This is a randomized, double-blind, placebo-controlled Phase Ⅱ clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20401 for Injection in a population with moderate to severe contour elevation or over-fullness due to SMF accumulation.
Eligible subjects were randomized in a 1: 1: 1 ratio to CU-20401 low dose group (0.06 mg/dose), CU-20401 high dose group (0.08 mg/dose), or placebo group using the severity of baseline clinician-reported SMF accumulation (score 2 or 3) as a stratification factor, and received a single subcutaneous injection of this group in the submental fat region on D1; return to the hospital for efficacy assessment on D29, D57, D85 or at early withdrawal; return to the hospital for safety assessment on D1, D8, D15, D29, D57, D85 or early withdrawal; immunogenicity samples were collected on D1, D8, D15, D29, D57, D85, or at early withdrawal (the study design is shown in the figure below).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Reconstitute the product with 0.9% sodium chloride solution for injection, respectively, before use, for a single subcutaneous injection in the submental fat area.
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
change in both CR-SMFRS score and PR-SMFRS score at the same time
at least 1 point change in both clinician-reported Submental Fat Rating Scale (CR-SMFRS) score and subject-reported Submental Fat Rating Scale (PR-SMFRS) score 爱at the same time. CR-SMFRS score ,0=None,1=Minor,2=Moderate,3=Serious,4=very severe. PR-SMFRS score,0=None,1=very little,2=a little,3=a few,4=a lot
Time frame: Day 29
Proportion of subjects with at least 1 point change in CR-SMFRS score and PR-SMFRS score
Proportion of subjects with at least 1 point change in clinician-reported Submental Fat Rating Scale (CR-SMFRS) score and subject-reported Submental Fat Rating Scale (PR-SMFRS) score. CR-SMFRS score ,0=None,1=Minor,2=Moderate,3=Serious,4=very severe. PR-SMFRS score,0=None,1=very little,2=a little,3=a few,4=a lot
Time frame: Day 57/ Day 85
Proportion of subjects with at least 2 points change in CR-SMFRS score and PR-SMFRS score
Proportion of subjects with at least 2 points change in clinician-reported Submental Fat Rating Scale (CR-SMFRS) score and subject-reported Submental Fat Rating Scale (PR-SMFRS) score. CR-SMFRS score ,0=None,1=Minor,2=Moderate,3=Serious,4=very severe. PR-SMFRS score,0=None,1=very little,2=a little,3=a few,4=a lot
Time frame: Day 29/Day 57/Day 85
change from baseline in CR-SMFRS score
change from baseline in clinician-reported Submental Fat Rating Scale (CR-SMFRS) score,0=None,1=Minor,2=Moderate,3=Serious,4=very severe
Time frame: Day 29/Day 57/Day 85
change from baseline in PR-SMFRS score
change from baseline insubject-reported Submental Fat Rating Scale (PR-SMFRS) score. ,0=None,1=very little,2=a little,3=a few,4=a lot
Time frame: Day 29/Day 57/Day 85
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Change from baseline in the total score of PR-SMFIS
Change from baseline in the total score of Submental Fat Impact Scale (PR-SMFIS) ,1=euphoria in the subject's mood ,2=distress,3=cares about,4=embarrassed about,5= look old,6=look overweight
Time frame: Day 29/Day 57/Day 85
Proportion of subjects with at least a 10% reduction from baseline in submental fat volume using MRI
Proportion of subjects with at least a 10% reduction from baseline in submental fat volume using MRI
Time frame: Day 29/Day 85
MRI was used to examine the change from baseline in submental fat volume
MRI was used to examine the change from baseline in submental fat volume
Time frame: Day 29/Day 85
MRI was used to examine the change from baseline in submental fat thickness
MRI was used to examine the change from baseline in submental fat thickness
Time frame: Day 29/Day 85
Change from baseline in Submental Skin Relaxity Scale (SMSLG)
Change from baseline in SMSLG score,1=None,2=Minor,3=Moderate,4=Serious
Time frame: Day 85