A Study of LY3084077 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: LY3084077

• Registration Number: NCT01846702
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2017-10
• Results First Submitted: 2017-10-21
• Results First Submitted QC: 2017-10-21
• Last Update Submitted: 2017-10-21
• Results First Posted: 2018-07-30
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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• Have previously completed or withdrawn from this study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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single dose of placebo matching LY3084077 administered subcutaneously (SC).
LY3084077	LY3084077	Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Pre-dose, Up to Day 190	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.

Secondary Outcome Measures

Name	Time	Method
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
PD: Change From Baseline in Fasting Insulin	Baseline, Up to Day 15	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.
Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides	Baseline, Up to Day 15	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.
PD: Change From Baseline in Weight	Baseline, Up to Day 15
PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal	Baseline, Day 2	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.
PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal	Baseline, Day 2	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.
PD: Change From Baseline to Day 2 in Fasting Glucagon	Baseline, Up to Day 2	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.
Number of Participants Developing Anti-LY3084077 Antibodies	Pre-dose, Up to Day 190	The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.
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

Trial Locations

Locations (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