Recruiting

AZD4248 for Chronic Kidney Disease and Type 2 Diabetes

What is being tested

AZD4248

+ Placebo

Drug

Who is being recruted

Urogenital Diseases+17

+ Chronic Disease

+ Diabetes Mellitus

From 18 to 75 Years

+34 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: June 2025

See protocol details

Summary

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: March 21, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 9, 2025

Actual date on which the first participant was enrolled.

This clinical trial is investigating a new drug called AZD4248, which is being tested to see if it is safe and how it behaves in the body. The study involves both healthy participants and those who have chronic kidney disease along with type 2 diabetes. The goal is to understand how the body processes this drug and its effects, especially for those with kidney-related health issues. This research is essential because it could lead to new treatments for kidney disease and diabetes, potentially improving patient care and filling gaps in current treatment options. Participants in the study will receive AZD4248 in different forms and amounts. Healthy participants in Parts A and B receive either single or multiple doses, including some participants of specific ethnic backgrounds. Those with kidney disease and diabetes will receive multiple doses in Part C. Another group in Part D will measure their creatinine levels at home to see if these home tests are reliable. The trial is carefully controlled and monitored to ensure participant safety and gather accurate data on how the drug works, with participants receiving either the drug or a placebo for comparison.

Official TitleA Phase I Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 Following Single and Multiple Ascending Dose Administration in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Prospective, Non-interventional Cohort Study

NCT07024823

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: March 21, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseDiabetes MellitusDiabetes Mellitus, Type 2Diabetic NephropathiesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesGlucose Metabolism DisordersDiabetes ComplicationsRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

14 inclusion criteria required to participate

Have a diagnosis of diabetic kidney disease (DKD)

Have a diagnosis of DKD as defined by a) diagnosis of type 2 diabetes (T2D) b) eGFR values and c) urine albumin to creatinine ratio (UACR) values

Participants are required to be on a stable dose of ACEi or ARB for at least 6 weeks prior to Visit 1 and throughout the Screening Period. In addition, participants should be on stable doses of all other medication for >= 6 weeks before Screening

Have a body mass index (BMI) between 18 and 30 kilograms per millimeter (kg/m2), inclusive

Show More Criteria

20 exclusion criteria prevent from participating

Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention

New York Heart Association Class 2, 3, or 4 or history of hospitalization for heart failure within 6 months of screening

Severe chronic obstructive pulmonary disease as judged by the Investigator or hospitalization for exacerbation in the last 6 months

History or presence of gastrointestinal, hepatic, or renal disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive single ascending oral dose of AZD4248 or placebo.

Group II

Experimental

Participants will receive single oral dose of AZD4248 or placebo.

Group III

Experimental

Participants will receive multiple ascending oral doses of AZD4248 or placebo.

Group IV

Experimental

Participants will receive multiple ascending oral doses of AZD4248 or placebo.

Group 5

Experimental

Participants will receive multiple oral doses of AZD4248 or placebo.

Group 6

Experimental

Participants will receive single IV infusion of AZD4248 or placebo.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Research Site

Glendale, United StatesOpen Research Site in Google Maps

Recruiting

Research Site

Chicago, United States

Recruiting

Research Site

Ann Arbor, United States

Recruiting

Research Site

Saint Paul, United States

Recruiting

5 Study Centers