- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01846702
A Study of LY3084077 in Healthy Participants
October 21, 2017 updated by: Eli Lilly and Company
A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3084077 in Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore, 117597
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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- Have previously completed or withdrawn from this study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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Single dose of placebo matching LY3084077 administered subcutaneously (SC).
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Given as a SC injection.
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Experimental: LY3084077
Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC.
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Given as a SC injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Pre-dose, Up to Day 190
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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.
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Pre-dose, Up to Day 190
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077
Time Frame: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
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Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
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PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077
Time Frame: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
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Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose
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Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides
Time Frame: Baseline, Up to Day 15
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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.
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Baseline, Up to Day 15
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PD: Change From Baseline in Fasting Insulin
Time Frame: Baseline, Up to Day 15
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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.
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Baseline, Up to Day 15
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PD: Change From Baseline in Weight
Time Frame: Baseline, Up to Day 15
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Baseline, Up to Day 15
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PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal
Time Frame: Baseline, Day 2
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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.
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Baseline, Day 2
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PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal
Time Frame: Baseline, Day 2
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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.
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Baseline, Day 2
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PD: Change From Baseline to Day 2 in Fasting Glucagon
Time Frame: Baseline, Up to Day 2
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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.
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Baseline, Up to Day 2
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Number of Participants Developing Anti-LY3084077 Antibodies
Time Frame: Pre-dose, Up to Day 190
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The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.
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Pre-dose, Up to Day 190
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (Estimate)
May 3, 2013
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
October 21, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 14530
- I6P-MC-FMRA (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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