A Study of LY3374849 in Healthy Participants

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

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2019-09-27

Brief Summary

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The aim of this trial is to evaluate the safety and tolerability of the study drug known as LY3374849, when given as an injection to healthy participants.

The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and how it affects the levels of blood sugar in comparison to insulin degludec, after a single dose is given by injection under the skin and directly into a vein.

Participation in this study includes screening, which is required within 28 days before start of study and a follow up at least 28 days after receiving the last dose of study drug.

This study has 3 parts:

* Participants in Part A will complete 1 study period (approximately 1 week).
* Participants in Part B will complete 3 study periods (approximately 3 weeks).
* Participants in Part C will complete 2 study periods (approximately 2 weeks).

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Detailed Description

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Parts B and C added per protocol amendment, approved in April 2019.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parts B and C are crossover design.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind in Part A. Open label in Parts B and C.

Study Groups

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LY3374849 - SC (Part A)

Single subcutaneous (SC) dose of LY3374849

Group Type EXPERIMENTAL

LY3374849 - SC

Intervention Type DRUG

Administered SC

Insulin Degludec - SC (Part A)

Single SC dose of insulin degludec

Group Type EXPERIMENTAL

Insulin Degludec - SC

Intervention Type DRUG

Administered SC

LY3374849 - SC (Part B)

Single dose of LY3374849 administered SC in up to three of three study periods

Group Type EXPERIMENTAL

LY3374849 - SC

Intervention Type DRUG

Administered SC

LY3374849 - IV (Part B)

Single dose of LY3374849 administered intravenously (IV) in up to one of three study periods

Group Type EXPERIMENTAL

LY3374849 - IV

Intervention Type DRUG

Administered IV

LY3374849 - IV (Part C)

Single IV dose of LY3374849 in one of two study periods

Group Type EXPERIMENTAL

LY3374849 - IV

Intervention Type DRUG

Administered IV

Insulin Degludec - IV (Part C)

Single IV dose of insulin degludec in one of two study periods

Group Type EXPERIMENTAL

Insulin Degludec - IV

Intervention Type DRUG

Administered IV

Interventions

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LY3374849 - SC

Administered SC

Intervention Type DRUG

Insulin Degludec - SC

Administered SC

Intervention Type DRUG

LY3374849 - IV

Administered IV

Intervention Type DRUG

Insulin Degludec - IV

Administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or a female who cannot become pregnant
* Have a body mass index (BMI) of at least 18 kilogram per square meter (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Had donated or had blood loss of more than 450 milliliters (mL) within the last 3 months
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
* Smoke more than 10 cigarettes per day
* Are infected with hepatitis B or human immunodeficiency virus (HIV)
* Have a history of allergies or reactions to more than one drug, or significant severe drug allergy
* Are taking illegal drugs

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes