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A Phase 2b Study of Zagociguat in Patients With MELAS

NCT06402123 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-03-25

No results posted yet for this study

Summary

PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs. placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS.

Conditions

  • Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)

Interventions

DRUG

zagociguat 15mg

Once-daily oral tablets

DRUG

zagociguat 30mg

Once-daily oral tablets

DRUG

Placebo

Once-daily oral tablets

Sponsors & Collaborators

  • Tisento Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2026-06-20
Completion
2026-06-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402123 on ClinicalTrials.gov