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

ABSTRACT:

Aims

Ulotaront is an investigational trace amine-associated receptor 1 (TAAR1) agonist demonstrated to slow gastric emptying in schizophrenia patients with metabolic syndrome (MetSyn) and prediabetes type 2. Here we evaluate the effects of ulotaront on glucose-insulin dynamics in schizophrenia patients with MetSyn and prediabetes.

Methods and methods

NCT05463770 was a Phase 1b clinical trial, with an open-label, multi-dose design comparing ulotaront's metabolic effects to each participant's baseline of prior antipsychotic treatment. Oral glucose tolerance test (oGTT), a mixed meal tolerance test (MMTT) and a spirulina breath test (GEBT) were conducted at a baseline of prior antipsychotic medication and repeated after up to 3 weeks of twice-a-day dosing of ulotaront.

Resul

SUBMITTER: Milanovic S 

PROVIDER: S-EPMC12673454 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature