Clinical trial NCT03726125: A Study of LY3374849 in Healthy Participants
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 89
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parts B and C are crossover design.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to study completion (estimated at 11 weeks)
Secondary outcomes:
measure: Glucodynamics: Total Amount of Glucose Infused (Gtot)
timeFrame: Baseline up to 36 hours post-dose for each study arm
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849
timeFrame: Baseline at predose through 6 days post-dose for each study arm
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: