{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T11:24:12Z","timestamp":1781609052011,"version":"3.54.5"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T00:00:00Z","timestamp":1741046400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Caliway Biopharmaceuticals"},{"name":"Tech Observer Asia Pacific Pte. Ltd"},{"name":"Caliway Biopharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To further evaluate the efficacy and safety of CBL-514 for abdominal subcutaneous fat reduction.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this single-blind, randomized, parallel-group, placebo-controlled Phase 2 trial, 76 participants were randomized (2:1) to receive up to 4 CBL-514 treatments (2\u2005mg\/cm2, maximum 600\u2005mg\/treatment) or placebo, administered subcutaneously to the abdomen every 4 weeks. Two follow-up visits were conducted at 4 and 8 weeks following final treatment. Changes in abdominal subcutaneous fat thickness and volume were measured by ultrasound. The primary endpoint was the proportion of participants with subcutaneous fat volume loss of \u2265150\u2005mL from baseline compared with placebo.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In the intention-to-treat population, a significantly higher proportion of CBL-514-treated participants achieved \u2265150\u2005mL subcutaneous fat volume reduction from baseline compared with placebo-treated participants at both follow-up visits. At 8 weeks post final treatment, 69.6% of CBL-514-treated participants lost \u2265150\u2005mL subcutaneous fat, compared with none in the placebo group (P &amp;lt; .001). Moreover, 60.9% of participants in the CBL-514 group further achieved the \u2265200\u2005mL subcutaneous fat loss threshold. Of the 28 participants in CBL-514 group (n = 50) who lost \u2265150\u2005mL subcutaneous fat, 42.9% (12\/28 participants) achieved this target after a single treatment. The most common treatment-emergent adverse events were injection site reactions and were of mild-to-moderate severity.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a noninvasive treatment, CBL-514 could be a new, promising alternative therapy for effective targeted subcutaneous fat reduction.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Level of Evidence: 2<\/jats:title>\n                  <jats:p\/>\n               <\/jats:sec>","DOI":"10.1093\/asj\/sjaf032","type":"journal-article","created":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T12:21:53Z","timestamp":1741004513000},"page":"611-620","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and Safety of CBL-514 Injection in Reducing Abdominal Subcutaneous Fat: A Randomized, Single-Blind, Placebo-Controlled Phase II 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