A Study of LY3084077 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3084077 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846702
• Other study ID #: 14530
• Secondary ID: I6P-MC-FMRA
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: October 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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• Have previously completed or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Placebo
Given as a SC injection.
• LY3084077
Given as a SC injection.

Locations

Country	Name	City	State
Singapore	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-8]) 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
Secondary	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
Secondary	Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides	Percent change=(measure at time t-measure at baseline)/measure at baseline*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.	Baseline, Up to Day 15
Secondary	PD: Change From Baseline in Fasting Insulin	LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.	Baseline, Up to Day 15
Secondary	PD: Change From Baseline in Weight		Baseline, Up to Day 15
Secondary	PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal	LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.	Baseline, Day 2
Secondary	PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal	LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.	Baseline, Day 2
Secondary	PD: Change From Baseline to Day 2 in Fasting Glucagon	LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.	Baseline, Up to Day 2
Secondary	Number of Participants Developing Anti-LY3084077 Antibodies	The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.	Pre-dose, Up to Day 190