A Study of LY3374849 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3374849 - IV; Drug: Insulin Degludec - SC; Drug: Insulin Degludec - IV; Drug: LY3374849 - SC

• Registration Number: NCT03726125
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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).

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Study Start: 2018-11-20
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Status Verified: 2019-10-15
• Last Update Submitted: 2019-10-16
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3374849 - IV (Part C)	LY3374849 - IV	Single IV dose of LY3374849 in one of two study periods
Insulin Degludec - SC (Part A)	Insulin Degludec - SC	Single SC dose of insulin degludec
LY3374849 - IV (Part B)	LY3374849 - IV	Single dose of LY3374849 administered intravenously (IV) in up to one of three study periods
Insulin Degludec - IV (Part C)	Insulin Degludec - IV	Single IV dose of insulin degludec in one of two study periods
LY3374849 - SC (Part B)	LY3374849 - SC	Single dose of LY3374849 administered SC in up to three of three study periods
LY3374849 - SC (Part A)	LY3374849 - SC	Single subcutaneous (SC) dose of LY3374849

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to study completion (estimated at 11 weeks)	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849	Baseline at predose through 6 days post-dose for each study arm	Pharmacokinetics: AUC of LY3374849
Glucodynamics: Total Amount of Glucose Infused (Gtot)	Baseline up to 36 hours post-dose for each study arm	Glucodynamics: Gtot

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore