A Study of LY3502970 in Healthy Participants

NCT ID: NCT03929744

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2020-11-02

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Part C is a crossover design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3502970 (Part A)

Single dose of LY3502970 administered orally.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

Placebo (Part A)

Single dose of placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

LY3502970 (Part B)

Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

Atorvastatin

Intervention Type DRUG

Administered orally.

Simvastatin

Intervention Type DRUG

Administered orally.

Midazolam

Intervention Type DRUG

Administered orally.

Placebo (Part B)

Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Atorvastatin

Intervention Type DRUG

Administered orally.

Simvastatin

Intervention Type DRUG

Administered orally.

Midazolam

Intervention Type DRUG

Administered orally.

LY3502970 (Part C)

Single dose of LY3502970 administered orally in each of two study periods.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

LY3502970 (Part D)

Single dose of LY3502970 administered orally.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

Placebo (Part D)

Single dose of placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

LY3502970 Formulation 1 (Part E)

Multiple doses of LY3502970 - formulation 1 administered orally.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

LY3502970 Formulation 2 (Part E)

Multiple doses of LY3502970 - formulation 2 administered orally.

Group Type EXPERIMENTAL

LY3502970

Intervention Type DRUG

Administered orally.

Interventions

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LY3502970

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Atorvastatin

Administered orally.

Intervention Type DRUG

Simvastatin

Administered orally.

Intervention Type DRUG

Midazolam

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Covance Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24.

Reference Type DERIVED
PMID: 38402332 (View on PubMed)

Other Identifiers

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J2A-MC-GZGA

Identifier Type: OTHER

Identifier Source: secondary_id

17416

Identifier Type: -

Identifier Source: org_study_id