A Study of LY3374849 in Healthy Participants

NCT03726125 | Completed Phase 1 FDA Drug

• 2 other identifiers: 16939I9R-MC-BSDA
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Glucodynamics: Total Amount of Glucose Infused (Gtot)

  Baseline up to 36 hours post-dose for each study arm

• Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849

  Baseline at predose through 6 days post-dose for each study arm

Study Arms (6)

LY3374849 - SC (Part A)

EXPERIMENTAL

Single subcutaneous (SC) dose of LY3374849

Drug: LY3374849 - SC

Insulin Degludec - SC (Part A)

EXPERIMENTAL

Single SC dose of insulin degludec

Drug: Insulin Degludec - SC

LY3374849 - SC (Part B)

EXPERIMENTAL

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

Drug: LY3374849 - SC

LY3374849 - IV (Part B)

EXPERIMENTAL

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

Drug: LY3374849 - IV

LY3374849 - IV (Part C)

EXPERIMENTAL

Single IV dose of LY3374849 in one of two study periods

Drug: LY3374849 - IV

Insulin Degludec - IV (Part C)

EXPERIMENTAL

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

Drug: Insulin Degludec - IV

Interventions

LY3374849 - SC DRUG

Administered SC

LY3374849 - SC (Part A); LY3374849 - SC (Part B)

Insulin Degludec - SC DRUG

Administered SC

Insulin Degludec - SC (Part A)

LY3374849 - IV DRUG

Administered IV

LY3374849 - IV (Part B); LY3374849 - IV (Part C)

Insulin Degludec - IV DRUG

Administered IV

Insulin Degludec - IV (Part C)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

insulin degludec

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind in Part A. Open label in Parts B and C.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parts B and C are crossover design.

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 31, 2018
• Study Start: November 20, 2018
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: October 17, 2019

Record last verified: 2019-10-15

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)