A Study of LY3502970 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03929744
Collaborator
(none)
133
1
9
16.7
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Part C is a crossover design.Part C is a crossover design.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Healthy Subjects
Actual Study Start Date :
Jun 12, 2019
Actual Primary Completion Date :
Nov 2, 2020
Actual Study Completion Date :
Nov 2, 2020

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

  1. 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

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 [Predose up to 96 hours postdose]

    PK: Cmax of LY3502970

  2. 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

  3. PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 [Predose up to 96 hours postdose]

    PK: Tmax of LY3502970

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

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.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT03929744
Other Study ID Numbers:
  • 17416
  • J2A-MC-GZGA
First Posted:
Apr 29, 2019
Last Update Posted:
Nov 18, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2020