How did IMCIVREE help reduce measures of weight and hunger in the BBS trial?
IMCIVREE reduced BMI Z-scores in children over the course of the 1-year clinical trial*
A BMI Z-score was used to measure the reduction in BMI in children. BMI Z-scores are reliable measures of weight in children who are still growing because they take into account height, age, and gender.
of children had a meaningful reduction in BMI Z-score†
In the clinical trial, people were not required to change their diet or exercise routine.
*N=14. N is the number of people evaluated. Children were 6 to 17 years of age.
Actor portrayal.IMCIVREE is the first and only treatment to significantly reduce BMI Z-score in children with obesity and a clinical diagnosis of BBS
In a long-term study, children who continued taking IMCIVREE maintained reductions in BMI Z-scores‡
Some people chose to continue taking IMCIVREE in a separate long-term clinical trial. After they received 2 years of treatment, their results were analyzed.
of patients (N=12) at 2 years had a meaningful reduction in BMI Z-score†
- There was a 0.72 average reduction in BMI Z-score†
Children who continued IMCIVREE for 2 years maintained meaningful reductions in BMI Z-score
†A clinically meaningful reduction is generally defined as a reduction of greater than or equal to 0.2 in BMI Z-score.
‡Change in BMI Z-score could not be calculated for one 20-year-old person who was 17 years old at the beginning of the original trial.
IMCIVREE reduced the severity of obesity in children living with BBS
You may be more familiar with viewing a child's growth as a percentile on a chart from the doctor. These same charts can be used for BMI. This growth chart represents what a hypothetical child with BBS who started IMCIVREE at age 12§ may experience in BMI reduction after 1 and 2 years, based on results from the clinical trials.
- At the start of the 1-year clinical trial, average BMI was 145% of the 95th percentile
- At the end of the 1-year clinical trial, average BMI was 127% of the 95th percentile
- 17-percentage-point reduction
Figure modeled after Gulati AK, Kaplan DW, Daniels SR. Clinical tracking of severely obese children: a new growth chart. Pediatrics. 2012;130(6):1136-1140.
§Growth chart above is based on females 2 to 20 years of age and is for illustrative purposes only.
IMCIVREE showed early, significant, and continued weight reduction
Average reductions in weight over the course of the 1-year clinical trial*†
In the clinical trial, people were not required to change their diet or exercise routine.
*Adults were 18 years of age or older.
†14 weeks: n=10; 1 year: n=12.
In a long-term study, adults who continued taking IMCIVREE for a total of 2 years lost even more weight
Average reduction in weight at 2 years in the long-term study‡
At the end of a clinical trial for IMCIVREE, 19 people continued in a long-term study. 6 of these people were adults. People are being assessed every 3 months until the end of the study (up to 5 years or study withdrawal).
‡n=6.
IMCIVREE reduced the severity of obesity in adults living with BBS
This growth chart represents what a hypothetical adult with BBS§ who started IMCIVREE at 20 years of age may experience in BMI reduction after 1 and 2 years, based on results from the clinical trials||
Chart is for illustrative purposes only.
§Not an actual patient.
||Patients with data after 1 year of treatment.
IMCIVREE has mainly helped me lose and control my weight. I know I couldn't have done it without this medication.
— Adult patient enrolled in the IMCIVREE clinical trial
IMCIVREE reduced weight early and continuously over the course of 2 years of treatment
IMCIVREE provided reduction in hunger scores early and continuously throughout treatment
The effect of IMCIVREE on reducing hunger was studied in people 12 years and older living with BBS who could self-report their hunger.
- They completed a questionnaire every day for 1 year to determine changes in their hunger
- People scored their hunger on a daily basis using a scale from 0 to 10
IMCIVREE reduced the most severe feelings of hunger
A majority of people experienced a reduction in hunger score within 2 weeks of taking IMCIVREE
Before IMCIVREE, I didn’t realize how much time I spent focusing on food, and how much that was affecting my day-to-day and the other things I could be accomplishing.
— Kathryn, a person living with BBS
The change in Reed's hunger has cascaded into many positive life changes for all of us. There's less agitation and anxiety over hunger or family meals. This is simple normalcy for many families, but for us, they're moments I'll never take for granted.
— Kat, caregiver of a child living with BBS
He is no longer digging through the fridge or garbage, so we do not lock them anymore. He isn’t asking for food constantly between meals and snacks, and I sometimes find myself realizing it’s been a few hours and asking him if he’s ready for a snack.
— Rachel, caregiver of a child living with BBS
