Randomized, Double-Blind, Placebo-Controlled Phase II Trial of AYP-101 (Soybean Phosphatidylcholine) for Submental Fat Reduction in Asian Adults

Choi S. Y., HASSIBELNABY A. M. A., Kim B. J.

Clinical Therapeutics, cilt.47, sa.10, ss.889-893, 2025 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 47 Sayı: 10
  • Basım Tarihi: 2025
  • Doi Numarası: 10.1016/j.clinthera.2025.07.016
  • Dergi Adı: Clinical Therapeutics
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, PASCAL, BIOSIS, CAB Abstracts, CINAHL, EMBASE, International Pharmaceutical Abstracts, Veterinary Science Database
  • Sayfa Sayıları: ss.889-893
  • Anahtar Kelimeler: Lypolytic agents, Nonsurgical fat reduction, Soybean phosphatidylcholine, Submental fat
  • Atatürk Üniversitesi Adresli: Evet

Özet

Purpose: Submental fat (SMF) accumulation can affect self-image and psychological well-being, leading to a demand for nonsurgical treatment. AYP-101, which contains soybean phosphatidylcholine (SPC), is under investigation for SMF reduction. This study aimed to compare 2 concentrations of AYP-101 to placebo injections to determine the optimal concentration and evaluate safety and efficacy in reducing moderate to severe SMF in an Asian population. Methods: This single-center, randomized, double-blind, placebo-controlled phase II trial enrolled 96 participants with moderate to severe SMF. Participants were randomly assigned to receive either a placebo or AYP-101 at either a low concentration (25 mg/mL) or a high concentration (50 mg/mL), administered every 2 weeks for up to 6 sessions. The primary endpoint was the proportion of participants achieving at least a 1-grade improvement in both the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and the Subject-Reported Submental Fat Rating Scale (SR-SMFRS) at 4 and 12 weeks after the final injection. Findings: At 4 weeks post-treatment, 69.70% of the low-concentration group and 48.39% of the high-concentration group exhibited improvement in the ER-SMFRS, compared to 22.58% in the placebo group. Significant differences were noted between the low-concentration and placebo groups (P = 0.0002), with similar results at 12 weeks. Implications: AYP-101, administered biweekly at a concentration of 25 mg/mL, appears to be a safe and effective nonsurgical option for reducing SMF in Asians.