A Study of LY3084077 in Healthy Participants

NCT01846702 | Completed Phase 1 Results

• 2 other identifiers: 14530I6P-MC-FMRA
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

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

  An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

  Pre-dose, Up to Day 190

Secondary Outcomes (9)

• Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077

  Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose

• PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077

  Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose

• Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides

  Baseline, Up to Day 15

• PD: Change From Baseline in Fasting Insulin

  Baseline, Up to Day 15

• PD: Change From Baseline in Weight

  Baseline, Up to Day 15

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

LY3084077

EXPERIMENTAL

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

Drug: LY3084077

Interventions

Placebo DRUG

Given as a SC injection.

Placebo

LY3084077 DRUG

Given as a SC injection.

LY3084077

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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, 117597, Singapore

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: Yes
• Restrictive Agreement: No

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: May 1, 2013
• First Posted: May 3, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 30, 2018
• Results First Posted: July 30, 2018

Record last verified: 2017-10

Locations

SG (1)