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

Phase 2

Recruiting

• Conditions: Proteinuric Kidney Disease
• Interventions: Drug: MZE829

• Registration Number: NCT06830629
• Lead Sponsor: Maze Therapeutics

Brief Summary

This is purpose of this study is to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with APOL1 Kidney Disease

Detailed Description

An open-label Phase 2 study is designed to evaluate the safety, tolerability, and effect on Albuminuria of MZE829 in Adults with Proteinuric Chronic Kidney Disease and the APOL1 High Risk Genotype.

Study Timeline

• Study Start: 2025-02-05
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-17
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-09-03
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• APOL1 high risk genotype of G1/G1, G2/G2, or G1/G2
• Chronic kidney disease with persistent albuminuria

Key

Exclusion Criteria

• Organ or bone marrow transplantation
• History of cancer within past 2 years, excepted for treated non-melanoma skin cancer, stage 0 cervical cancer, or stage 1 prostate cancer
• Conditions that may alter drug absorption, e.g., history of bariatric surgery
• Type I diabetes
• Pregnant or currently nursing

Other inclusion/exclusion criteria defined in protocol apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MZE829	MZE829	Cohort 1: Chronic kidney disease with concurrent diabetes Cohort 2: Chronic kidney disease without concurrent diabetes

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as assessed by incidence of adverse events (AEs)	Day 1 to Week 12

Secondary Outcome Measures

Name	Time	Method
Percent participants with ≥30% reduction from baseline in UACR at Week 12	Day 1 to Week 12
Geometric mean plasma drug concentrations	Day 1 to Week 12

Trial Locations

Locations (2)

Research Site; 🇺🇸 Norfolk, Virginia, United States

Clinical Renal Associates; 🇺🇸 Upland, Pennsylvania, United States