LY3502970
Administered orally.
|
Experimental: LY3502970 (Part D) Single dose of LY3502970 administered orally. |
Drug: LY3502970
Administered orally.
|
Placebo Comparator: Placebo (Part D) Single dose of placebo administered orally. |
Drug: Placebo
Administered orally.
|
Experimental: LY3502970 Formulation 1 (Part E) Multiple doses of LY3502970 - formulation 1 administered orally. |
Drug: LY3502970
Administered orally.
|
Experimental: LY3502970 Formulation 2 (Part E) Multiple doses of LY3502970 - formulation 2 administered orally. |
Drug: LY3502970
Administered orally.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [Baseline up to Day 42]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 [Predose up to 96 hours postdose]
PK: Cmax of LY3502970
- PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 [Predose up to 96 hours postdose]
PK: AUC(0-tlast) of LY3502970
- PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 [Predose up to 96 hours postdose]
PK: Tmax of LY3502970
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male or females, as determined by medical history
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Have safety laboratory results within normal reference ranges
Exclusion Criteria:
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Have known allergies to LY3502970, glucagon-like peptide-1 (GLP-1) analogs, related compounds
-
Abnormal electrocardiogram (ECG) at screening
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Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Covance Dallas | Dallas | Texas | United States | 75247 |
Sponsors and Collaborators
- Eli Lilly and Company
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17416
- J2A-MC-GZGA