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A Study of LY3502970 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03929744
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
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 4 parts (A, B, C, and D). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B involves 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
Healthy Drug: LY3502970 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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 : June 12, 2019
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : April 20, 2020

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
Drug: LY3502970
Administered orally

Placebo Comparator: Placebo (Part B)
Multiple doses of placebo administered orally
Drug: Placebo
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




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Predose up to 96 hours postdose ]
    PK: AUC(0-tlast) of LY3502970

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929744


Contacts
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Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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United States, Texas
Covance Recruiting
Dallas, Texas, United States, 75247
Contact    214-647-9399      
Principal Investigator: Thomas Alex King         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03929744     History of Changes
Other Study ID Numbers: 17416
J2A-MC-GZGA ( Other Identifier: Eli Lilly and Company )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No