A Study to Compare Two Formulations of LY3209590 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3209590 (Formulation 1); Drug: LY3209590 (Formulation 2)

• Registration Number: NCT05914688
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-22
• Study Start: 2023-06-26
• Primary Completion: 2024-01-18
• Study Completion: 2024-01-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3209590 (Formulation 1)	LY3209590 (Formulation 1)	Single dose of LY3209590 as formulation 1 administered subcutaneously (SC).
LY3209590 (Formulation 2)	LY3209590 (Formulation 2)	Single dose of LY3209590 as formulation 2 administered SC.

Primary Outcome Measures

Name	Time	Method
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
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: Maximum Observed Concentration (Cmax) of LY3209590	Predose up to 65 days post dose	PK: Cmax of LY3209590

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore