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Review

Setmelanotide

No authors listed
In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
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Review

Setmelanotide

No authors listed.
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Excerpt

Setmelanotide is a melanocortin 4 receptor agonist that is used for chronic weight management for adults and children with rare genetic forms obesity due to gene defects in the melanocortin pathway. Setmelanotide therapy has not been associated serum aminotransferase or bilirubin elevations or to instances of clinically apparent liver injury.

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References

    1. FDA. Integrated Review. 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213793Orig1s000M...(FDA Integrated review of the data on setmelanotide safety and efficacy submitted in support of the application for its approval as therapy of several rare genetic forms of obesity mentions that “Overall, no trends or clinically meaningful changes were observed in clinical laboratory assessments throughout the studies.”).
    1. Clément K, van den Akker E, Argente J, Bahm A, Chung WK, Connors H, De Waele K, et al.; Setmelanotide POMC and LEPR Phase 3 Trial Investigators. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials. Lancet Diabetes Endocrinol. 2020;8:960-970.(Among 21 patients with obesity due to POMC deficiency [n=10] or LEPR deficiency [n=11] treated with setmelanotide injections for 12 weeks, followed by an 8 week placebo controlled withdrawal, and then a 32 week open label extension period, most patients lost weight and 80% of POMC vs 45% of LEPR subjects lost more than 10% of body weight, while adverse events included injection site reactions in 100%, hyperpigmentation in 71%, and nausea in 43%, but only one subject discontinued therapy because of an adverse event [eosinophilia], ALT and AST levels tended to improve with the weight loss, and there were no serious hepatic adverse events). - PubMed
    1. Haws R, Brady S, Davis E, Fletty K, Yuan G, Gordon G, Stewart M, Yanovski J. Effect of setmelanotide, a melanocortin-4 receptor agonist, on obesity in Bardet-Biedl syndrome. Diabetes Obes Metab. 2020;22:2133-2140.(Among 8 adolescents and adults with obesity due to Bardet-Biedl syndrome treated with setmelanotide, weight loss averaged 9% at 3 months and 16% at 12 months, while side effects included injection site reactions, hyperpigmentation, nausea, and vomiting and there were no discontinuations for adverse events; no mention of ALT or hepatotoxicity). - PMC - PubMed
    1. Markham A. Setmelanotide: first approval. Drugs. 2021;81:397-403.(Review of the chemical structure, mechanism of action, history of development, pharmacology, clinical efficacy, and safety of setmelanotide shortly after its approval as therapy of genetic forms of obesity in the US, discusses the frequency of common side effects, but does not mention ALT elevations or hepatotoxicity). - PubMed
    1. Setmelanotide (Imcivree) for rare genetic forms of obesity. Med Lett Drugs Ther. 2021;63(1629):e3-e4.(Concise review of the mechanism of action, clinical efficacy, safety, and costs of setmelanotide shortly after its approval for use in the US, discusses common adverse events; no mention of ALT elevations or hepatotoxicity). - PubMed

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