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

Summary

In a multicenter Phase III RCT of 325 Chinese adults with moderate-to-severe submental fat, MEI005 produced significantly greater clinician- and patient-rated improvements than placebo and achieved meaningful MRI-measured volume reductions. Adverse events were mostly mild to moderate, supporting a minimally invasive option for submental contouring.

Key Findings

• Simultaneous ≥2-grade improvement on CR-SMFRS and PR-SMFRS in 18.9% with MEI005 vs 1.8% with placebo (P < .001).
• MRI showed ≥10% submental fat volume reduction in 50% of MEI005 patients vs 15.2% of placebo (P < .001).
• Caliper-measured thickness reduced by 21.42% with MEI005 vs 6.32% with placebo (P < .001).
• Patient-reported psychological impact and satisfaction improved more with MEI005; adverse events were mostly mild to moderate.

Clinical Implications

MEI005 may offer a safe, minimally invasive alternative to liposuction for submental fat reduction, with objective efficacy and favorable tolerability. Clinicians should monitor for skin laxity and tailor treatment sessions to achieve combined clinician- and patient-rated improvements.

Limitations

• Follow-up focused on outcomes at 12 weeks posttreatment; longer-term durability and skin laxity effects remain to be established.
• Generalisability beyond Chinese adults is uncertain.

Future Directions

Evaluate long-term durability, optimal dosing schedules, and effects on skin laxity; conduct head-to-head comparisons with other nonsurgical modalities and assess broader populations.