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However, the largest Phase IIb trial involving 536 subjects failed to demonstrate statistically significant weight loss compared to placebo at the primary 12-week endpoint, leading Metabolic Pharmaceuticals to terminate development in 2007

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Luspatercept was approved by the US Food and Drug Administration (FDA) after the MEDALIST trial, 40 a randomized, placebo-controlled, phase 3 clinical trial, demonstrated that patients with very low- to intermediate-risk MDS-RS or MDS/MPN-RS-T (myeloproliferative neoplasia with ring sideroblasts and thrombocytosis) achieved higher rates of transfusion independence when treated with luspatercept (38%) compared to placebo (13%)