GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234

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 AZD6234

Lead sponsor

AstraZeneca

Asset

AZD6234

Subcutaneous · Amylin analog

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

•AUClast•AUCinf•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 IDNCT06845813

Org study IDD8750C00007

Timeline

Milestones

Study start2025-02-24actual

Study first posted2025-02-25actual

Primary completion2025-09-30actual

Study completion2025-09-30actual

Last update posted2025-11-03actual

Assets

Investigational agents

AZD6234

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participant must be 18 to 85 years of age, inclusive, at the time of signing the informed consent.

•Body weight ≥ 50 kg; BMI within the range of ≥ 18 to ≤ 40 kg/m2, as measured at screening.

Healthy Matched Control Participants:

•Participant must be medically healthy with no clinically significant medical history, or abnormalities in physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1.

•Have an eGFR of ≥ 90 mL/min determined at screening.

Renally-impaired Participants:

•Diagnosis of chronic kidney disease, stable renal function in the 3 months prior to dosing,

•Participants with renal impairment based on BSA-adjusted CKD-EPI equation at screening.

•All renally-impaired participants should be on a stable dose of cardio-renal relevant treatment for at least 2 weeks prior to screening.

•If participants with renal impairment have diabetes mellitus, it must be controlled

•Female(s) of childbearing potential: must use adequate contraception. Oral contraceptives are not permitted as there is a potential effect of the IMP on the absorption of oral drugs.

•Male Participants: Condom use is required for the duration of the study and until at least 28 days after the last dose of IMP. Additional contraception must be used for the sexual partners of male study participants throughout the clinical trial and for 28 days following the last dose of IMP.

Exclusion criteria

- History or presence of: significant GI disease or previous upper GI surgery

•Clinically significant cardiovascular disease, as judged by the investigator, d. Neuromuscular or neurogenic disease e. Severe vitamin D deficiency < 12 ng/dL.

•History or presence of any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs

•History of psychosis, bipolar disorder

•History of major depressive disorder within the past 2 years

•History of suicide attempt or history of suicidal ideation within the past year.

Healthy Matched Control Participants:

•History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.

•Use of any prescription or non-prescription drugs, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.

Renally-impaired Participants:

•Presence of unstable medical condition or any evidence of additional severe or uncontrolled systemic disease or laboratory finding which, in the opinion of the investigator, would compromise the participant's safety or successful participation in this study.

•Renal transplant patients, participants waiting for organ transplant scheduled to occur during the study, and those with a history of acute kidney injury occurring within 3 months prior to screening. Nonfunctioning renal allografts are allowed.

•Use of concurrent medication which affects calculation of eGFR by affecting serum creatinine within 7 days of Day -1.

•Unable to refrain from phosphate binders, cholestyramine/colestipol, and ranitidine/nizatidine within 10 hours before and 10 hours after study intervention.

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

AUClast

Time frame:Day 1 to Day 36

descriptive

Primary/protocol endpoint

AUCinf

Time frame:Day 1 to Day 36

descriptive

Primary/protocol endpoint

Cmax

Time frame:Day 1 to Day 36

concentration, descriptive

Secondary/protocol endpoint

Tmax

Time frame:Day 1 to Day 36

concentration, descriptive

Secondary/protocol endpoint

PK parameter (t1/2λz)

Time frame:Day 1 to Day 36

concentration, descriptive

Secondary/protocol endpoint

PK parameter (CL/F)

Time frame:Day 1 to Day 36

descriptive

Secondary/protocol endpoint

PK parameter (Vz/F)

Time frame:Day 1 to Day 36

descriptive

Secondary/protocol endpoint

Number of participants with adverse events (AEs)

Time frame:Day 1 to Day 54

event count, event

Secondary/protocol endpoint

Number of participants with abnormal vital signs

Time frame:Day 1 to Day 54

event count, event

Secondary/protocol endpoint

Number of participants with abnormal ECGs

Time frame:Day 1 to Day 54

event count, event

Secondary/protocol endpoint

Number of participants with abnormal physical examination findings

Time frame:Day 1 to Day 54

event count, event

Secondary/protocol endpoint

Number of participants with abnormal laboratory test results

Time frame:Day 1 to Day 54

event count, event

Secondary/protocol endpoint

Number of participants with confirmed positive anti-drug antibody testing

Time frame:Day 1 to Day 54

event count, event

Secondary/protocol endpoint

Number of participants with serious adverse events (SAEs)

Time frame:Day 1 to Day 54

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.