ATX-101 for reduction of submental fat: A phase III randomized controlled trial

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Abstract

Background ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat. Objective We sought to evaluate the efficacy and safety of ATX-101. Methods In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging–based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes. Results Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site. Limitations Follow-up was limited to 44 weeks. Conclusion ATX-101 is an alternative treatment for SMF reduction.

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APA

Humphrey, S., Sykes, J., Kantor, J., Bertucci, V., Walker, P., Lee, D. R., … Beddingfield, F. C. (2016). ATX-101 for reduction of submental fat: A phase III randomized controlled trial. In Journal of the American Academy of Dermatology (Vol. 75, pp. 788-797.e7). Mosby Inc. https://doi.org/10.1016/j.jaad.2016.04.028

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