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A First-in-Human Study of LY3009385 in Healthy Participants

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
LY3009385
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Are a healthy male or a female who cannot become pregnant
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2) at screening
  • Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study
  • Have veins suitable for easy blood collection
  • Are reliable and willing to be available for the whole study and be willing to follow study procedures
  • Have given consent to participate in this study

Exclusion Criteria:

  • Are currently participating in or were in another new drug or device or in any medical research study in the last 30 days
  • Currently have or used to have allergies or other health problems or laboratory test results that in the opinion of the doctor, could make it unsafe for the participant to participate, or interfere with understanding the results of this study
  • Have received live vaccine(s) within 1 month of screening, or intend to during the study
  • Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
  • Have a weakened immune system
  • Have previously completed or withdrawn from this study
  • Have illnesses or conditions that may increase risk when taking the study medication or interfere with the interpretation of data in this study
  • Have electrocardiogram (ECG) readings that are not suitable for the study
  • Are using or intend to use over-the-counter medications or prescription medications within 7 and 14 days (respectively) from the start of the first study dosing until end of the study
  • Have a history of drug or alcohol abuse
  • Are infected with hepatitis B
  • Are infected with human immunodeficiency virus (HIV)
  • Have donated 450 milliliters (mL) or more of blood in the last 3 months or made any blood donation within the last month
  • Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are unwilling to abstain from alcohol 24 hours before dosing until the completion of each inpatient study period
  • Smoke more than 10 cigarettes per day or are unable or unwilling to refrain from smoking while at the clinic
  • Are unwilling or unable to follow dietary requirements/restrictions for the study and only consume only the meals provided during inpatient stays at the clinical research unit
  • Are deemed unsuitable to participate by the study doctor for any other reasons

Sites / Locations

  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

0.3 mg LY3009385

1 mg LY3009385

3 mg LY3009385

9 mg LY3009385

22 mg LY3009385

54 mg LY3009385

Placebo

Arm Description

LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1

LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1

LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1

LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1

LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1

LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1

Placebo: saline, subcutaneous (SC) injection, single dose on Day 1

Outcomes

Primary Outcome Measures

Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary Outcome Measures

Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385
LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.
Pharmacokinetics: Maximum Concentration (Cmax)
The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.
Change in Level of Blood Glucose Before and After a Standard Meal
The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.
Change in Level of C-peptide Before and After a Standard Meal
The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.
Change in Level of Glucagon Before and After a Standard Meal
The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.
Number of Participants Forming Antibody to LY3009385
The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.

Full Information

First Posted
November 18, 2011
Last Updated
October 2, 2014
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01477567
Brief Title
A First-in-Human Study of LY3009385 in Healthy Participants
Official Title
A Single Ascending Dose (SAD) Study of LY3009385 in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.
Detailed Description
This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo. Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data. The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.3 mg LY3009385
Arm Type
Experimental
Arm Description
LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Arm Title
1 mg LY3009385
Arm Type
Experimental
Arm Description
LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Arm Title
3 mg LY3009385
Arm Type
Experimental
Arm Description
LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Arm Title
9 mg LY3009385
Arm Type
Experimental
Arm Description
LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Arm Title
22 mg LY3009385
Arm Type
Experimental
Arm Description
LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Arm Title
54 mg LY3009385
Arm Type
Experimental
Arm Description
LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
Intervention Type
Drug
Intervention Name(s)
LY3009385
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
Description
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame
Baseline through Day 28
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385
Description
LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.
Time Frame
Predose through Day 28
Title
Pharmacokinetics: Maximum Concentration (Cmax)
Description
The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.
Time Frame
Predose through Day 28
Title
Change in Level of Blood Glucose Before and After a Standard Meal
Description
The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.
Time Frame
Baseline, Day 5, and Day 14
Title
Change in Level of C-peptide Before and After a Standard Meal
Description
The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.
Time Frame
Baseline, Day 5, and Day 14
Title
Change in Level of Glucagon Before and After a Standard Meal
Description
The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.
Time Frame
Baseline, Day 14
Title
Number of Participants Forming Antibody to LY3009385
Description
The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.
Time Frame
Baseline through Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are a healthy male or a female who cannot become pregnant Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2) at screening Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study Have veins suitable for easy blood collection Are reliable and willing to be available for the whole study and be willing to follow study procedures Have given consent to participate in this study Exclusion Criteria: Are currently participating in or were in another new drug or device or in any medical research study in the last 30 days Currently have or used to have allergies or other health problems or laboratory test results that in the opinion of the doctor, could make it unsafe for the participant to participate, or interfere with understanding the results of this study Have received live vaccine(s) within 1 month of screening, or intend to during the study Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing Have a weakened immune system Have previously completed or withdrawn from this study Have illnesses or conditions that may increase risk when taking the study medication or interfere with the interpretation of data in this study Have electrocardiogram (ECG) readings that are not suitable for the study Are using or intend to use over-the-counter medications or prescription medications within 7 and 14 days (respectively) from the start of the first study dosing until end of the study Have a history of drug or alcohol abuse Are infected with hepatitis B Are infected with human immunodeficiency virus (HIV) Have donated 450 milliliters (mL) or more of blood in the last 3 months or made any blood donation within the last month Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are unwilling to abstain from alcohol 24 hours before dosing until the completion of each inpatient study period Smoke more than 10 cigarettes per day or are unable or unwilling to refrain from smoking while at the clinic Are unwilling or unable to follow dietary requirements/restrictions for the study and only consume only the meals provided during inpatient stays at the clinical research unit Are deemed unsuitable to participate by the study doctor for any other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Singapore
Country
Singapore

12. IPD Sharing Statement

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A First-in-Human Study of LY3009385 in Healthy Participants

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