REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Injectable Drug
Derek H Jones1, Jean Carruthers, John H Joseph
1*Dermatology Division, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California; †Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, Canada; ‡Department of Head and Neck Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California; §Department ofDermatology, Howard University College of Medicine, Washington, DC; ‖Kythera Biopharmaceuticals, Inc., Westlake Village, California (now an affiliate of Allergan plc, Irvine, California); ¶Evidence Scientific Solutions, Philadelphia, Pennsylvania.
ATX-101, an injectable deoxycholic acid, significantly improved submental fat (SMF) reduction in a Phase 3 trial. The treatment demonstrated high efficacy and safety, with most side effects being mild and transient.
Area of Science:
- Aesthetics
- Dermatology
- Pharmacology
Background:
- ATX-101, an injectable formulation of deoxycholic acid, is an FDA-approved treatment for submental fat (SMF) reduction.
- Submental fat is a common aesthetic concern, impacting patient satisfaction and psychological well-being.
Purpose of the Study:
- To evaluate the efficacy and safety of ATX-101 for submental fat reduction.
- To report findings from the REFINE-1, a Phase 3, randomized, double-blind, placebo-controlled clinical trial.
Main Methods:
- The study enrolled subjects with moderate to severe submental fat who received either ATX-101 (2 mg/cm²) or a placebo.
- Coprimary outcomes included composite improvements in clinician- and subject-assessed SMF severity at 12 weeks post-treatment.
- Magnetic resonance imaging (MRI) assessed submental volume reduction, and patient-reported outcomes were collected.
Main Results:
- ATX-101 achieved significantly higher composite response rates (≥1-grade: 70.0% vs 18.6%; ≥2-grade: 13.4% vs 0%) compared to placebo (p < .001).
- MRI showed over 8 times more responders in the ATX-101 group (46.3% vs 5.3%; p < .001).
- ATX-101 treatment led to significant improvements in psychological impact and treatment satisfaction (p < .001).
Conclusions:
- ATX-101 is a safe and effective first-in-class injectable drug for submental fat reduction.
- The treatment offers a well-tolerated option with a favorable safety profile, including transient and mild adverse events.
