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OpenTrials
Completed

NCT Number: NCT05914688

A Study to Compare Two Formulations of LY3209590 in Healthy Participants

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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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3209590 (Formulation 1)

Drug

Administered SC.

LY3209590 (Formulation 2)

Drug

Administered SC.

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590

    Time frame: Predose up to 65 days post dose

    PK: AUC(0-tlast) of LY3209590

  2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590

    Time frame: Predose up to 65 days post dose

    PK: AUC(0-∞) of LY3209590

  3. PK: Maximum Observed Concentration (Cmax) of LY3209590

    Time frame: Predose up to 65 days post dose

    PK: Cmax of LY3209590

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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