A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants

NCT ID: NCT04178733

Last Updated: 2025-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2020-05-11

Brief Summary

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This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, 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

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo - SC

Participants received Placebo subcutaneously (SC).

Group Type PLACEBO_COMPARATOR

Placebo - SC

Intervention Type DRUG

Administered SC

0.5 mg LY3493269 IV

Participants received 0.5 mg LY3493269 intravenously (IV).

Group Type EXPERIMENTAL

LY3493269 - IV

Intervention Type DRUG

Administered IV

0.15 mg LY3493269 SC

Participants received 0.15 mg LY3493269 SC.

Group Type EXPERIMENTAL

LY3493269 - SC

Intervention Type DRUG

Administered SC

0.5 mg LY3493269 SC

Participants received 0.5 mg LY3493269 SC.

Group Type EXPERIMENTAL

LY3493269 - SC

Intervention Type DRUG

Administered SC

1.5 mg LY3493269 SC

Participants received 1.5 mg LY3493269 SC.

Group Type EXPERIMENTAL

LY3493269 - SC

Intervention Type DRUG

Administered SC

Interventions

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LY3493269 - SC

Administered SC

Intervention Type DRUG

Placebo - SC

Administered SC

Intervention Type DRUG

LY3493269 - IV

Administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for ease of blood sampling

Exclusion Criteria

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously completed or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have been treated with weight loss medications within 3 months of screening
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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Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Site Status

Countries

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Singapore

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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J1X-MC-GZHA

Identifier Type: OTHER

Identifier Source: secondary_id

17452

Identifier Type: -

Identifier Source: org_study_id

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