Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Study of LY3374849 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726125
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3374849 - SC Drug: Insulin Degludec - SC Drug: LY3374849 - IV Drug: Insulin Degludec - IV Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parts B and C are crossover design.
Masking: Double (Participant, Investigator)
Masking Description: Double-blind in Part A. Open label in Parts B and C.
Primary Purpose: Basic Science
Official Title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects
Actual Study Start Date : November 20, 2018
Actual Primary Completion Date : September 27, 2019
Actual Study Completion Date : September 27, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726125


Locations
Layout table for location information
Singapore
Lilly Centre for Clinical Pharmacology
Singapore, Singapore, 138623
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: 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

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03726125    
Other Study ID Numbers: 16939
I9R-MC-BSDA ( Other Identifier: Eli Lilly and Company )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 15, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs