A Study of LY3305677 in Healthy Participants

July 21, 2017 updated by: Eli Lilly and Company

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

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

      • 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.

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

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LY3305677
Single escalating doses of LY3305677 administered subcutaneously (SC)
Administered SC
PLACEBO_COMPARATOR: Placebo
Placebo administered SC
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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: Baseline to Study Completion (approximately 16 weeks)
Baseline to Study Completion (approximately 16 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677
Time Frame: Day 1 Pre-dose through Day 85
Day 1 Pre-dose through Day 85
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677
Time Frame: Day 1 Pre-dose through Day 85
Day 1 Pre-dose through Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (ACTUAL)

December 5, 2016

Primary Completion (ACTUAL)

July 14, 2017

Study Completion (ACTUAL)

July 14, 2017

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (ESTIMATE)

November 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

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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