{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T06:13:59Z","timestamp":1793513639120,"version":"4.5.0"},"reference-count":47,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T00:00:00Z","timestamp":1765152000000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J cachexia sarcopenia muscle"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The Society on Cachexia and Wasting Disorders (SCWD) convened a Regulatory and Trial Update Workshop in Washington, D.C., in December 2024, assembling experts from academic institutions, the pharmaceutical industry and the US Food and Drug Administration (FDA) for focused discussions. This article summarizes the latter half of the meeting, which primarily focused on novel anti\u2010obesity therapies based on incretin pathway alteration. Discussions highlighted the impact of glucagon\u2010like peptide\u20101 (GLP\u20101) receptor agonists or GLP\u20101\/glucose\u2010dependent insulinotropic polypeptide (i.e., GLP\u20101\/GIP) agonists on body composition and muscle health; the challenges of distinguishing \u2018true\u2019 skeletal muscle from fat\u2010free tissue; the impact of treatment discontinuation and weight regain; advances in imaging and quantitative assessment of lean body mass; as well as insights from emerging muscle\u2010preserving therapies (e.g., bimagrumab, pemvidutide and enobosarm). There are significant challenges in defining meaningful structural, functional and patient\u2010reported endpoints for the use of muscle\u2010\u2018protective\u2019 drug therapies in the context of weight loss therapies. These also involve significant regulatory considerations for future drug development and approval pathways, for instance related to the very large number of individuals that may be considered for these therapeutic approaches as well as from the potential long (or life\u2010long) duration of therapy considered with these drugs. Together, these discussions highlight the growing importance of integrating body composition and functional assessments in future clinical trials.<\/jats:p>","DOI":"10.1002\/jcsm.70147","type":"journal-article","created":{"date-parts":[[2025,12,9]],"date-time":"2025-12-09T07:27:26Z","timestamp":1765265246000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Muscle Loss in Obesity Therapy as a Therapeutic Target: Trial Design and Endpoints for Regulatory Discussions"],"prefix":"10.1002","volume":"16","author":[{"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 Lower Saxony  G\u00f6ttingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryosuke","family":"Sato","sequence":"additional","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 Lower Saxony  G\u00f6ttingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henning","family":"Langer","sequence":"additional","affiliation":[{"name":"Department of Geriatrics and Medical Gerontology, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin Corporate Member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad\u00a0Shahzeb","family":"Khan","sequence":"additional","affiliation":[{"name":"Baylor Scott and White Health\u2010The Heart Hospital  Plano Texas USA"},{"name":"Baylor Scott and White Research Institute  Dallas Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew\u00a0J.\u00a0S.","family":"Coats","sequence":"additional","affiliation":[{"name":"Heart Research Institute University of Sydney  Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","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":"Steven","family":"Heymsfield","sequence":"additional","affiliation":[{"name":"Pennington Biomedical Research Center Louisiana State University  Baton Rouge Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan\u00a0D.","family":"Anker","sequence":"additional","affiliation":[{"name":"Department of Cardiology (CVK) German Heart Center Charit\u00e9  Berlin Germany"},{"name":"German Centre for Cardiovascular Research (DZHK) Partner Site Berlin Charit\u00e9 Universit\u00e4tsmedizin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,8]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2032183"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciae384"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmet.2025.07.004"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.molmet.2024.101880"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11695\u2010020\u201005070\u20106"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1210\/jendso\/bvae164"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/oby.20448"},{"key":"e_1_2_8_9_1","unstructured":"Yahoo Finance. \u2018Veru Announces Successful FDA Meeting Providing Regulatory Clarity for Enobosarm for Muscle Preservation in Combination With GLP\u20101 RA for Greater Weight Loss in the Treatment of Obesity\u2019. 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