NCT07226895

A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis

A Study to Explore Changes in Cognitive, Clinical, Biological and Digital Measures Following 8 Weeks of Twice-daily Dosing of MT1988 and to Evaluate Safety & Tolerability of MT1988, in Participants at Clinical High Risk (CHR) for Psychosis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Monument Therapeutics Limited · Industry
• Sex: All
• Age: 17 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn how tests undertaken by people at high risk of developing psychosis (aged 17 to 30 years old) change when those people are given the study drug MT1988 daily for 8 weeks. This will help identify tests that could be used in later trials developing treatments for symptoms in people at high risk of developing psychosis, to measure whether those new treatments are effective. The main question this trial aims to answer is: Can any of the tests (biomarkers) used in this study detect changes in participants dosed with one of two different dose levels of MT1988? Researchers will compare the results from two dose levels of MT1988 to a placebo group. Researchers do not expect to see the test results change in participants taking placebo and this will be compared to changes expected in test results in participants taking MT1988. Participants will: * take a dose of MT1988 or placebo twice per day for 8 weeks * attend clinic appointments every two weeks to undertake assessments * report any side effects they experience to the researchers

Conditions

• Clinical High Risk for Psychosis (CHR)

Interventions

Type	Name	Description
DRUG	MT1988 Low Dose	Oral dosing MT1988; dose level 1
DRUG	MT1988 High Dose	Oral dosing MT1988; dose level 2
DRUG	Placebo	Oral Placebo; blinded to match MT1988 all doses

Timeline

• Start date: 2026-03-03
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2025-11-12
• Last updated: 2026-04-02

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study