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OpenTrials
Completed

NCT Number: NCT03929744

A Study of LY3502970 in Healthy Participants

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3502970

Drug

Administered orally.

Placebo

Drug

Administered orally.

atorvastatin

Drug

Administered orally.

simvastatin

Drug

Administered orally.

midazolam

Drug

Administered orally.

Primary outcomes

  1. Parts A and B: 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 through Follow-up (up to Day 42)

    An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Secondary outcomes

  1. Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

    Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose

    PK: Cmax of LY3502970

  2. Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970

    Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose

    PK: AUC(0-tlast) of LY3502970

  3. Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970

    Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose

    PK: Tmax of LY3502970

  4. Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)

    PK: Cmax of LY3502970

  5. Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 28

    Time frame: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)

    PK: Cmax of LY3502970

  6. Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)

    PK: AUC(0-tlast) of LY3502970

  7. Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 28

    Time frame: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)

    PK: AUC(0-tlast) of LY3502970

  8. Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)

    PK: Tmax of LY3502970

  9. Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 28

    Time frame: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)

    PK: Tmax of LY3502970

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2019
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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