A Study of LY3461767 in Healthy Participants

NCT ID: NCT04352114

Last Updated: 2021-02-05

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-01-13

Brief Summary

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The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3461767 - Subcutaneous (SC)

LY3461767 administered SC.

Group Type EXPERIMENTAL

LY3461767 - SC

Intervention Type DRUG

Administered SC.

Placebo - SC

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo - SC

Intervention Type DRUG

Administered SC.

LY3461767 - Intravenous (IV)

LY3461767 administered IV.

Group Type EXPERIMENTAL

LY3461767 - IV

Intervention Type DRUG

Administered IV.

Interventions

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LY3461767 - SC

Administered SC.

Intervention Type DRUG

LY3461767 - IV

Administered IV.

Intervention Type DRUG

Placebo - SC

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Are healthy males, or females of non-child-bearing potential
* Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
* Have clinical laboratory tests within normal ranges as judged by investigator
* Have pulse rate and blood pressure within normal ranges as judged by investigator

Exclusion Criteria

* Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
* Regularly use known drugs of abuse
* Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
* Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study
* Smoke more than 10 cigarettes per day
* Are current or former smokers with 30-pack-year smoking history
* Have a diagnosis or history of any malignancy
* Have not had appropriate cancer screening, in accordance with country specific guidance
Minimum Eligible Age

21 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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Covance Clinical Research Inc

Daytona Beach, Florida, United States

Site Status

Covance Dallas

Dallas, Texas, United States

Site Status

Lilly Nus Centre for Clin Pharmacology

Singapore, , Singapore

Site Status

Countries

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United States Singapore

Other Identifiers

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J2L-MC-EZBA

Identifier Type: OTHER

Identifier Source: secondary_id

17517

Identifier Type: -

Identifier Source: org_study_id

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