A Study of LY3463251 in Healthy Participants

• ClinicalTrials.gov Identifier: NCT03764774
• Recruitment Status: Terminated
• First Posted: December 5, 2018
• Last Update Posted: December 21, 2020
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: December 4, 2018
• First Posted Date: December 5, 2018
• Last Update Posted Date: December 21, 2020
• Actual Study Start Date: December 6, 2018
• Actual Primary Completion Date: December 7, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2019)

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

Original Primary Outcome Measures (submitted: December 4, 2018)

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 (up to Day 64) ]

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Current Secondary Outcome Measures (submitted: September 26, 2019)

• 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
• 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
• Pharmacodynamics (PD): AUC of glucose [ Time Frame: Baseline to Day 85 (Part B) ]
  PD: AUC of glucose
• Change from Baseline in Body Weight [ Time Frame: Baseline, Day 85 (Part B) ]
  Change from Baseline in Body Weight

Original Secondary Outcome Measures (submitted: December 4, 2018)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 [ Time Frame: Baseline to Day 29 (Part A); Baseline to Day 57 (Part B) ]
  PK: Cmax of LY3463251
• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3463251 [ Time Frame: Baseline to Day 29 (Part A); Baseline to Day 57 (Part B) ]
  PK: AUC of LY3463251
• Pharmacodynamics (PD): AUC of glucose [ Time Frame: Baseline to Day 57 (Part B) ]
  PD: AUC of glucose
• Change from Baseline in Body Weight [ Time Frame: Baseline, Day 57 (Part B) ]
  Change from Baseline in Body Weight

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of LY3463251 in Healthy Participants
• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• Drug: LY3463251
  Administered SC
• Drug: Placebo
  Administered SC

Study Arms

• Experimental: LY3463251 Single dose
  Single dose of LY3463251 administered subcutaneously (SC)
  Intervention: Drug: LY3463251
• Placebo Comparator: Placebo Single dose
  Single dose of placebo administered SC
  Intervention: Drug: Placebo
• Experimental: LY3463251 Multiple Dose
  Multiple doses of LY3463251 administered SC
  Intervention: Drug: LY3463251
• Placebo Comparator: Placebo Multiple Dose
  Multiple doses of placebo administered SC
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 18, 2020): 118
• Original Estimated Enrollment (submitted: December 4, 2018): 143
• Actual Study Completion Date: December 7, 2020
• Actual Primary Completion Date: December 7, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03764774
• Other Study ID Numbers: 17110; J1D-MC-GZAA ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Eli Lilly and Company
• Verification Date: December 2020