A Randomized, Double-Blind, Placebo-Controlled, Multicentered Study to Evaluate the Efficacy and Safety of MEI005 in Reducing Submental Fat in Chinese Adults.

Abstract

Submental fat (SMF) is a common aesthetic concern traditionally treated with liposuction. Nonsurgical alternatives, like injectable deoxycholic acid, are gaining popularity. However, no related products have been clinically approved in China. This study evaluated the efficacy and safety of MEI005, a deoxycholic acid-based injectable formulation, in reducing SMF in Chinese adults. This multicenter, randomized, double-blind, placebo-controlled Phase III trial included 325 Chinese adults with moderate-to-severe SMF. Participants received MEI005 or a placebo injection every 28 days for up to 6 sessions. Primary endpoints were ≥2-grade improvements in Clinician and Patient-Reported Submental Fat Rating Scales (CR-SMFRS and PR-SMFRS). Secondary endpoints included SMF volume reductions measured by MRI; patient-reported outcomes on the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) and Subject Self-Rating Scale (SSRS); and SMF thickness reductions measured by caliper. Adverse events (AEs), self-reports, clinical examinations, and checks for skin laxity were monitored. At 12 weeks posttreatment, 18.9% of MEI005 recipients demonstrated simultaneously ≥2-grade CR-SMFRS and PR-SMFRS improvement vs 1.8% for placebo (P < .001). Additionally, 68.9% of MEI005 group participants achieved simultaneously ≥1-grade improvement in CR-SMFRS and PR-SMFRS, compared with 21.6% of placebo (P < .001). MRI revealed ≥10% SMF volume reduction in 50% of MEI005 patients vs 15.2% of placebo (P < .001). Scores on the PR-SMFIS and SSRSs showed greater psychological improvement and satisfaction among MEI005 recipients. Vernier caliper measurements showed a 21.42% thickness reduction vs 6.32% (P < .001). AEs were mostly mild to moderate. MEI005 effectively reduces SMF, offering a safe, minimally invasive option for Chinese adults.