A Study of LY3143753 and LY3185643 in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-09-30

Brief Summary

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The study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3143753 (Part A)

Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1

Group Type EXPERIMENTAL

LY3143753 (Part A)

Intervention Type DRUG

Administered via SC injection

LY3185643 (Part B)

Single SC injection of ascending doses of LY3185643 on Day 1

Group Type EXPERIMENTAL

LY3185643 (Part B)

Intervention Type DRUG

Administered via SC injection

Placebo (Part A)

Single SC injection of normal saline on Day 1

Group Type PLACEBO_COMPARATOR

Placebo (Part A and Part B)

Intervention Type DRUG

Administered via SC injection

rGlucagon (Part B)

Single SC injection on Day 1

Group Type ACTIVE_COMPARATOR

rGlucagon (Part B)

Intervention Type DRUG

Administered via SC injection

Placebo (Part B)

Single SC injection of normal saline on Day 1

Group Type PLACEBO_COMPARATOR

Placebo (Part A and Part B)

Intervention Type DRUG

Administered via SC injection

Interventions

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LY3143753 (Part A)

Administered via SC injection

Intervention Type DRUG

LY3185643 (Part B)

Administered via SC injection

Intervention Type DRUG

Placebo (Part A and Part B)

Administered via SC injection

Intervention Type DRUG

rGlucagon (Part B)

Administered via SC injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy males or females
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria

* Are investigator site personnel directly affiliated with this study and their immediate families
* Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
* Have participated, within the last 3 months, in a clinical trial
* Have known or ongoing psychiatric disorders
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
* History of/current phaeochromocytoma
* History of/current insulinoma

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes