A Study of Multiple Doses of LY3305677 in Healthy Participants

NCT ID: NCT03325387

Last Updated: 2018-08-16

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2018-08-03

Brief Summary

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The purposes of this study are to determine:

* The safety of LY3305677 and any side effects that might be associated with it.
* How much LY3305677 gets into the bloodstream and how long it takes the body to remove it in healthy participants, including those of Japanese origin.
* The effect LY3305677 has on the body, particularly the effect on blood glucose levels.

This study will last approximately 17 weeks not including screening. Screening is required within 4 weeks prior to start of the study.

This study is for research purposes only and is not intended to treat any medical conditions.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3305677

Escalating doses of LY3305677 administered by subcutaneous (SC) injection

Group Type EXPERIMENTAL

LY3305677

Intervention Type DRUG

Administered SC

Placebo

Saline solution administered by SC injection

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

* Are overtly healthy males or females, as determined by medical history and physical examination
* Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
* Are first-generation Japanese or non-Japanese. First-generation Japanese is defined as the participant, the participant's biological parents, and all of the participant's grandparents are of exclusive Japanese descent and have been born in Japan
* Have a body weight of more than 54 kilograms (kg)

Exclusion Criteria

* Currently enrolled in a clinical study or have participated in a study within the past 3 months
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
* Have history of pancreatitis
* Have known or ongoing psychiatric disorders
* Have undergone bariatric surgery or have used any drugs for weight loss
* Have a history of alcoholism
* Currently smoke more than 10 cigarettes a 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, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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I8P-MC-OXAB

Identifier Type: OTHER

Identifier Source: secondary_id

16619

Identifier Type: -

Identifier Source: org_study_id

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