A Phase 2 Study of MZE829 in Adults with APOL1 Kidney Disease

Start 15 Sep 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 8 sites · Protocol MZE829-201

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruiting

Participants planned 68

Countries 1

Sites 8

APOL1 Kidney Disease (AKD)

To evaluate the safety and tolerability of MZE829 in adults with proteinuric APOL1 kidney disease

Key facts

Sponsor: Maze Therapeutics Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Phenomena and Processes [G] - Genetic Phenomena [G05]
Trial duration: 15 Sep 2025 → ongoing
Decision date (initial): 2025-06-25
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Maze Therapeutics

External identifiers

EU CT number: 2024-517525-10-00
ClinicalTrials.gov: NCT06830629

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Pharmacokinetic, Others, Safety

To evaluate the safety and tolerability of MZE829 in adults with proteinuric APOL1 kidney disease

Conditions and MedDRA coding

APOL1 Kidney Disease (AKD)

Version	Level	Code	Term	System organ class
25.1	PT	10087686	APOL1-mediated kidney disease	100000004857

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

18 to 68 years of age (inclusive) at the time of signing the informed consent
Being of recent African descent (e.g., African American, Afro-Caribbean, Afro-Latinx, or African ancestry), regardless of current racial or self-identification
Body mass index (BMI) of 18 to ≤45 kg/m2 and total body weight of ≥40 kg
Confirmed APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
Diagnosis of chronic kidney disease with persistent high urine albuminuria
Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 at Screening based on the Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI Creatinine-Cystatin C) equation
History of proteinuria

Exclusion criteria 5

Any condition that in the opinion of the Investigator would interfere with the evaluation of the investigational product or lead to increased risk of harm
Use of any potent immunosuppressants within 5 PK half-lives or 12 weeks prior to Screening, whichever is longer
Use of oral corticosteroids equivalent to prednisone >10 mg/day for more than 1 day or any use of systemic corticosteroids equivalent to prednisone >10 mg within approximately 8 weeks prior to Screening
Clinically significant abnormal laboratory test results with the exception of abnormalities considered by the Investigator to be the result of underlying disease.
Clinically significant abnormal Screening ECG, including but not limited to QTcF >450 ms or history of QT interval prolongation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Safety and tolerability based on incidence of adverse events (AEs), and changes in vital signs, clinical laboratory assessments, 12-lead electrocardiograms (ECGs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

MZE829

PRD11756822 · Product

Active substance: MZE829
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 999999 mg milligram(s)
Max total dose: 999999 mg milligram(s)
Max treatment duration: 84 Day(s)
Authorisation status: Not Authorised
MA holder: MAZE THERAPEUTICS, INC.
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Maze Therapeutics Inc.

Sponsor organisation: Maze Therapeutics Inc.
Address: 171 Oyster Point Boulevard Suite 300
City: South San Francisco
Postcode: 94080-2013
Country: United States

Scientific contact point

Organisation: Maze Therapeutics Inc.
Contact name: Maze Clinical Lead

Public contact point

Organisation: Maze Therapeutics Inc.
Contact name: Maze Clinical Lead

Third parties 8

Organisation	City, country	Duties
Syneos Health Inc. ORG-100008382	Morrisville, United States	On site monitoring, Code 10, Code 12, Other, Code 5, Data management, E-data capture, Code 8
The Doctors Laboratory Limited ORG-100012670	London, United Kingdom	Other
Alturas Analytics Inc. ORG-100045347	Moscow, United States	Other
Medidata Solutions Inc. ORG-100016256	New York, United States	E-data capture
Suvoda LLC ORG-100043523	Conshohocken, United States	Interactive response technologies (IRT)
Precision For Medicine Inc. ORG-100041895	Frederick, United States	Other, Laboratory analysis
Nephropathology Associates PLC ORG-100044668	Little Rock, United States	Other
PPD Global Central Labs ORG-100046496	Zaventem, Belgium	Laboratory analysis

Locations

1 EU/EEA country · 8 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	14	8
Rest of world United Kingdom, United States	—	54	—