Trial reportDiabetes, obesity & metabolism2026
A double-blind study on ulotaront's impact on weight-related parameters in schizophrenia patients with metabolic syndrome and prediabetes: Part II.
Trial report in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- A double-blind study on ulotaront's impact on weight-related parameters in schizophrenia patients with metabolic syndrome and prediabetes: Part II.Diabetes, obesity & metabolism · 2026Trial
- The Economic Impact of Cumulative Metabolic Comorbidity Burden in Schizophrenia: A Claims-Based Analysis of Medical Costs in the United States.Neurology and therapy · 2026Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsAntipsychotics increase metabolic syndrome (MetSyn) and diabetes risk. Preclinical and translational research data suggest that ulotaront, an investigational trace amine-associated receptor 1 (TAAR1) agonist, may have beneficial metabolic effects. This Phase 1b study collected pilot data on 4-week ulotaront exposure and weight-associated metabolic markers. MATERIALS AND
methodsA double-blind, randomised, multiple-dose within subject trial compared ulotaront to continued prior antipsychotic (PA) on metabolic markers in schizophrenia patients at high diabetes risk (presence of MetSyn and prediabetes). Metabolic characteristics of patients at check-in were compared to a matched historical cohort without schizophrenia or antipsychotic exposure.
resultsWhen compared to PA, ulotaront treatment showed improvement trends for high glucose clamp, low glucose clamp, liver fat, liver fibro-inflammation, back muscle fat infiltration, pancreas fat and pancreas volume. Visceral adipose tissue and weight changes favoured ulotaront treatment (p < 0.001, p = 0.047). Liver fibro-inflammation distinguished antipsychotic-induced metabolic changes from the historical cohort (p = 0.002).
conclusionsDespite 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.
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