{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T19:49:47Z","timestamp":1792093787689,"version":"4.4.0"},"reference-count":46,"publisher":"The Endocrine Society","issue":"5","license":[{"start":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T00:00:00Z","timestamp":1668038400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Crinetics Pharmaceuticals"},{"name":"Crinetics Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,4,13]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Paltusotine is a once-daily, oral, nonpeptide small-molecule somatostatin receptor type 2 (SST2) agonist in clinical development for treatment of acromegaly.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This work aimed to evaluate change in insulin-like growth factor I (IGF-I) levels in patients switched from octreotide long-acting release or lanreotide depot monotherapy to paltusotine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A phase 2, open-label, prospective, multicenter, multinational, nonrandomized, single-arm exploratory study was conducted in which dosage uptitrations were performed in a double-blinded manner. At 26 global sites, patients with acromegaly switched to paltusotine from injected somatostatin receptor ligand (SRL)-based therapy. Patients received 13-week treatment with once-daily oral paltusotine (10-40 mg\/d). The primary end point was change from baseline to week 13 in IGF-I for patients who switched from long-acting octreotide or lanreotide depot monotherapy to paltusotine (group 1). All patients underwent a 4-week paltusotine washout at end of treatment period (wk 13-17). IGF-I, growth hormone (GH), patient-reported outcome, and safety data were collected.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Forty-seven patients enrolled. In group 1 (n = 25), IGF-I and GH showed no significant change between SRL baseline and end of paltusotine treatment at week 13 (median change in IGF-I = \u22120.03\u00d7upper limit of normal [ULN]; P = .6285; GH = \u22120.05 ng\/mL; P = .6285). IGF-I and GH rose significantly in the 4 weeks after withdrawing paltusotine (median change in IGF-I = 0.55\u00d7ULN; P &amp;lt; .0001 [median increase 39%]; GH = 0.72 ng\/mL; P &amp;lt; .0001 [109.1% increase]). No patients discontinued because of adverse events (AE); no treatment-related serious AEs were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>These results suggest once-daily oral paltusotine was effective in maintaining IGF-I values in patients with acromegaly who switched from injected SRLs. Paltusotine was well tolerated with a safety profile consistent with other SRLs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgac643","type":"journal-article","created":{"date-parts":[[2022,11,10]],"date-time":"2022-11-10T02:19:00Z","timestamp":1668046740000},"page":"e148-e159","source":"Crossref","is-referenced-by-count":42,"title":["ACROBAT Edge: Safety and Efficacy of Switching Injected SRLs to Oral Paltusotine in Patients With Acromegaly"],"prefix":"10.1210","volume":"108","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9250-3558","authenticated-orcid":false,"given":"Monica R","family":"Gadelha","sequence":"first","affiliation":[{"name":"Neuroendocrinology Research Center\/Endocrinology Division, Medical School and Hospital Universitario Clementino Fraga Filho, Universidade Federal do Rio de Janeiro , Rio de Janeiro, CEP 21941-913 , Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murray B","family":"Gordon","sequence":"additional","affiliation":[{"name":"Allegheny Neuroendocrinology Center, Division of Endocrinology, Allegheny General Hospital , Pittsburgh, Pennsylvania 15212 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirjana","family":"Doknic","sequence":"additional","affiliation":[{"name":"Neuroendocrine Department, Clinic for Endocrinology, Diabetes and Metabolic Diseases, University Clinical Center of Serbia; Faculty of Medicine, University of Belgrade , Belgrade 11000 , Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emese","family":"Mez\u0151si","sequence":"additional","affiliation":[{"name":"First Department of Internal Medicine, Faculty of Medicine , University of P\u00e9cs Medical School, P\u00e9cs 7624 , Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikl\u00f3s","family":"T\u00f3th","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Oncology, Faculty of Medicine , Semmelweis University, Budapest 1085 , Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harpal","family":"Randeva","sequence":"additional","affiliation":[{"name":"Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (WISDEM) , University Hospitals Coventry and Warwickshire NHS Trust, Coventry CV2 2DX , UK"},{"name":"Division of Biomedicine, Warwick Medical School, University of Warwick , Coventry CV4 7AL , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tonya","family":"Marmon","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals Inc , San Diego, California 92121 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theresa","family":"Jochelson","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals Inc , San Diego, California 92121 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa","family":"Luo","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals Inc , San Diego, California 92121 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Monahan","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals Inc , San Diego, California 92121 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajay","family":"Madan","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals Inc , San Diego, California 92121 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Ferrara-Cook","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals Inc , San Diego, California 92121 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R Scott","family":"Struthers","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals Inc 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