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A Study of LY3463251 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: NCT03764774
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : December 5, 2018
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.

This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.


Condition or disease Intervention/treatment Phase
Healthy Drug: LY3463251 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 20, 2020

Arm Intervention/treatment
Experimental: LY3463251 Single dose
Single dose of LY3463251 administered subcutaneously (SC)
Drug: LY3463251
Administered SC

Placebo Comparator: Placebo Single dose
Single dose of placebo administered SC
Drug: Placebo
Administered SC

Experimental: LY3463251 Multiple Dose
Multiple doses of LY3463251 administered SC
Drug: LY3463251
Administered SC

Placebo Comparator: Placebo Multiple Dose
Multiple doses of placebo administered SC
Drug: Placebo
Administered SC




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 through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123) ]
    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. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 [ Time Frame: Baseline to Day 29 (Part A); Baseline to Day 107 (Part B) ]
    PK: Cmax of LY3463251

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3463251 [ Time Frame: Baseline to Day 29 (Part A); Baseline to Day 107(Part B) ]
    PK: AUC of LY3463251

  3. Pharmacodynamics (PD): AUC of glucose [ Time Frame: Baseline to Day 85 (Part B) ]
    PD: AUC of glucose

  4. Change from Baseline in Body Weight [ Time Frame: Baseline, Day 85 (Part B) ]
    Change from Baseline in Body Weight



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females

Exclusion Criteria:

  • Diagnosed with Type 1 or Type 2 diabetes
  • Women who are of childbearing potential or who are breastfeeding
  • Donated blood of more than 500 millilitres (mL) within the previous 3 months of study screening
  • Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain from the use of tobacco during the study

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): NCT03764774


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03764774    
Other Study ID Numbers: 17110
J1D-MC-GZAA ( Other Identifier: Eli Lilly and Company )
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No