A Study of LY3502970 in Healthy Participants

Status

Completed

Phase

Phase 1

Enrollment

133 participants (actual)

Sponsor

Eli Lilly and Company · Industry

Design

Randomized · Double masking

Countries

1 country

United States

Start

12 Jun 2019

Primary completion

2 Nov 2020

Completion

2 Nov 2020

First posted

29 Apr 2019

Last update posted

10 Jul 2026

Conditions

Healthy

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.

• Experimental

  Part A 0.3 mg LY3502970

  Participants received a single oral dose of 0.3 milligram (mg) LY3502970.

• Experimental

  Part A 1 mg LY3502970

  Participants received a single oral dose of 1 mg LY3502970.

• Experimental

  Part A 3 mg LY3502970

  Participants received a single oral dose of 3 mg LY3502970.

• Experimental

  Part A 6 mg LY3502970

  Participants received a single oral dose of 6 mg LY3502970.

• Placebo comparator

  Part A Placebo

  Participants received a single oral dose of Placebo.

• Placebo comparator

  Part B Placebo

  Participants received oral doses of placebo once daily for 4 weeks.

• Experimental

  Part B: 2 mg LY3502970 (Cohort G)

  Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.

• Experimental

  Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)

  Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.

• Experimental

  Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)

  Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.

• Experimental

  Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)

  Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.

• Experimental

  Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)

  Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.

• Experimental

  Part C: 3 mg LY3502970 (Fasted/Fed)

  Part C of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.

• Experimental

  Part C: 3 mg LY3502970 (Fed/Fasted)

  Part C of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.

• Active comparator

  Part D: 3 mg LY3502970 Prototype Formulation

  Part D of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.

• Placebo comparator

  Part D: Placebo Prototype Formulation

  Part D of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of placebo in a controlled-release prototype formulation.

• Experimental

  Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)

  Part E of the study is exploratory, conducted to study exploratory objectives. Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.

• Experimental

  Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)

  Part E of the study is exploratory, conducted to study exploratory objectives. Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.

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)

   Registry description

   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.