A Study of LY3374849 in Healthy Participants

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3374849 - SC; Drug: Insulin Degludec - SC; Drug: LY3374849 - IV; Drug: Insulin Degludec - IV

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY3374849 - SC (Part A); Single subcutaneous (SC) dose of LY3374849	Drug: LY3374849 - SC; Administered SC
EXPERIMENTAL: Insulin Degludec - SC (Part A); Single SC dose of insulin degludec	Drug: Insulin Degludec - SC; Administered SC
EXPERIMENTAL: LY3374849 - SC (Part B); Single dose of LY3374849 administered SC in up to three of three study periods	Drug: LY3374849 - SC; Administered SC
EXPERIMENTAL: LY3374849 - IV (Part B); Single dose of LY3374849 administered intravenously (IV) in up to one of three study periods	Drug: LY3374849 - IV; Administered IV
EXPERIMENTAL: LY3374849 - IV (Part C); Single IV dose of LY3374849 in one of two study periods	Drug: LY3374849 - IV; Administered IV
EXPERIMENTAL: Insulin Degludec - IV (Part C); Single IV dose of insulin degludec in one of two study periods	Drug: Insulin Degludec - IV; Administered IV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2018
• Primary Completion (ACTUAL): September 27, 2019
• Study Completion (ACTUAL): September 27, 2019

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (ACTUAL): October 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 15, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
• Other Study ID Numbers: 16939; I9R-MC-BSDA (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes