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NCT Number: NCT03726125

A Study of LY3374849 in Healthy Participants

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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Key information

Conditions

Healthy

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3374849 - SC

Drug

Administered SC

Insulin Degludec - SC

Drug

Administered SC

LY3374849 - IV

Drug

Administered IV

Insulin Degludec - IV

Drug

Administered IV

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

    Time frame: 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 outcomes

  1. Glucodynamics: Total Amount of Glucose Infused (Gtot)

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

    Glucodynamics: Gtot

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

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

    Pharmacokinetics: AUC of LY3374849

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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