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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

A Study of LY3502970 in Healthy Participants

Clinicaltrials.gov identifier NCT03929744

Recruitment Status Completed

First Posted April 29, 2019

Last update posted November 18, 2020

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:Healthy
  • Intervention/Treatment: Drug: LY3502970
    Drug: Placebo
    Drug: Atorvastatin
    Drug: Simvastatin
    Drug: Midazolam
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 133 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 2019
  • Actual Primary Completion Date: November 2020
  • Actual Study Completion Date: November 2020
Arms and interventions
Arm Intervention/treatment
Experimental: LY3502970 (Part A)
Single dose of LY3502970 administered orally.
Drug: LY3502970
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.
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.
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.
Placebo Comparator: Placebo (Part A)
Single dose of placebo administered orally.
Drug: Placebo
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.
Placebo Comparator: Placebo (Part D)
Single dose of placebo administered orally.
Drug: Placebo
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 [ 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
Eligibility Criteria
  • Ages Eligible for Study: 18 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.

Contacts and Locations
Contacts
Locations

United States, Texas
Covance Dallas
Dallas

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

More Information
  • Responsible Party: Eli Lilly and Company
  • ClinicalTrials.gov Identifier: NCT03929744 History of Changes
  • Other Study ID Numbers: 17416, J2A-MC-GZGA
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: November 18, 2020
  • Last Verified: November 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No