A Study of LY3463251 in Healthy Participants

Lilly

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3463251

Study type: Interventional

Funder types: Industry

Identifiers

NCT03764774

J1D-MC-GZAA (Other Identifier)

17110

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.

This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.

Enrollment: 118 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females

Exclusion criteria

• Diagnosed with Type 1 or Type 2 diabetes
• Women who are of childbearing potential or who are breastfeeding
• Donated blood of more than 500 millilitres (mL) within the previous 3 months of study screening
• Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain from the use of tobacco during the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 14 patient groups, including a placebo group

0.01 Milligram (mg) LY3463251 Part A Cohort 1

Experimental group

Description:

Single dose of 0.01 mg LY3463251 administered subcutaneously (SC) on Day 1.

Treatment:

Drug: LY3463251

0.03 mg LY3463251 Part A Cohort 2

Experimental group

Description:

Single dose of 0.03 mg LY3463251 administered SC on Day 1.

Treatment:

Drug: LY3463251

0.1 mg LY3463251 Part A Cohort 3

Experimental group

Description:

Single dose of 0.1 mg LY3463251 administered SC on Day 1.

Treatment:

Drug: LY3463251

0.3 mg LY3463251 Part A Cohort 4

Experimental group

Description:

Single dose of 0.3 mg LY3463251 administered SC on Day 1.

Treatment:

Drug: LY3463251

1 mg LY3463251 Part A Cohort 5

Experimental group

Description:

Single dose of 1 mg LY3463251 administered SC on Day 1.

Treatment:

Drug: LY3463251

3 mg LY3463251 Part A Cohort 6

Experimental group

Description:

Single dose of 3 mg LY3463251 administered SC on Day 1.

Treatment:

Drug: LY3463251

10 mg LY3463251 Part A Cohort 7

Experimental group

Description:

Single dose of 10 mg LY3463251 administered SC on Day 1.

Treatment:

Drug: LY3463251

24 mg LY3463251 Part A Cohort 8

Experimental group

Description:

Single dose of 24 mg LY3463251 administered SC on Day 1.

Treatment:

Drug: LY3463251

Placebo Single Dose

Placebo Comparator group

Description:

Single dose of placebo administered SC.

Treatment:

Drug: Placebo

1 mg LY3463251 Part B Cohort 1

Experimental group

Description:

1 mg LY3463251 administered SC, once weekly (QW) for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.

Treatment:

Drug: LY3463251

3 mg LY3465231 Part B Cohort 2

Experimental group

Description:

3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.

Treatment:

Drug: LY3463251

3/6/9 mg LY3463251 Part B Cohort 3

Experimental group

Description:

3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.

Treatment:

Drug: LY3463251

3/9/15/24 mg LY3463251 Part B Cohort

Experimental group

Description:

3 mg LY3463251 administered SC, QW on Days 1 and 8. 9 mg LY3463251 administered SC, QW on Days 15 and 22. 15 mg LY3463251 administered SC, QW on Days 29 and 36. 24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.

Treatment:

Drug: LY3463251

Placebo Multiple Dose

Placebo Comparator group

Description:

Placebo administered SC, QW for 12 weeks.

Treatment:

Drug: Placebo