A Relative Bioavailability Study of LY3454738 in Healthy Participants

A Phase 1, Open-Label Study to Determine the Relative Bioavailability of LY3454738 in Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06173895

Enrollment

Registered

2023-12-18

Start date

2024-01-12

Completion date

2024-05-02

Last updated

2024-05-30

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, LY3454738 that gets into the blood stream and how long it takes the body to get rid of it when given under the skin comparing a test formulation versus a reference formulation in healthy participants. The study will also evaluate the safety and tolerability of LY3454738 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening period.

Interventions

DRUGLY3454738

Administered subcutaneously (SC)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Participants who are overtly healthy as determined by medical history and physical examination. * Have body mass index (BMI) between 18.0 and 28.0 kilograms per meter squared (kg/m²), inclusive, at screening.

Exclusion criteria

* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data. * Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening or intend to during the study. * Show evidence of active or latent TB. * Have one of the following infections: hepatitis B virus or human immunodeficiency virus (HIV). * Participants must not be currently participating in or completed a clinical trial within the last 30 days

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738	Predose on day 1 up to 85 days post dose	PK: Cmax of LY3454738
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3454738	Predose on day 1 up to 85 days post dose	PK: AUC of LY3454738

Countries

United States

Outcome results

None listed

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