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MZE001

Phase 1

Undisclosed | Small molecule | Other |Maze Therapeutics, Inc.|Trials Updated: Feb 6, 2023

MZE001 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2022

MZE001 target and mechanism

Molecular targetGYS1
Target classEnzyme
ModalitySmall molecule

Also known as MZ1449348

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

MZE001 clinical trials

MZE001 · 1 trial · 1 indication

Phase 1 1
NCT05249621A Randomized Phase 1 of of MZE001 in Healthy VolunteersHealthy
COMPLETED121 Analytics
PHASE1COMPLETED
A Randomized Phase 1 of of MZE001 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Number of participants with adverse events as a measure of safety and tolerability of MZE001
14 days

Occurrence of adverse events, serious adverse events, adverse events of special interest

Secondary Endpoints

Maximum concentration following multiple doses of MZE001
14 days
AUC following multiple doses of MZE001
14 days
Accumulation ratio following multiple doses of MZE001
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MZE001EXPERIMENTALMZE001 is a small molecule inhibitor of muscle glycogen synthase for the potential treatment of Pompe disease.
PlaceboPLACEBO_COMPARATORExcipients containing no active ingredients.

Interventions

NameTypeDescription
MZE001DRUGSmall molecule inhibitor of muscle glycogen synthase
PlaceboDRUGProduct containing excipients with no active ingredients
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and female subjects, ages 18 - 55 years, inclusive; 2. Must provide written informed consent prior to any study assessments and be willing and able to comply with all study procedures; 3. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive; 4. Healthy as determin...

Countries:United States
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Frequently asked questions about MZE001

What is MZE001?

MZE001 is an investigational small molecule developed by Maze Therapeutics, Inc. It is a Phase 1 clinical-stage candidate and has completed one randomized, placebo-controlled trial in healthy volunteers. It has not been approved by the FDA and remains in clinical development.

What does MZE001 target?

MZE001 targets GYS1, an enzyme. By acting on GYS1, the small molecule is designed to modulate the enzyme's activity. GYS1 is the only molecular target identified for MZE001 in its development program.

Who is developing MZE001?

MZE001 is being developed by Maze Therapeutics, Inc., which trades under the ticker MAZE. The company is the sponsor of the drug's clinical program.

What phase is MZE001 in?

MZE001 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for the program.

What clinical trials is MZE001 in?

MZE001 has been studied in one completed Phase 1 trial, NCT05249621, titled a randomized Phase 1 of MZE001 in healthy volunteers. The trial enrolled 121 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.