CompletedPhase 1

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Hepatic impairment

Eligibility highlights

•BMI 18-40•eGFR ≥90•Healthy volunteers

Primary endpoints

•AUCinf•AUClast•Cmax

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 IDNCT06813781

Org study IDD7260C00011

Timeline

Milestones

Study start2024-12-19actual

Study first posted2025-02-07actual

Primary completion2025-10-02actual

Study completion2025-10-02actual

Last update posted2025-10-15actual

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Healthy volunteersHepatic impairment

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

For ALL participants:

•Adults 18-80 years of age

•Weight ≥50kg and BMI between ≥18 to ≤40 kg/m2 For participants with normal hepatic function:

•Participant must be stable on a concomitant medication and/or treatment regimen for at least 2 weeks prior to screening

For Healthy Controls:

-Participant must be medically healthy with no significant findings on medical evaluation at screening to include but not limited to an eGFR >90 ml/min/1.73 m2

For participants with hepatic impairment:

•Group 1 (mild) must have an Child-Pugh score of 5 or 6, Group 2 (moderate) must have a Child-Pugh score of 7 to 9, Group 3 (severe) must have a Child-Pugh score of 10 to 15.

•Participant must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment (eg, no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 30 days prior to study screening

Exclusion criteria

For ALL participants:

•Poorly controlled diabetes mellitus (A1C >10% at screening).

•Unwillingness to use adequate contraception

•Uncontrolled hypertension or hypotension

•Presence of unstable systemic disease or psychologic conditions.

•Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG.

Specific For Healthy Controls:

-Positive screening for HIV, Hepatitis B, or Hepatitis C -

-Any clinically significant disease or disorder to include but not limited to acute or chronic liver disease

Specific For Hepatically Impaired Participants:

•eGFR <60 ml/min/1.73 m2

•Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment to include rising LFTs, paracentesis at less than 4 week intervals, oesophageal banding within the last 3 months, or treatment for GI bleeding within the last 6 months

•Presence of a hepatocellular carcinoma or acute liver disease caused by an infection or drug toxicity.

Endpoints (19)

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

19 endpoints

Primary/protocol endpoint

AUCinf

Time frame:Day 1 to Day 6

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

AUClast

Time frame:Day 1 to Day 6

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:Day 1 to Day 6

Cmax

concentration, descriptive

Secondary/protocol endpoint

Tmax

Time frame:Day 1 to Day 6

Tmax

descriptive

Secondary/protocol endpoint

PK parameters (t1/2λz)

Time frame:Day 1 to Day 6

Half-life

descriptive

Secondary/protocol endpoint

PK parameters CL/F

Time frame:Day 1 to Day 6

descriptive

Secondary/protocol endpoint

PK parameters CLNR/F

Time frame:Day 1 to Day 6

descriptive

Secondary/protocol endpoint

PK parameter Vz/F

Time frame:Day 1 to Day 6

descriptive

Secondary/protocol endpoint

PK parameter CLr

Time frame:Day 1 to Day 6

descriptive

Secondary/protocol endpoint

PK parameter Ae

Time frame:Day 1 to Day 6

descriptive

Secondary/protocol endpoint

Time frame:Day 1 to Day 6

descriptive

Other/protocol endpoint

Number of participants with adverse events (AEs)

Time frame:Day 1 to Day 10

Treatment-emergent AEs (any)

event count, descriptive

Other/protocol endpoint

Participants with abnormal blood pressure

Time frame:Day 1 to Day 6

categorical status, event

Other/protocol endpoint

Number of participants with abnormal laboratory tests results

Time frame:Day 1 to Day 6

descriptive, event

Other/protocol endpoint

Number of participants with serious adverse events (SAEs)

Time frame:Day 1 to Day 10

Serious AEs (any)

event count, event

Other/protocol endpoint

Participants with abnormal ECG QTcF findings

Time frame:Day 1 to Day 6

categorical status, event

Other/protocol endpoint

Participants with abnormal physical examination findings

Time frame:Day 1 to Day 6

descriptive

Other/protocol endpoint

Participants with abnormal heart rate

Time frame:Day 1 to Day 6

threshold achievement, event

Other/protocol endpoint

Number of participants with abnormal ECG PR interval findings

Time frame:Day 1 to Day 6

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.