A Study of LY3305677 in Healthy Participants

NCT ID: NCT02972645

Last Updated: 2017-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-05

Study Completion Date

2017-07-14

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3305677

Single escalating doses of LY3305677 administered subcutaneously (SC)

Group Type EXPERIMENTAL

LY3305677

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3305677

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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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.

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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16350

Identifier Type: -

Identifier Source: org_study_id

I8P-MC-OXAA

Identifier Type: OTHER

Identifier Source: secondary_id

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