A Study of LY3084077 in Healthy Participants

NCT ID: NCT01846702

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-12-31

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3084077 in healthy participants. The study will also investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study is expected to last approximately 8 weeks for each participant.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Single dose of placebo matching LY3084077 administered subcutaneously (SC).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Given as a SC injection.

LY3084077

Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC.

Group Type: EXPERIMENTAL

LY3084077

Intervention Type: DRUG

Given as a SC injection.

Interventions

Placebo

Given as a SC injection.

Intervention Type: DRUG

LY3084077

Given as a SC injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have normal blood pressure
• Must be a healthy male or female who cannot become pregnant
• Have a body mass index (BMI) of 18.5 to 40.0 kg/m^2, inclusive, at screening

Exclusion Criteria

• Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like peptide-1 (GLP1), GLP1-analogues or other related compounds
• Have previous exposure to FGF21 analogues or GLP1 analogues
• Have received live vaccine(s) within 1 month of screening, or intend to during the study
• Have previously completed or withdrawn from this study
• Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that in the opinion of the doctor, could make it unsafe to participate, or interfere with understanding the results of 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 problems with the immune system, due to a disease or treatment
• Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia syndrome type 2
• Have a history of pancreatitis

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

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.

Singapore, , Singapore

Countries

Singapore

Other Identifiers

I6P-MC-FMRA

Identifier Type: OTHER

Identifier Source: secondary_id

14530

Identifier Type: -

Identifier Source: org_study_id