- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972645
A Study of LY3305677 in Healthy Participants
A First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects
The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it.
This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it.
This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).
Participation in this study is expected to last up to 16 weeks.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Leeds, United Kingdom, LS2-9LH
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Overtly healthy as determined by medical history and physical examination
- Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product
- Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
- First generation Japanese participants or non-Japanese participants
- Have a body weight of more than 50 kilograms (kg)
Exclusion Criteria:
- Have participated within the last 3 months in a clinical trial involving an investigational product
- Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy
- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1
- Have undergone any form of bariatric surgery
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
- Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase
- Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C
- Have used or intend to use medications that promote weight loss
- Have donated blood of more than 500 milliliter (mL) within the last month
- Currently smoke more than 10 cigarettes per day
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: LY3305677
Single escalating doses of LY3305677 administered subcutaneously (SC)
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Administered SC
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PLACEBO_COMPARATOR: Placebo
Placebo administered SC
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Administered SC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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: Baseline to Study Completion (approximately 16 weeks)
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Baseline to Study Completion (approximately 16 weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677
Time Frame: Day 1 Pre-dose through Day 85
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Day 1 Pre-dose through Day 85
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Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677
Time Frame: Day 1 Pre-dose through Day 85
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Day 1 Pre-dose through Day 85
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16350
- I8P-MC-OXAA (OTHER: 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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