IMCIVREE was studied in the first-ever phase 3 clinical trial dedicated to obesity and hunger reduction in patients with BBS1
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The efficacy and safety of IMCIVREE for the reduction of weight and hunger in patients with BBS were studied in a phase 3 trial with a randomized, double-blind, placebo-controlled period1-3
The study enrolled patients ≥6 years of age with obesity and a clinical diagnosis of BBS. Adult patients had a BMI of ≥30 kg/m2 and pediatric patients had weight in the ≥97th percentile using growth chart assessments. To maintain the blind during period 1 (14-week placebo-controlled period), dose titration to a fixed dose of 3 mg given subcutaneously once daily was performed during the first 2 weeks of both period 1 and period 2 (52-week open-label period). Efficacy analyses were conducted in 44 patients at the end of period 1 (week 14, placebo-controlled data) and in 31 patients during the active-treatment period, defined as the period from randomization to week 52 in patients initially randomized to IMCIVREE, and from week 14 to week 66 in patients initially randomized to placebo. Analyses of the active-treatment period include patients who had either completed 52 weeks from the start of IMCIVREE treatment or discontinued the study early at the time of the prespecified data cutoff.2
Hypothetical growth chart for an adolescent with BBS
This chart is a visual representation of the projected BMI trajectory of a hypothetical female adolescent with BBS* over time1-3
Figure modeled after Gulati AK, Kaplan DW, Daniels SR. Clinical tracking of severely obese children: a new growth chart. Pediatrics. 2012 Dec;130(6):1136-1140.
*Not an actual patient. Growth chart is based on females 2 to 20 years of age and is for illustrative purposes only.
Other parameters1
- Supportive of IMCIVREE’s effect on weight loss, there were general numeric improvements in blood pressure, lipids, and waist circumference. However, because of the limited number of patients studied and the lack of a control group, the treatment effects on these parameters could not be accurately quantified