{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T19:49:59Z","timestamp":1792093799800,"version":"4.4.0"},"reference-count":31,"publisher":"The Endocrine Society","issue":"1","license":[{"start":{"date-parts":[[2024,6,3]],"date-time":"2024-06-03T00:00:00Z","timestamp":1717372800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Crinetics Pharmaceuticals, Inc"},{"name":"Crinetics Pharmaceuticals, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Paltusotine is a nonpeptide selective somatostatin receptor 2 agonist in development as once-daily oral treatment for acromegaly.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of paltusotine in the treatment of patients with acromegaly previously controlled with injected somatostatin receptor ligands (SRLs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This phase 3, randomized, double-blind, placebo-controlled trial enrolled adults with acromegaly who had IGF-I \u22641.0 times the upper limit of normal (\u00d7ULN) while receiving a stable dose of depot octreotide or lanreotide. Patients were switched from injected SRLs and randomized to receive paltusotine or placebo orally for 36 weeks. The primary endpoint was proportion of patients maintaining IGF-I \u22641.0\u00d7 ULN. Secondary endpoints were change in IGF-I level, change in Acromegaly Symptom Diary score, and maintenance of mean 5-sample GH &amp;lt;1.0 ng\/mL.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The primary endpoint was met: 83.3% (25\/30) of patients receiving paltusotine and 3.6% (1\/28) receiving placebo maintained IGF-I \u22641.0\u00d7 ULN (odds ratio, 126.53; 95% CI, 13.73-&amp;gt;999.99; P &amp;lt; .0001). Paltusotine was also superior to placebo for all secondary endpoints: mean (\u00b1 SE) change in IGF-I of 0.04 \u00b1 0.09\u00d7 ULN vs 0.83 \u00b1 0.1\u00d7 ULN (P &amp;lt; .0001); mean (\u00b1 SE) change in Acromegaly Symptom Diary score of \u22120.6 \u00b1 1.5 vs 4.6 \u00b1 1.6 (P = .02); mean GH maintained at &amp;lt;1.0 ng\/mL in 20\/23 (87.0%) vs 5\/18 (27.8%) patients (odds ratio, 16.61; 95% CI, 2.86-181.36; P = .0003). The most common adverse events were acromegaly symptoms and gastrointestinal effects characteristic of SRLs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Replacement of injected SRLs by once-daily oral paltusotine was effective in maintaining both biochemical and symptom control in patients with acromegaly and was well tolerated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgae385","type":"journal-article","created":{"date-parts":[[2024,5,31]],"date-time":"2024-05-31T20:07:55Z","timestamp":1717186075000},"page":"228-237","source":"Crossref","is-referenced-by-count":45,"title":["Acromegaly Disease Control Maintained After Switching From Injected Somatostatin Receptor Ligands to Oral Paltusotine"],"prefix":"10.1210","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9250-3558","authenticated-orcid":false,"given":"M\u00f4nica 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 ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Casagrande","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals, Inc. , San Diego, CA 92121 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian J","family":"Strasburger","sequence":"additional","affiliation":[{"name":"Department of Medicine for Endocrinology and Metabolic Disorders, Charit\u00e9 Universitaetsmedizin , Berlin 10117 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4681-6668","authenticated-orcid":false,"given":"Martin","family":"Bidlingmaier","sequence":"additional","affiliation":[{"name":"Neuroendocrine Research Group, Department of Internal Medicine, Ludwig-Maximilians University , Munich 80336 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter J","family":"Snyder","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Pennsylvania , Philadelphia, PA 19104 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirtha A","family":"Guitelman","sequence":"additional","affiliation":[{"name":"Divisi\u00f3n Endocrinolog\u00eda, Hospital Carlos G. Durand , Buenos Aires 1405 ,","place":["Argentina"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesar L","family":"Boguszewski","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Endocrine Division (SEMPR), University Hospital, Federal University of Paran\u00e1 , Curitiba 80030-110 ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Buchfelder","sequence":"additional","affiliation":[{"name":"Neurosurgery Department, University Hospital Erlangen , Erlangen 91054 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilan","family":"Shimon","sequence":"additional","affiliation":[{"name":"Rabin-Beilinson Medical Center, Institute of Endocrinology , Petach Tikva 4941492 ,","place":["Israel"]},{"name":"Faculty of Medical and Health Sciences, School of Medicine, Tel Aviv University , Tel Aviv 6997801 ,","place":["Israel"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9517-338X","authenticated-orcid":false,"given":"Gerald","family":"Raverot","sequence":"additional","affiliation":[{"name":"Endocrinology Department, Reference Center for Rare Pituitary Diseases HYPO, \u201cGroupement Hospitalier Est\u201d Hospices Civils de Lyon , Lyon Cedex 69002 ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikl\u00f3s","family":"T\u00f3th","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Oncology, Semmelweis University , Budapest 1083 ,","place":["Hungary"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emese","family":"Mez\u0151si","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of P\u00e9cs Medical School , P\u00e9cs 7624 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