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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03929744
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : April 29, 2019
Last Update Posted : May 1, 2020
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 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
Healthy Drug: LY3502970 Drug: Placebo Drug: Atorvastatin Drug: Simvastatin Drug: Midazolam Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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 : October 5, 2020
Estimated Study Completion Date : October 5, 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. 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.




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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
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United States, Texas
Covance
Dallas, Texas, United States, 75247
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    
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: May 1, 2020
Last Verified: April 2020
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
Additional relevant MeSH terms:
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Midazolam
Atorvastatin
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents