{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T06:12:13Z","timestamp":1791267133119,"version":"4.1.0"},"reference-count":36,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,6,9]],"date-time":"2025-06-09T00:00:00Z","timestamp":1749427200000},"content-version":"vor","delay-in-days":8,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J cachexia sarcopenia muscle"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    In December 2024, the Society on Cachexia and Wasting Disorders (SCWD) hosted a Regulatory and Trial Update Workshop in Washington, D.C., bringing together experts from academia, industry, and the US Food and Drug Administration (FDA). This article summarizes key topics discussed during the meeting, including diagnostic challenges, emerging assessment methods, and trial endpoints. The D\n                    <jats:sub>3<\/jats:sub>\n                    \u2010creatine dilution technique was highlighted as a promising tool for evaluating muscle mass. Additionally, the workshop addressed variability in computed tomography\u2010based lumbar skeletal muscle index measurements, emphasizing sources of variation at the instrument, imaging, and reader levels, as well as biological and clinical fluctuations. Discussions also focused on clinical trial endpoints for sarcopenia, particularly validated physical performance measures such as the Short Physical Performance Battery (SPPB), habitual gait speed, stair\u2010climb tests, and the 6\u2010min walk test. Furthermore, novel therapeutic approaches were explored, including 20\u2010hydroxyecdysone, enobosarm, anamorelin, ponsegromab, and nutritional supplementation, alongside broader strategies targeting myostatin\u2010activin signalling inhibition and Akt pathway activation. During the meeting, it was made clear that from a regulatory treatment development standpoint, clinically meaningful changes in patient\u2010reported outcomes, physical function and\/or morbidity\/mortality need to be shown. If the latter is not an efficacy endpoint, safety needs to be documented. Given that the population that may be addressed in aging associated sarcopenia is vast, the safety requirement standards applied for studies may be equivalent to those of studies in type 2 diabetes mellitus. Some argued at the meeting that this would make study programs so large that from an economic standpoint only therapies that significantly impact on morbidity\/mortality outcomes have a chance to be considered commercially feasible for development.\n                  <\/jats:p>","DOI":"10.1002\/jcsm.13841","type":"journal-article","created":{"date-parts":[[2025,6,9]],"date-time":"2025-06-09T04:09:36Z","timestamp":1749442176000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Sarcopenia in Ageing and Chronic Illness: Trial Endpoints and Regulatory Issues"],"prefix":"10.1002","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9818-042X","authenticated-orcid":false,"given":"Stephan","family":"von Haehling","sequence":"first","affiliation":[{"name":"Department of Cardiology and Pneumology University of G\u00f6ttingen Medical Center  G\u00f6ttingen Germany"},{"name":"German Center for Cardiovascular Research (DZHK), Partner Site G\u00f6ttingen  G\u00f6ttingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henning\u00a0T.","family":"Langer","sequence":"additional","affiliation":[{"name":"Muscle Wasting Laboratory, Department for Geriatrics and Medical Gerontology Charit\u00e9 Universit\u00e4tsmedizin Berlin, Campus Benjamin Franklin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven\u00a0B.","family":"Heymsfield","sequence":"additional","affiliation":[{"name":"Metabolism and Body Composition Pennington Biomedical Research Center  Baton Rouge Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William\u00a0J.","family":"Evans","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences and Toxicology University of California Berkeley  Berkeley California USA"},{"name":"Division of Geriatrics Duke University Medical Center  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan\u00a0D.","family":"Anker","sequence":"additional","affiliation":[{"name":"Berlin Institute of Health\u2010Center for Regenerative Therapies (BCRT) Charit\u00e9\u2010 Universit\u00e4tsmedizin Berlin  Berlin Germany"},{"name":"Deutsches Herzzentrum der Charit\u00e9, Department of Cardiology (Campus Virchow) Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"},{"name":"German Centre for Cardiovascular Research (DZHK) partner site Berlin  Berlin 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