GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Phase I Study to Investigate the Effect of Renal 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 Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criteria

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

Primary endpoints

•AUCinf•AUClast•Cmax

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 IDNCT06742762

Org study IDD7260C00006

Timeline

Milestones

Study start2024-12-17actual

Study first posted2024-12-19actual

Primary completion2025-04-20actual

Study completion2025-04-20actual

Last update posted2025-06-08actual

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Adults 18-80 years of age

•Weight >50kg and BMI between 18-40 kg/m2

For participants with normal renal function:

-Participant must be medically healthy with no significant findings on medical evaluation and an eGFR ≥90 ml/min at screening.

For participants with renal impairment:

Group 1 (severe) must have an eGFR <30 ml/min and Group 3 (moderate) must have an eGFR 30 to <60 ml/min based on CKD-EPI calculations for at least 6 months prior to enrollment.

Exclusion criteria

•Poorly controlled diabetes mellitus (A1C >10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia).

•Unwillingness to use adequate contraception

•Uncontrolled hypertension or hypotension.

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

•Presence of unstable systemic disease or psychologic conditions. Abnormal laboratory values to include but not limited to liver function tests (thresholds differ for renal impairment and health controls)

•Any change in baseline medication within 2 weeks of planned study initiation.

Endpoints (14)

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

14 endpoints

Primary/protocol endpoint

AUCinf

Time frame:Day 1 to Day 5

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUClast

Time frame:Day 1 to Day 5

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:Day 1 to Day 5

Cmax

concentration, descriptive

Secondary/protocol endpoint

Tmax

Time frame:Day 1 to Day 5

Tmax

descriptive

Secondary/protocol endpoint

PK parameter t1/2λz

Time frame:Day 1 to Day 5

Half-life

descriptive

Secondary/protocol endpoint

PK parameter CL/F

Time frame:Day 1 to Day 5

descriptive

Secondary/protocol endpoint

PK parameter CLNR/F

Time frame:Day 1 to Day 5

descriptive

Secondary/protocol endpoint

PK parameter Vz/F

Time frame:Day 1 to Day 5

descriptive

Secondary/protocol endpoint

PK parameter CLr

Time frame:Day 1 to Day 5

descriptive

Secondary/protocol endpoint

PK parameter Ae

Time frame:Day 1 to Day 5

descriptive

Secondary/protocol endpoint

Time frame:Day 1 to Day 5

descriptive

Other/protocol endpoint

Number of participants with adverse events (AEs)

Time frame:Day 1 to Day 10

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings

Time frame:Day 1 to Day 5

event count, event

Other/protocol endpoint

Number of participants with abnormal laboratory tests results

Time frame:Day 1 to Day 5

event count, event

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.