{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T10:35:05Z","timestamp":1787826905455,"version":"build-2784847793"},"reference-count":35,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,9,19]],"date-time":"2025-09-19T00:00:00Z","timestamp":1758240000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,9,19]],"date-time":"2025-09-19T00:00:00Z","timestamp":1758240000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    ALG\u2013055009 is an oral thyroid hormone receptor beta (THR\u2010\u03b2) agonist being evaluated for treating metabolic dysfunction\u2013associated steatohepatitis (MASH). This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALG\u2010055009 and bioavailability\/food effect. Part 1 was a single\u2013ascending dose study in healthy participants randomized to ALG\u2010055009 (0.1 to 4.0\u00a0mg) or placebo. Part 2 was a multiple\u2013ascending dose study in participants with mild hyperlipidemia randomized to ALG\u2010055009 (0.3 to 1.0\u00a0mg) or placebo once daily for 14 days. Part 3 was an open\u2013label study to determine relative bioavailability and food effect of 0.6\u00a0mg ALG\u2010055009 solution versus soft gelatin (softgel) capsule formulation. Among 78 participants, ALG\u2010055009 was well tolerated, and most adverse events were mild or moderate with no clinically meaningful safety issues. Transient reductions in thyroid hormone levels were observed with no clinical manifestation of hypo\/hyperthyroidism. Plasma ALG\u2010055009 exposure increased in a dose\u2013proportional manner with rapid absorption, low variability, accumulation ranging from 1.6\u20102.6\u2010fold, and t\n                    <jats:sub>1\/2<\/jats:sub>\n                    of 20 h. Relative bioavailability of the softgel capsule was 86% versus solution, with no food effect. Dose\u2013dependent decreases in atherogenic lipids and increases in sex hormone binding globulin were observed. These results support further development of ALG\u2010055009 for patients with MASH.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1606","type":"journal-article","created":{"date-parts":[[2025,9,19]],"date-time":"2025-09-19T14:46:23Z","timestamp":1758293183000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A multipart phase 1 study of the safety, pharmacodynamics and pharmacokinetics of ALG\u2010055009, a novel thyroid hormone receptor beta (THR\u2010\u03b2) agonist for metabolic dysfunction\u2010associated steatohepatitis (MASH), in healthy participants"],"prefix":"10.1002","volume":"15","author":[{"given":"Hakim","family":"Charfi","sequence":"first","affiliation":[{"name":"Biotrial Rennes  Rennes Cedex France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benedetta","family":"Massetto","sequence":"additional","affiliation":[{"name":"Clinical Development Aligos Therapeutics, Inc.  South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan","family":"Fitzgerald","sequence":"additional","affiliation":[{"name":"Clinical Development Aligos Therapeutics, Inc.  South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kha","family":"Le","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Aligos Therapeutics, Inc.  South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanley","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical Development Aligos Therapeutics, Inc.  South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ifong","family":"Kan\u2010Eng","sequence":"additional","affiliation":[{"name":"Clinical Operations Aligos Therapeutics, Inc.  South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meenakshi","family":"Venkatraman","sequence":"additional","affiliation":[{"name":"CMC Aligos Therapeutics, Inc.  South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naqvi","family":"Mohammad","sequence":"additional","affiliation":[{"name":"CMC Aligos Therapeutics, Inc.  South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Blatt","sequence":"additional","affiliation":[{"name":"Aligos Therapeutics, Inc.  South San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tse\u2010I","family":"Lin","sequence":"additional","affiliation":[{"name":"Clinical Development Aligos Therapeutics, Inc.  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