Type 2 & other diabetes

An open‐label study on ulotaront's effects on insulin‐glucose regulation in schizophrenia patients with metabolic syndrome and prediabetes: Part I

Diabetes Obes MetabPublished Phase 1b open-label clinical trial

Authors' conclusion

Despite limited sample size, primary endpoints favoured ulotaront over prior antipsychotics with respect to a reduction trend in glucose, c-peptide and insulin. The insulin response after a solid meal was nominally significant, suggesting that semi-chronic twice-a-day dosing of ulotaront might improve insulin dynamics in schizophrenia patients at high diabetes risk.

Study context

Population
Schizophrenia patients with metabolic syndrome and prediabetes
Comparison
Ulotaront twice daily vs baseline on prior antipsychotic treatment
Outcome
Glucose, c-peptide and insulin (primary endpoints), ulotaront vs prior antipsychotics
Methodological detailsmulti-dose, comparison with each participant's baseline on prior antipsychotic
  • Multi-dose
  • Comparison with each participant's baseline on prior antipsychotic

Main finding

As reported in the abstract

Mean change from baseline in AUCs (OGTT and MMTT) · up to 3 weeks
OGTT glucose AUC, mean change from baseline
−19.7 h × mg/dL
OGTT C-peptide AUC, mean change from baseline
−269 h × pg/mL
OGTT insulin AUC, mean change from baseline
−41.0 h × uIU/mL
Mixed meal tolerance test (MMTT) glucose AUC, mean change from baseline
−10.8 h × mg/dL
MMTT C-peptide AUC, mean change from baseline
−2860 h × pg/mL
MMTT insulin AUC, mean change from baseline
−132 h × mg/dL
Insulin response during MMTT reached nominal statistical significance
p = 0.021, effect size = −0.7

Further findings

Gastric emptying time (GEBT)

Mean change from baseline gastric emptying time
−0.60 min

Original publication

An open‐label study on ulotaront's effects on insulin‐glucose regulation in schizophrenia patients with metabolic syndrome and prediabetes: Part I. Diabetes Obes Metab. Published 22 October 2025. doi:10.1111/dom.70136

Composed by AI from the published abstract and checked against it. How Briefs are made →

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