A Study to Compare Two Formulations of LY3209590 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3209590 (Formulation 2); Drug: LY3209590 (Formulation 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05914688

18310

I8H-MC-BDDF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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67 participants in 2 patient groups

LY3209590 (Formulation 1)

Experimental group

Description:

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

Treatment:

Drug: LY3209590 (Formulation 1)

LY3209590 (Formulation 2)

Experimental group

Description:

Single dose of LY3209590 as formulation 2 administered SC.

Treatment:

Drug: LY3209590 (Formulation 2)