Clinical trial NCT01846702: A Study of LY3084077 in Healthy Participants
Official title: A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3084077 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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* Have previously completed or withdrawn from this study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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Pre-dose, Up to Day 190
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077
timeFrame: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
measure: PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077
timeFrame: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
measure: Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides
timeFrame: Baseline, Up to Day 15
measure: PD: Change From Baseline in Fasting Insulin
timeFrame: Baseline, Up to Day 15
measure: PD: Change From Baseline in Weight
timeFrame: Baseline, Up to Day 15
measure: PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal
timeFrame: Baseline, Day 2
measure: PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal
timeFrame: Baseline, Day 2
measure: PD: Change From Baseline to Day 2 in Fasting Glucagon
timeFrame: Baseline, Up to Day 2
measure: Number of Participants Developing Anti-LY3084077 Antibodies
timeFrame: Pre-dose, Up to Day 190
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: