A Study of LY3848575 in Healthy Participants

NCT ID: NCT05727072

Last Updated: 2024-04-04

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-10

Study Completion Date

2024-02-19

Brief Summary

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The main purpose of this study is to evaluate the safety and tolerability of LY3848575 when administered either intravenously or subcutaneously in single ascending or multiple doses in healthy non-Japanese and first generation Japanese participants. The study will also assess how fast LY3848575 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 142 days excluding the screening period of 28 days.

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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LY3848575 IV

Single ascending doses of LY3848575 administered intravenously (IV).

Group Type EXPERIMENTAL

LY3848575

Intervention Type DRUG

Administered IV.

Placebo IV

Placebo administered IV.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV.

LY3848575 SC

Multiple doses of LY3848575 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3848575

Intervention Type DRUG

Administered SC.

Placebo SC

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Interventions

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LY3848575

Administered IV.

Intervention Type DRUG

LY3848575

Administered SC.

Intervention Type DRUG

Placebo

Administered IV.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants who are overtly healthy as determined by medical evaluation
* Have body weight of at least 50 kilograms (kg) for males and 40 kg for females, and body mass index of 18 to 30 kilograms per meter squared (kg/m²), inclusive
* For cohorts with Japanese participants: To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan

Exclusion Criteria

* Are currently enrolled in any other 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 participated, within the last 3 months, in a clinical study involving an IP.
Minimum Eligible Age

18 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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Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Countries

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United States

Other Identifiers

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J4F-MC-CYAA

Identifier Type: OTHER

Identifier Source: secondary_id

18589

Identifier Type: -

Identifier Source: org_study_id

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