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

July 23, 2026 updated by: Maze Therapeutics

An Open-Label Phase 2 Study to Evaluate the Safety, Tolerability, and Effect on Albuminuria of MZE829 in Adults With Proteinuric Chronic Kidney Disease and the APOL1 High Risk Genotype

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Créteil, France, 94010
        • Recruiting
        • Research Site
      • Lille, France, 59037
        • Recruiting
        • Research Site
      • Lyon, France, 69347
        • Recruiting
        • Research Site
      • Paris, France, 75020
        • Recruiting
        • Research Site
      • Paris, France, 75015
        • Recruiting
        • Research Site
      • Paris, France, 75018
        • Recruiting
        • Research Site
      • Saint-Ouen, France, 93400
        • Recruiting
        • Research Site
  • United Kingdom
      • Leicester, United Kingdom, Le5 4PW
        • Recruiting
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Research Site
      • London, United Kingdom, SE19RT
        • Recruiting
        • Research Site
      • London, United Kingdom, SE59RS
        • Recruiting
        • Research Site
  • United States
    • Alabama
      • Decatur, Alabama, United States, 35601
        • Recruiting
        • Research Site
      • Huntsville, Alabama, United States, 35805
        • Recruiting
        • Research Site
      • Montgomery, Alabama, United States, 36106
        • Recruiting
        • Research Site
      • Montgomery, Alabama, United States, 36117
        • Recruiting
        • Research Site
    • Connecticut
      • Bloomfield, Connecticut, United States, 06112
        • Recruiting
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20060
        • Recruiting
        • Research Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • Research Site
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Research Site
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Research Site
      • Melbourne, Florida, United States, 32901
        • Recruiting
        • Research Site
      • Orlando, Florida, United States, 32822
        • Recruiting
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Research Site
      • College Park, Georgia, United States, 30349
        • Recruiting
        • Research Site
      • Cordele, Georgia, United States, 31015
        • Recruiting
        • Research Site
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Research Site
      • Riverdale, Georgia, United States, 30274
        • Recruiting
        • Research Site
      • Riverdale, Georgia, United States, 30296
        • Recruiting
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Research Site
      • Snellville, Georgia, United States, 30078
        • Recruiting
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Recruiting
        • Research Site
      • Chicago, Illinois, United States, 60616
        • Recruiting
        • Research Site
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Recruiting
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Recruiting
        • Research Site
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Research Site
    • Maryland
      • Arnold, Maryland, United States, 21012
        • Recruiting
        • Research Site
      • Lutherville, Maryland, United States, 21093
        • Recruiting
        • Research Site
      • Oxon Hill, Maryland, United States, 20745
        • Recruiting
        • Research Site
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Research Site
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Research Site
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Research Site
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Research Site
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Research Site
      • St Louis, Missouri, United States, 63103
        • Recruiting
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89107
        • Recruiting
        • Research Site
    • New Jersey
      • Jersey City, New Jersey, United States, 07305
        • Recruiting
        • Research Site
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Research Site
      • Laurelton, New York, United States, 11413
        • Recruiting
        • Research Site
      • Maspeth, New York, United States, 11378
        • Recruiting
        • Research Site
      • Newburgh, New York, United States, 12550
        • Recruiting
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Recruiting
        • Research Site
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Research Site
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Research Site
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Research Site
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Research Site
    • Oklahoma
      • Ardmore, Oklahoma, United States, 73401
        • Recruiting
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Research Site
      • Upland, Pennsylvania, United States, 19013
        • Recruiting
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Research Site
      • Spartanburg, South Carolina, United States, 29306
        • Recruiting
        • Research Site
      • Spartanburg, South Carolina, United States, 29302
        • Recruiting
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Research Site
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Research Site
      • Greenville, Texas, United States, 75402
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77099
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77054
        • Recruiting
        • Research Site
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Research Site
      • San Antonio, Texas, United States, 78251
        • Recruiting
        • Research Site
      • Shenandoah, Texas, United States, 77384
        • Recruiting
        • Research Site
      • Sherman, Texas, United States, 75092
        • Recruiting
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23504
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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 active cancer within past 2 years, except 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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MZE829

Cohort 1: Chronic kidney disease with concurrent diabetes

Cohort 2: Chronic kidney disease without concurrent diabetes
Drug: MZE829
Capsules for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability as assessed by incidence of adverse events (AEs)
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent participants with ≥30% reduction from baseline in UACR at Week 12
Time Frame: Baseline to Week 12
Baseline to Week 12
Geometric mean plasma drug concentrations
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maze Therapeutics

Investigators

  • Study Director: Medical Director, Maze Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZE829-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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