What it means for a patient
- AYP-101 is an investigational injection for fat under the chin. It was tested in Asian adults at a single center.
- In this trial, the lower concentration improved fat ratings in more participants than the higher concentration.
- Treatment involved up to 6 sessions, 2 weeks apart.
- The abstract does not list side effects, so their type and rate are not stated.
- This is a phase II trial of 96 people designed to choose a concentration.
Why this paper matters
It reported phase II dose-finding results for a soybean phosphatidylcholine injection for submental fat in an Asian population. It identified 25 mg/mL as the concentration the authors favor.
Overview
Fat under the chin (submental fat) can affect self-image and psychological well-being, and many people want a nonsurgical treatment. AYP-101 contains soybean phosphatidylcholine and is under investigation for submental fat reduction. This single-center, randomized, double-blind, placebo-controlled phase II trial compared two concentrations of AYP-101 with placebo. Its aims were to find the best concentration and to assess safety and effectiveness in an Asian population.
Findings
- 96 participants with moderate to severe submental fat were enrolled.
- Groups: placebo, low concentration (25 mg/mL) or high concentration (50 mg/mL).
- Injections were given every 2 weeks for up to 6 sessions.
- Primary endpoint: at least a 1-grade improvement on both the evaluator scale (ER-SMFRS) and the subject scale (SR-SMFRS) at 4 and 12 weeks after the final injection.
- ER-SMFRS improvement at 4 weeks: 69.70% (low concentration), 48.39% (high concentration), 22.58% (placebo).
- Low concentration vs placebo: significant difference (P = 0.0002).
- Results at 12 weeks were similar.
- The authors conclude that 25 mg/mL given every 2 weeks appears safe and effective.
- The abstract gives no adverse event data.
Terms
- Submental fat (SMF): fat under the chin.
- AYP-101: an investigational injection that contains soybean phosphatidylcholine.
- Soybean phosphatidylcholine (SPC): a compound from soybeans, found in cell membranes, used in fat-reducing injections.
- Phase II trial: a mid-stage trial that tests dose and early effectiveness.
- Placebo: an inactive injection used for comparison.
- Double-blind: neither participants nor investigators know who received the drug.
- ER-SMFRS: the Evaluator-Reported Submental Fat Rating Scale.
- SR-SMFRS: the Subject-Reported Submental Fat Rating Scale.
- Biweekly: every 2 weeks.