A Study of LY3471851 in Healthy Participants

NCT ID: NCT04133116

Last Updated: 2023-11-18

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2020-03-06

Brief Summary

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The main purpose of this study is to explore the safety and tolerability of LY3471851 in healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 7 weeks for each participant.

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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Placebo

Placebo matching LY3471851 administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

LY3471851

Participants received single doses of 450 microgram (μg), 900 μg or 1800 μg LY3471851 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3471851

Intervention Type DRUG

Administered SC

Interventions

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LY3471851

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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NKTR-358

Eligibility Criteria

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Inclusion Criteria

* Are healthy males or females, as determined by medical history and physical examination
* Are first generation Japanese or are Caucasian
* Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at the time of screening

Exclusion Criteria

* Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have an abnormal blood pressure and/or pulse rate as determined by the investigator
* Regularly use known drugs of abuse and/or show positive findings on drug screening
* Are immunocompromised per investigator judgment
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Nektar Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Nektar Therapeutics

Locations

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WCCT Global

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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J1P-MC-KFAI

Identifier Type: OTHER

Identifier Source: secondary_id

17414

Identifier Type: -

Identifier Source: org_study_id

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