A Study of LY3502970 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3502970; Drug: Atorvastatin; Drug: Simvastatin; Drug: Midazolam

• Registration Number: NCT03929744
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purposes of this study are to determine:

* 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

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Study Start: 2019-06-12
• Status Verified: 2020-11
• Primary Completion: 2020-11-02
• Study Completion: 2020-11-02
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• Healthy male or females, as determined by medical history
• Have safety laboratory results within normal reference ranges

Exclusion Criteria

• Have known allergies to LY3502970, glucagon-like peptide-1 (GLP-1) analogs, related compounds
• Abnormal electrocardiogram (ECG) at screening
• Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo (Part A)	Placebo	Single dose of placebo administered orally.
Placebo (Part D)	Placebo	Single dose of placebo administered orally.
Placebo (Part B)	Placebo	Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
LY3502970 (Part C)	LY3502970	Single dose of LY3502970 administered orally in each of two study periods.
LY3502970 (Part B)	LY3502970	Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
LY3502970 (Part D)	LY3502970	Single dose of LY3502970 administered orally.
LY3502970 (Part A)	LY3502970	Single dose of LY3502970 administered orally.
LY3502970 Formulation 1 (Part E)	LY3502970	Multiple doses of LY3502970 - formulation 1 administered orally.
LY3502970 Formulation 2 (Part E)	LY3502970	Multiple doses of LY3502970 - formulation 2 administered orally.
LY3502970 (Part B)	Atorvastatin	Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
LY3502970 (Part B)	Simvastatin	Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
LY3502970 (Part B)	Midazolam	Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
Placebo (Part B)	Atorvastatin	Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
Placebo (Part B)	Simvastatin	Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
Placebo (Part B)	Midazolam	Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Covance Dallas; 🇺🇸 Dallas, Texas, United States