RecruitingPhase 1

A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

152

Study population

Healthy volunteers, Obesity / overweight, Prediabetes / glucose intolerance, Type 2 diabetes

Eligibility highlights

•BMI 18.5-30•Healthy volunteers

Primary endpoints

•Cmax•Area under concentration-curve from time 0 to the last quantifiable•Area under concentration-time curve from time 0 to infinity (AUCinf)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07723833

Org study IDD7260C00023

Timeline

Milestones

Study first posted2026-07-23actual

Study start2026-07-27actual

Last update posted2026-09-16actual

Primary completion2026-11-18estimated

Study completion2026-11-18estimated

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Healthy volunteersObesity / overweightPrediabetes / glucose intoleranceType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy participants with suitable veins for cannulation or repeated venipuncture.

•All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

•Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.

•Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.

•Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.

•Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.

Exclusion criteria

•History of any clinically important disease or disorder.

•History of acute pancreatitis.

•History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

•Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.

•Any clinically important illness, medical/surgical procedure, or trauma.

•Participants who have previously received elecoglipron within the last 3 months.

Endpoints (12)

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.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

Maximum observed drug concentration (Cmax)

Time frame:At pre-defined intervals from Day 1 to Day 15

concentration, descriptive

Primary/protocol endpoint

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

Time frame:At pre-defined intervals from Day 1 to Day 15

concentration, descriptive

Primary/protocol endpoint

Area under concentration-time curve from time 0 to infinity (AUCinf)

Time frame:At pre-defined intervals from Day 1 to Day 15

concentration, descriptive

Primary/protocol endpoint

Time to reach maximum observed concentration (tmax)

Time frame:At pre-defined intervals from Day 1 to Day 15

time to event, event

Primary/protocol endpoint

Terminal elimination half-life (t1/2λz)

Time frame:At pre-defined intervals from Day 1 to Day 15

concentration, descriptive

Primary/protocol endpoint

Apparent total body clearance (CL/F)

Time frame:At pre-defined intervals from Day 1 to Day 15

concentration, descriptive

Primary/protocol endpoint

Apparent volume of distribution based on the terminal phase (Vz/F)

Time frame:At pre-defined intervals from Day 1 to Day 15

descriptive

Primary/protocol endpoint

Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)

Time frame:At pre-defined intervals from Day 1 to Day 15

ratio, event

Primary/protocol endpoint

Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)

Time frame:At pre-defined intervals from Day 1 to Day 15

ratio, event

Primary/protocol endpoint

Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)

Time frame:At pre-defined intervals from Day 1 to Day 15

concentration, descriptive

Secondary/protocol endpoint

Number of participants with adverse events (AEs)

Time frame:From screening (Day -28) up to follow-up visit (Day 18-Day 22)

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Terminal elimination rate constant (λz)

Time frame:At pre-defined intervals from Day 1 to Day 15

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.