A Study of LY3143753 and LY3185643 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3143753 (Part A); Drug: LY3185643 (Part B); Drug: Placebo (Part A and Part B); Drug: rGlucagon (Part B)

• Registration Number: NCT02342314
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2018-02-17
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Results First Posted: 2019-03-13
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Overtly healthy males or females
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria

• Are investigator site personnel directly affiliated with this study and their immediate families
• Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
• Have participated, within the last 3 months, in a clinical trial
• Have known or ongoing psychiatric disorders
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Show evidence of hepatitis C and/or positive hepatitis C antibody
• Show evidence of hepatitis B and/or positive hepatitis B surface antigen
• History of/current phaeochromocytoma
• History of/current insulinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3143753 (Part A)	LY3143753 (Part A)	Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1
LY3185643 (Part B)	LY3185643 (Part B)	Single SC injection of ascending doses of LY3185643 on Day 1
Placebo (Part A)	Placebo (Part A and Part B)	Single SC injection of normal saline on Day 1
rGlucagon (Part B)	rGlucagon (Part B)	Single SC injection on Day 1
Placebo (Part B)	Placebo (Part A and Part B)	Single SC injection of normal saline on Day 1

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline to Study Completion (Up to 84 Days)	A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Cmax of Part B	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: AUC(0-∞) of Part B	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Time to Maximum Drug Concentration (Tmax) of Part A	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Tmax of Part B	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD Absolute Maximum Blood Glucose of Part B	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Maximum Glucose Increase (Gmax) of Part A	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Gmax of Part B	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Time to Maximum Blood Glucose (Gtmax) of Part A	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Gtmax of Part B	Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A	Baseline, 8 hours after drug administration
QTcF Change From Baseline of Part B	Baseline, 8 hours after drug administration

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇬🇧 Leeds, United Kingdom