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RECRUITING Phase 1

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

NCT07226895 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • DRUG Placebo
  • DRUG MT1988 Low Dose
  • DRUG MT1988 High Dose

Study Locations (15)

California

  • University of California, Irvine — Irvine
  • University of California — Los Angeles
  • University of California, San Francisco — San Francisco

New York

  • Northwell Health — Glen Oaks
  • Columbia University — New York
  • Icahan School of Medicine at Mount Sinai — New York

Pennsylvania

  • University of Pennsylvania — Philadelphia
  • Temple University — Philadelphia
  • University of Pittsburgh School of Medicine — Pittsburgh

Connecticut

  • Yale University Conneticut Mental Health Center — New Haven

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

Missouri

  • Washington University — St Louis

North Carolina

  • University of North Carolina at Chapel Hill — Chapel Hill

Ohio

  • Ohio State University — Columbus

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2026-03
Est. Completion 2027-04
Phase Phase 1

Sponsor

Monument Therapeutics Limited

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07226895

The ClinicalTrials.gov registry entry for NCT07226895 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Monument Therapeutics Limited, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Clinical High Risk for Psychosis (CHR) appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07226895 reports 15 study locations spanning 9 distinct geographic areas — top geographies include California, New York, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07226895 about?

NCT07226895 is a clinical study titled "A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis". 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...

What is the current status of trial NCT07226895?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2026-03. Estimated completion is 2027-04.

What conditions does trial NCT07226895 study?

This clinical trial studies the following conditions: Clinical High Risk for Psychosis (CHR). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07226895?

The interventions under investigation include: Placebo (DRUG), MT1988 Low Dose (DRUG), MT1988 High Dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07226895?

This trial is sponsored by Monument Therapeutics Limited, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07226895 being conducted?

This trial has 15 study locations across California, Connecticut, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial