← Trials/Trial dossier/NCT06003465

CompletedPhase 1

A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

A Relative Bioavailability Study to Compare the Pharmacokinetics of LY3437943 Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

3

Recruiting sites

Enrollment

57

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18.5-32Healthy volunteers

Primary endpoints

Cmax of LY3437943PK: Area Under the Plasma Concentration Versus Time Curve from Zero to TPK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06003465
Org study ID18530
Secondary IDJ1I-MC-GZBXEli Lilly and Company

Timeline

Milestones

Study first posted2023-08-22actual
Study start2023-08-29actual
Primary completion2024-02-08actual
Study completion2024-02-08actual
Last update posted2024-03-29actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive
Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study
Are agreeable to receiving study treatment by injections under the skin
Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized)

Exclusion criteria

Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Smoke more than the equivalent of 10 cigarettes per day
Is a known user of drugs of abuse
Have known allergies to LY3437943 or related compounds

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943

Time frame:Predose up to 43 days postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943

Time frame:Predose up to 43 days postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943

Time frame:Predose up to 43 days postdose

AUC₀–∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.