NCT02342314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 13, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

January 14, 2015

Results QC Date

February 17, 2018

Last Update Submit

March 11, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

    Baseline to Study Completion (Up to 84 Days)

Secondary Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (5)

LY3143753 (Part A)

EXPERIMENTAL

Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1

Drug: LY3143753 (Part A)

LY3185643 (Part B)

EXPERIMENTAL

Single SC injection of ascending doses of LY3185643 on Day 1

Drug: LY3185643 (Part B)

Placebo (Part A)

PLACEBO COMPARATOR

Single SC injection of normal saline on Day 1

Drug: Placebo (Part A and Part B)

rGlucagon (Part B)

ACTIVE COMPARATOR

Single SC injection on Day 1

Drug: rGlucagon (Part B)

Placebo (Part B)

PLACEBO COMPARATOR

Single SC injection of normal saline on Day 1

Drug: Placebo (Part A and Part B)

Interventions

LY3143753 (Part A)DRUG

Administered via SC injection

LY3143753 (Part A)
LY3185643 (Part B)DRUG

Administered via SC injection

LY3185643 (Part B)
Placebo (Part A and Part B)DRUG

Administered via SC injection

Placebo (Part A)Placebo (Part B)
rGlucagon (Part B)DRUG

Administered via SC injection

rGlucagon (Part B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, LS2 9LH, United Kingdom

Location

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 13, 2019

Results First Posted

March 13, 2019

Record last verified: 2019-03

Locations

GB(1)