IMCIVREE delivered early, significant, and sustained reduction in BMI Z-score1
BMI Z-score* reduction in patients <18 years of age1†
*A BMI Z-score was used to measure the reduction in BMI in children. A BMI Z-score is a reliable measure of weight in children who are still growing because it accounts for height, age, and gender.2
†Data shown include only patients who received 52 weeks of IMCIVREE at the time of the analysis. Population sizes ranged from 8 to 16, with n=14 at 52 weeks on active treatment. Error bars are the standard deviation (SD).1
‡A clinically significant reduction is generally considered a ≥0.2 reduction in BMI Z-score. A 0.2 reduction is comparable to weight loss of approximately 5%.3
§ATB=active treatment baseline (defined as last measurement before the first dose of IMCIVREE; ie, week 0 for IMCIVREE group and week 14 for placebo group).1
Clinically significant -0.8 mean change in BMI Z-score1
In patients <18 years of age with BBS during the 14-week placebo-controlled period,
IMCIVREE significantly reduced weight vs placebo1
Weight changes in pivotal and supplemental patients <18 years of age with BBS during the 14-week double-blind, placebo-controlled period1
*Supplemental patients were enrolled after the pivotal cohort had begun treatment. None of the supplemental patients had completed 52 weeks of IMCIVREE treatment at the time of data analysis.
PCPB=placebo-controlled period baseline.
Change in BMI Z-score from baseline in patients <18 years of age after 52 weeks (n=14)1
86%
achieved a clinically significant ≥0.2 reduction* in BMI Z-score1,2
- 100% of patients <12 years of age (n=3) achieved a clinically significant ≥0.2 reduction in BMI Z-score
*A clinically significant reduction is generally considered a ≥0.2 reduction in BMI Z-score. A 0.2 reduction is comparable to weight loss of approximately 5%.2
In patients <18 years of age with BBS during the 14-week placebo-controlled period,
IMCIVREE significantly reduced weight vs placebo1
Weight changes in pivotal and supplemental patients <18 years of age with BBS during the 14-week double-blind, placebo-controlled period1
*Supplemental patients were enrolled after the pivotal cohort had begun treatment. None of the supplemental patients had completed 52 weeks of IMCIVREE treatment at the time of data analysis.
PCPB=placebo-controlled period baseline.
IMCIVREE significantly reduced the severity of obesity due to BBS1
This chart is a visual representation of what a female child with BBS* who started IMCIVREE at 12 years of age may experience in BMI reduction after 52 weeks, based on data from the phase 3 trial.1-5
*Not an actual patient.
Growth chart is based on females 2 to 20 years of age and is for illustrative purposes only.
In patients <18 years of age with BBS during the 14-week placebo-controlled period,
IMCIVREE significantly reduced weight vs placebo1
Weight changes in pivotal and supplemental patients <18 years of age with BBS during the 14-week double-blind, placebo-controlled period1
*Supplemental patients were enrolled after the pivotal cohort had begun treatment. None of the supplemental patients had completed 52 weeks of IMCIVREE treatment at the time of data analysis.
PCPB=placebo-controlled period baseline.
