A double‐blind study on ulotaront's impact on weight‐related parameters in schizophrenia patients with metabolic syndrome and prediabetes: Part II
Authors' conclusion
Despite the sample size constraints due to early study termination, all key endpoint trends and statistically significant differences favoured ulotaront over previous antipsychotics, lending support that ulotaront may improve antipsychotic-induced weight-associated markers. Liver fibro-inflammation may serve as a potential marker for antipsychotic-induced MetSyn and prediabetes, and possible treatment target. Further research is needed to build on these findings.
Study context
- Population
- Schizophrenia patients at high diabetes risk (metabolic syndrome (MetSyn) and prediabetes)
- Comparison
- Ulotaront vs continued prior antipsychotic
Methodological detailsPhase 1b, double-blind, multiple-dose within subject, pilot, early study termination
- Phase 1b
- Double-blind
- Multiple-dose within subject
- Pilot
- Early study termination
Primary result
As reported in the abstract
Weight-associated metabolic markers · 4 weeks
- Improvement trends with ulotaront vs prior antipsychotic (PA) for high and low glucose clamp, liver fat, liver fibro-inflammation, back muscle fat infiltration, pancreas fat and pancreas volume
- Ulotaront vs PA: P < 0.001
- Ulotaront vs PA: P = 0.047
Further findings
Liver fibro-inflammation at check-in vs matched historical cohort without schizophrenia or antipsychotic exposure
- Liver fibro-inflammation distinguished antipsychotic-induced metabolic changes from the historical cohort
- P = 0.002
- Matched historical cohort
Original publication
A double‐blind study on ulotaront's impact on weight‐related parameters in schizophrenia patients with metabolic syndrome and prediabetes: Part II. Diabetes Obes Metab. Published 22 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →