A Study to Compare Two Formulations of LY3209590 in Healthy Participants

A Bioequivalence Study of Subcutaneous Injections of LY3209590 in Two Formulations in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05914688

Enrollment

Registered

2023-06-22

Start date

2023-06-26

Completion date

2024-01-18

Last updated

2024-04-23

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

Conditions

Healthy

Keywords

Pharmacokinetics, Formulation, Bioavailability

Brief summary

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.

Interventions

DRUGLY3209590 (Formulation 1)

Administered SC.

DRUGLY3209590 (Formulation 2)

Administered SC.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590	Predose up to 65 days post dose	PK: AUC(0-tlast) of LY3209590
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590	Predose up to 65 days post dose	PK: AUC(0-∞) of LY3209590
PK: Maximum Observed Concentration (Cmax) of LY3209590	Predose up to 65 days post dose	PK: Cmax of LY3209590

Countries

Singapore

Outcome results

None listed

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