A Study to Compare Two Formulations of LY3209590 in Healthy Participants

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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-26

Study Completion Date

2024-01-18

Brief Summary

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The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated.

Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3209590 (Formulation 1)

Single dose of LY3209590 as formulation 1 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3209590 (Formulation 1)

Intervention Type DRUG

Administered SC.

LY3209590 (Formulation 2)

Single dose of LY3209590 as formulation 2 administered SC.

Group Type EXPERIMENTAL

LY3209590 (Formulation 2)

Intervention Type DRUG

Administered SC.

Interventions

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LY3209590 (Formulation 1)

Administered SC.

Intervention Type DRUG

LY3209590 (Formulation 2)

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female participants who are overtly healthy as determined by medical evaluation
* Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
* Contraceptive use by participants should be consistent with local regulations

Exclusion Criteria

* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have known allergies to LY3209590, related compounds, or any components of the formulation
* Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Are lactating or pregnant

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes