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

NCT06830629 | Recruiting Phase 2 FDA Drug

• 1 other identifier: MZE829-201
• Study Type: interventional
• Target: 56
• Locations: 3 countries
• Sites: 81

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

Conditions

Proteinuric Kidney Disease

Keywords

APOL1-mediated kidney disease (AMKD); APOL1 kidney disease (AKD)

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability as assessed by incidence of adverse events (AEs)

  Day 1 to Week 12

Secondary Outcomes (2)

• 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

Study Arms (1)

MZE829

EXPERIMENTAL

Cohort 1: Chronic kidney disease with concurrent diabetes Cohort 2: Chronic kidney disease without concurrent diabetes

Drug: MZE829

Interventions

MZE829 DRUG

Capsules for oral administration

MZE829

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maze Therapeutics: lead

Study Sites (81)

Research Site

Decatur, Alabama, 35601, United States

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Huntsville, Alabama, 35805, United States

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Montgomery, Alabama, 36106, United States

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Montgomery, Alabama, 36117, United States

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Granada Hills, California, 91344, United States

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Bloomfield, Connecticut, 06112, United States

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Atlantis, Florida, 33462, United States

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Brandon, Florida, 33511, United States

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Brooksville, Florida, 34613, United States

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Hollywood, Florida, 33024, United States

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Melbourne, Florida, 32901, United States

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Miami Lakes, Florida, 33014, United States

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Orlando, Florida, 32822, United States

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Atlanta, Georgia, 30309, United States

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College Park, Georgia, 30349, United States

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Cordele, Georgia, 31015, United States

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Lithia Springs, Georgia, 30122, United States

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Macon, Georgia, 31210, United States

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Riverdale, Georgia, 30274, United States

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Riverdale, Georgia, 30296, United States

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Savannah, Georgia, 31406, United States

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Snellville, Georgia, 30078, United States

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Chicago, Illinois, 60616, United States

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Chicago, Illinois, 60643, United States

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Kansas City, Kansas, 66112, United States

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Bowling Green, Kentucky, 42101, United States

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Louisville, Kentucky, 40205, United States

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Arnold, Maryland, 21012, United States

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Lutherville, Maryland, 21093, United States

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Oxon Hill, Maryland, 20745, United States

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Dearborn, Michigan, 48126, United States

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Flint, Michigan, 48503, United States

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Pontiac, Michigan, 48341, United States

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Saint Joseph, Michigan, 49085, United States

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Shelby, Michigan, 48092, United States

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Minneapolis, Minnesota, 55404, United States

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Tupelo, Mississippi, 38801, United States

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City of Saint Peters, Missouri, 63376, United States

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St Louis, Missouri, 63103, United States

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Las Vegas, Nevada, 89107, United States

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Buffalo, New York, 14203, United States

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Laurelton, New York, 11413, United States

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Maspeth, New York, 11378, United States

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New York, New York, 10021, United States

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Newburgh, New York, 12550, United States

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Durham, North Carolina, 27708, United States

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Fayetteville, North Carolina, 28304, United States

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Greensboro, North Carolina, 27405, United States

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Shelby, North Carolina, 28150, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43215, United States

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Ardmore, Oklahoma, 73401, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Upland, Pennsylvania, 19013, United States

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Columbia, South Carolina, 29203, United States

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Spartanburg, South Carolina, 29302, United States

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Spartanburg, South Carolina, 29306, United States

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Chattanooga, Tennessee, 37404, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75246, United States

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Greenville, Texas, 75402, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77054, United States

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Houston, Texas, 77099, United States

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McKinney, Texas, 75069, United States

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San Antonio, Texas, 78251, United States

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Shenandoah, Texas, 77384, United States

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Sherman, Texas, 75092, United States

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Norfolk, Virginia, 23504, United States

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Créteil, 94010, France

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Lyon, 69347, France

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Paris, 75015, France

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Paris, 75020, France

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Saint-Ouen, 93400, France

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Leicester, LE5 4PW, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE19RT, United Kingdom

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London, SE59RS, United Kingdom

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Study Officials

• Medical Director

  Maze Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Maze Therapeutics

CONTACT

650-850-5075; APOL1info@mazetx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 17, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); GB (4); US (72)