Zagociguat

Zagociguat is an investigational therapy. This means it is still being tested in clinical trials.

Study details

PRIZM (NCT06402123).

Adults

Types of mito

MELAS

In development Not recruiting

View PRIZM details

Learn about taking part in clinical trials

Manufacturer

Tisento Therapeutics

Types of mito

Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS)

Which people with mito might this therapy help?

Adults with genetically and clinically defined mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS).

Researchers are studying whether it can help with fatigue, cognitive symptoms and other symptoms of MELAS.

Zagociguat is a tablet taken orally once a day.

What research has been done on this therapy?

Zagociguat has been studied in an earlier Phase 2a study in people with MELAS. The study showed that it was safe and could improve in mitochondrial function, brain blood flow and neuronal function.

Clinical trial information

Study name

PRIZM (NCT06402123).

Location

Australian sites in Sydney and Melbourne. Overseas sites include Canada, Germany, Italy, UK and the U.S.

Who is funding the study?

Tisento Therapeutics.

Adults

Types of mito

MELAS

In development Not recruiting

What is this study about? Who can take part? What therapy is being tested? What does participation involve? Costs and reimbursements Risks and benefits

What is this study about?

This study is testing whether zagociguat is safe and whether it may help adults with MELAS.

The study is looking at whether zagociguat can improve:

fatigue
cognitive function, such as thinking and memory
physical function.

Who can take part?

This study is for adults aged 18 to 75 years with MELAS. People may have been able to join if they had:

a confirmed disease-causing mitochondrial DNA variant
a history of one or more stroke-like episodes
fatigue caused by MELAS
changes in cognitive test results
the ability to complete the study activities and tests.

The study team checks each person’s health and medical history before deciding if they can join.

This study is not currently recruiting new participants.

What therapy is being tested?

What does participation involve?

Costs and reimbursements

Risks and benefits

Possible risks include:

side effects from zagociguat
risks from study tests
changes to usual care during the study.

The study team explains the possible risks before a person decides whether to take part.

Benefits:

People who join may or may not benefit directly. The study may help researchers learn whether zagociguat is safe and whether it may help fatigue, thinking and daily function in people with MELAS.

Learn more about risks and benefits.

Find trial contacts and locations