Phase 2b Randomized, Placebo-Controlled Trial Investigating Zagociguat in MELAS

PRIZM Study Overview

PRIZM is a Phase 2b study A Phase 2b study evaluates the effectiveness and safety of dose levels of an investigational medicine investigating whether zagociguat improves fatigue (lack of energy), cognitive impairment (eg, problems with memory, difficulty concentrating), and other symptoms in people living with MELAS.

Study Design

PRIZM is a blindedA trial where neither the participant nor the study team know if the participant is taking placebo or active drug at any given time , placebo-controlledA trial in which a substance that has no therapeutic effect (called a “placebo”) is used as a comparison (control) to measure the effectiveness of an active medication , crossoverA trial in which participants receive different treatments during different periods of the study study with two treatment periods separated by a washoutThe time between treatment periods when participants do not take any study medication and it and it leaves (or is “washed out” of) their system period. Half of the eligible participants will receive zagociguat in period 1 and then placebo Inactive tablet that looks just like the active medication in period 2, and the other half will receive placebo in period 1 and then zagociguat in period 2.

Study Features

About Zagociguat

Zagociguat is an investigational medicine that is taken as a once-a-day oral tablet.

Zagociguat has been studied in 5 clinical trials, including a Phase 2a trial in participants with MELAS.

What’s in a Name?

A prism is a multi-faceted piece of glass that enables us to see and examine the many components of light. In the same way, PRIZM is designed to evaluate the impact of zagociguat’s multi-faceted mechanism of action on the symptoms of MELAS identified by those living with this complex disease.

Eligibility

To be considered for participation in PRIZM, individuals must:

- Be 18 to 75 years of age
- Have a mitochondrial DNA mutation
- Have a history of stroke-like episode(s)
- Experience fatigue and cognitive issues

Final eligibility will be determined by the study doctor.

For More Information

To learn more about PRIZM, contact study staff directly using the contact information provided on clinicaltrials.gov (NCT06402123) or email PRIZM@tisentotx.com.