Can a new drug combo tame the weight gain from a key schizophrenia medication?

NCT ID NCT06174116

Recruiting now Disease control Sponsor: University of Massachusetts, Worcester Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding lumateperone (Caplyta) to clozapine can reduce common side effects like weight gain and high blood sugar in people with schizophrenia or schizoaffective disorder. Fifty participants will take either lumateperone or a placebo for 12 weeks while continuing their regular clozapine. Researchers will track changes in body composition, blood sugar, and cholesterol.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: lumateperone (Caplyta)
What this could lead to: If it works, this could offer a way to manage weight gain and metabolic problems caused by clozapine, improving long-term health for people with schizophrenia.
What could go wrong: This is a small, early-phase study (50 people) testing a short-term effect. It may not show significant benefits, and results may not apply to everyone. Side effects of lumateperone are possible.

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Conditions

The condition(s) this trial relates to.

Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCHIZO AFFECTIVE DISORDER SCHIZOPHRENIA

Contacts and locations

Locations

UMass Chan Medical School
RECRUITING

Worcester, Massachusetts, 01655, United States

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