A Study of Two Different Formulations of LY3209590 in Healthy Participants

Comparative Pharmacokinetics of LY3209590 After Administration of a Lyophilized Formulation and a Solution Formulation in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04768842

Enrollment

Registered

2021-02-24

Start date

2021-03-03

Completion date

2021-09-03

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.

Interventions

DRUGLY3209590

Administered SC.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Are overtly healthy males or non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy * Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening * Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study * Have veins suitable for blood sampling * Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion criteria

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Are women who are pregnant or lactating * Have a history of multiple and/or severe allergic reactions * Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive * Regularly use known drugs of abuse or with positive drug results

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590	Predose on Day 1 through Day 65	PK: Cmax of LY3209590
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590	Predose on Day 1 through Day 65	PK: AUC(0-inf) of LY3209590

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026