A randomized, double‐blind, multi‐center, placebo‐controlled, phase 2 clinical trial to evaluate the efficacy and safety of DWJ211 in the treatment of moderate to severe submental fat
Dermatologic Therapy Feb 15, 2022
In this study, 1% DWJ211 dose (a newly developed lipolytic injectable) was proven to be beneficial for submental fat (SMF) reduction and demonstrated a tolerable safety profile. Therefore, 1% was chosen as the dose to be investigated in a phase 3 clinical trial.
This is a multi-center, double-blind, placebo-controlled study including 136 persons with moderate to severe SMF who were randomly assigned to injections of DWJ211 0.5%, DWJ211 1%, DWJ211 2% or placebo in the submental area, every 4 weeks, up to week 12.
In the placebo, DWJ211 0.5%, DWJ211 1%, and DWJ211 2% groups, ≥1-grade improvement on the physician-assisted SMF rating scales was achieved by 41.7%, 65.7%, 84.4%, and 72.7% of the patients, respectively, and ≥1-grade improvement on the subject-assisted SMF rating scales was achieved by 50.0%, 71.4%, 93.8%, and 81.8%, respectively.
In each of the treatment groups, adverse drug reactions (ADRs) were more common, relative to placebo, with injection site pain being the most common ADR.
Serious adverse events were not observed.
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