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

[BACKGROUND] 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.

[OBJECTIVES] This study evaluated the efficacy and safety of MEI005, a deoxycholic acid-based injectable formulation, in reducing SMF in Chinese adults.

[METHODS] 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.

[RESULTS] 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.

[CONCLUSIONS] MEI005 effectively reduces SMF, offering a safe, minimally invasive option for Chinese adults.