{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T10:14:04Z","timestamp":1792836844746,"version":"4.5.0"},"reference-count":34,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,9,7]],"date-time":"2021-09-07T00:00:00Z","timestamp":1630972800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["aspenjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Parenter Enteral Nutr"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Treatment with glucagon\u2010like peptide\u20102 (GLP\u20102) analogs improve intestinal adaptation in patients with short bowel syndrome\u2013associated intestinal failure (SBS\u2010IF) and may reduce parenteral support requirements. Apraglutide is a novel, long\u2010acting GLP\u20102 analog designed for once\u2010weekly dosing. This trial investigated the safety and efficacy of apraglutide in patients with SBS\u2010IF.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this placebo\u2010controlled, double\u2010blind, randomized, crossover phase 2 trial, eight adults with SBS\u2010IF were treated with once\u2010weekly 5\u2010mg apraglutide doses and placebo for 4 weeks, followed by once\u2010weekly 10\u2010mg apraglutide doses for 4 weeks, with a washout period of 6\u201310 weeks between treatments. Safety was the primary end point. Secondary end points included changes from baseline in urine volume output compared with placebo, collected for 48 h before and after each treatment period.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Common treatment\u2010related adverse events (AEs) were mild to moderate and included polyuria, decreased stoma output, stoma complications, decreased thirst, and edema. No serious AEs were considered to be related to apraglutide treatment. The safety profile was comparable for the lower and higher doses. Treatment with once\u2010weekly 5\u2010 and 10\u2010mg apraglutide doses significantly increased urine volume output by an adjusted mean of 714 ml\/day (95% CI, 490\u2013939; <jats:italic>P<\/jats:italic> &lt; .05) and 795 ml\/day (95% CI, 195\u20131394; <jats:italic>P<\/jats:italic> &lt; .05), respectively, compared with placebo, with no significant differences between doses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Once\u2010weekly apraglutide was well tolerated at both tested doses and significantly increased urine volume output, providing evidence for increased intestinal fluid absorption. A phase 3 trial is underway in adults with SBS\u2010IF.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jpen.2223","type":"journal-article","created":{"date-parts":[[2021,7,20]],"date-time":"2021-07-20T09:04:52Z","timestamp":1626771892000},"page":"896-904","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":50,"title":["Apraglutide, a novel glucagon\u2010like peptide\u20102 analog, improves fluid absorption in patients with short bowel syndrome intestinal failure: Findings from a placebo\u2010controlled, randomized phase 2 trial"],"prefix":"10.1002","volume":"46","author":[{"given":"Johanna","family":"Eliasson","sequence":"first","affiliation":[{"name":"Department of Intestinal Failure and Liver Diseases Rigshospitalet, Copenhagen University Hospital  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark K.","family":"Hvistendahl","sequence":"additional","affiliation":[{"name":"Department of Intestinal 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