A Study of LY3502970 in Healthy Participants

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Midazolam; Drug: Placebo; Drug: LY3502970; Drug: Atorvastatin; Drug: Simvastatin

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / 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: Midazolam; Administered orally.; Drug: LY3502970; Administered orally.; Drug: Atorvastatin; Administered orally.; Drug: Simvastatin; 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: Midazolam; Administered orally.; Drug: Placebo; Administered orally.; Drug: Atorvastatin; Administered orally.; Drug: Simvastatin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 96 hours postdose
PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970	PK: AUC(0-tlast) of LY3502970	Predose up to 96 hours postdose
PK: Time of Maximum Observed Concentration (Tmax) of LY3502970	PK: Tmax of LY3502970	Predose up to 96 hours postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): November 2, 2020

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Atorvastatin; Midazolam; Simvastatin
• Other Study ID Numbers: 17416; J2A-MC-GZGA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No