{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T05:13:22Z","timestamp":1788585202429,"version":"build-2803163510"},"reference-count":31,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:00:00Z","timestamp":1761091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:00:00Z","timestamp":1761091200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2026,1]]},"abstract":"Abstract<\/jats:title>\n \n Aims<\/jats:title>\n \n Antipsychotics increase metabolic syndrome (\n MetSyn<\/jats:styled-content>\n ) and diabetes risk. Preclinical and translational research data suggest that ulotaront, an investigational trace amine\u2010associated receptor 1 (TAAR1) agonist, may have beneficial metabolic effects. This Phase 1b study collected pilot data on 4\u2010week ulotaront exposure and weight\u2010associated metabolic markers.\n <\/jats:p>\n <\/jats:sec>\n \n Materials and Methods<\/jats:title>\n \n A double\u2010blind, randomised, multiple\u2010dose within subject trial compared ulotaront to continued prior antipsychotic (\n PA<\/jats:styled-content>\n ) on metabolic markers in schizophrenia patients at high diabetes risk (presence of\n MetSyn<\/jats:styled-content>\n and prediabetes). Metabolic characteristics of patients at check\u2010in were compared to a matched historical cohort without schizophrenia or antipsychotic exposure.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n When compared to\n PA<\/jats:styled-content>\n , ulotaront treatment showed improvement trends for high glucose clamp, low glucose clamp, liver fat, liver fibro\u2010inflammation, back muscle fat infiltration, pancreas fat and pancreas volume. Visceral adipose tissue and weight changes favoured ulotaront treatment (\n p<\/jats:italic>\n \u2009<\u20090.001,\n p<\/jats:italic>\n \u2009=\u20090.047). Liver fibro\u2010inflammation distinguished antipsychotic\u2010induced metabolic changes from the historical cohort (\n p<\/jats:italic>\n \u2009=\u20090.002).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n 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\u2010induced weight\u2010associated markers. Liver fibro\u2010inflammation may serve as a potential marker for antipsychotic\u2010induced\n MetSyn<\/jats:styled-content>\n and prediabetes, and possible treatment target. Further research is needed to build on these findings.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.70110","type":"journal-article","created":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T03:46:00Z","timestamp":1761191160000},"page":"94-102","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A double\u2010blind study on ulotaront's impact on weight\u2010related parameters in schizophrenia patients with metabolic syndrome and prediabetes: Part\n II<\/scp>"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-7586-1583","authenticated-orcid":false,"given":"Snezana","family":"Milanovic","sequence":"first","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Lew","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kuangnan","family":"Xiong","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Casavant","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerard","family":"Galluppi","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu\u2010Luan","family":"Chen","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongquan","family":"Lai","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manu","family":"Chakravarthy","sequence":"additional","affiliation":[{"name":"Carmot Therapeutics Berkley California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clay","family":"Dehn","sequence":"additional","affiliation":[{"name":"Evolution Research Group Edison New Jersey USA"},{"name":"University of Jamestown Jamestown North Dakota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Jackson","sequence":"additional","affiliation":[{"name":"Perspectum Ltd. Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Koblan","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth C.","family":"Hopkins","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma America, Inc. Marlborough Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-021-01689-8"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.27.2.596"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph21040423"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.curtheres.2015.08.001"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0214921"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.molmet.2024.101883"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.15569"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.70136"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001779"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-048391"},{"key":"e_1_2_10_12_1","first-page":"220","article-title":"The pharmacodynamic effects of TAAR1 agonist ulotaront on metabolic biomarkers of glucose, c\u2010peptide, and insulin following a meal in patients with schizophrenia","volume":"47","author":"Milanovic S","year":"2022","journal-title":"Neuropsychopharmacology"},{"key":"e_1_2_10_13_1","unstructured":"CitromeL DworakH KoblanK et al.A randomized double\u2010blind active\u2010comparator\u2010controlled phase 3 study to evaluate the long\u2010term safety and tolerability of ulotaront in patients with schizophrenia. 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