A Study of LY3502970 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Atorvastatin; Drug: Simvastatin; Drug: Midazolam; Drug: Placebo; Drug: LY3502970

Study type: Interventional

Funder types: Industry

Identifiers

NCT03929744

17416

J2A-MC-GZGA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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133 participants in 9 patient groups, including a placebo group

LY3502970 (Part A)

Experimental group

Description:

Single dose of LY3502970 administered orally.

Treatment:

Drug: LY3502970

Placebo (Part A)

Placebo Comparator group

Description:

Single dose of placebo administered orally.

Treatment:

Drug: Placebo

LY3502970 (Part B)

Experimental group

Description:

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

Treatment:

Drug: Simvastatin

Drug: Midazolam

Drug: LY3502970

Drug: Atorvastatin

Placebo (Part B)

Placebo Comparator group

Description:

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

Treatment:

Drug: Simvastatin

Drug: Placebo

Drug: Midazolam

Drug: Atorvastatin

LY3502970 (Part C)

Experimental group

Description:

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

Treatment:

Drug: LY3502970

LY3502970 (Part D)

Experimental group

Description:

Single dose of LY3502970 administered orally.

Treatment:

Drug: LY3502970

Placebo (Part D)

Placebo Comparator group

Description:

Single dose of placebo administered orally.

Treatment:

Drug: Placebo

LY3502970 Formulation 1 (Part E)

Experimental group

Description:

Multiple doses of LY3502970 - formulation 1 administered orally.

Treatment:

Drug: LY3502970

LY3502970 Formulation 2 (Part E)

Experimental group

Description:

Multiple doses of LY3502970 - formulation 2 administered orally.

Treatment:

Drug: LY3502970