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

NCT01477567 | Completed Phase 1 Results

• 2 other identifiers: 14195I5O-FW-GTCA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline through Day 28

Secondary Outcomes (6)

• Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385

  Predose through Day 28

• Pharmacokinetics: Maximum Concentration (Cmax)

  Predose through Day 28

• Change in Level of Blood Glucose Before and After a Standard Meal

  Baseline, Day 5, and Day 14

• Change in Level of C-peptide Before and After a Standard Meal

  Baseline, Day 5, and Day 14

• Change in Level of Glucagon Before and After a Standard Meal

  Baseline, Day 14

Study Arms (7)

0.3 mg LY3009385

EXPERIMENTAL

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

Drug: LY3009385

1 mg LY3009385

EXPERIMENTAL

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

Drug: LY3009385

3 mg LY3009385

EXPERIMENTAL

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

Drug: LY3009385

9 mg LY3009385

EXPERIMENTAL

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

Drug: LY3009385

22 mg LY3009385

EXPERIMENTAL

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

Drug: LY3009385

54 mg LY3009385

EXPERIMENTAL

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

Drug: LY3009385

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3009385 DRUG

0.3 mg LY3009385; 1 mg LY3009385; 22 mg LY3009385; 3 mg LY3009385; 54 mg LY3009385; 9 mg LY3009385

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

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.

Singapore, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: 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: November 18, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 6, 2014
• Results First Posted: October 6, 2014

Record last verified: 2014-10

Locations

SG (1)