A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo - Capsule; Drug: LY3108743 - Capsule; Drug: LY3108743 - Solution; Drug: Placebo - Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01995656

15197

I7D-FW-SGAA (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes.

The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.

Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant.

The study will have up to 3 parts. Participants may enroll in only one part.

Enrollment: 44 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
• Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m^2), inclusive, at screening
• Have normal blood pressure
• Participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. If on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening
• Participants with diabetes must have a hemoglobin A1c (HbA1c) level between 6 to 11%, inclusive, at screening

Exclusion criteria

• Have previously completed or withdrawn from this study
• Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 6 patient groups, including a placebo group

Placebo - Healthy

Placebo Comparator group

Description:

Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.

Treatment:

Drug: Placebo - Capsule

LY3108743 - Healthy

Experimental group

Description:

Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.

Treatment:

Drug: LY3108743 - Capsule

Placebo - Diabetes

Placebo Comparator group

Description:

Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.

Treatment:

Drug: Placebo - Capsule

LY3108743 - Diabetes

Experimental group

Description:

Part B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.

Treatment:

Drug: LY3108743 - Capsule

Placebo - Solution

Placebo Comparator group

Description:

Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods.

Treatment:

Drug: Placebo - Solution

LY3108743 - Solution

Experimental group

Description:

Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods.

Treatment:

Drug: LY3108743 - Solution