In adults 18 years old and older with obesity due to BBS
IMCIVREE helped reduce weight and hunger measure over 1 year
Actor portrayals
IMCIVREE helped adults 18 years and older reach steady and long-lasting reduction in weight measures
IMCIVREE was studied in two first-ever Phase 3 clinical trials that included children and adults with obesity due to BBS. In the year-long study of people aged 6 and older with obesity due to BBS, 15 adults aged 18 years and older were included. All adults in the clinical trial had to have a body mass index (BMI) of 30 or more.
People 6 years and older taking IMCIVREE saw an ~8% average reduction in BMI* over the course of 1 year.
*People taking IMCIVREE had general improvements in other areas. Blood pressure, lipids, and waist size improved with IMCIVREE. Due to a limited number of people studied and the lack of a control group in the study, these treatment effects could not be accurately measured.
IMCIVREE helped adults reach steady and long-lasting weight reduction
For adults, weight loss was steady and meaningful during the first year and continued over 2 years in a long-term extension trial.
†A clinically meaningful reduction is generally defined as a reduction of greater than or equal to 5% in BMI.
No change to diet or exercise:
In the clinical trial, people were not required to change their diet or exercise routine.
IMCIVREE reduced weight early and continuously over the course of 2 years of treatment.
IMCIVREE reduced body weight over the course of the 1-year clinical trial. At the end of the clinical trial for IMCIVREE, 19 people continued in the long-term study; 6 of these people were adults. People were assessed every 3 months until the end of the study (up to 5 years or study withdrawal).
At 14 weeks, people lost an average of 11 pounds
4%
average reductions in weight
At 1 year, people lost an average of 20 pounds
10%
average reductions in weight
At 2 years, people lost even more weight
15%
average reductions in weight
6 adults were part of the study at 24 months
Representative BMI chart for an adult with obesity due to BBS before and after IMCIVREE
The BMI chart here shows a representation of an adult female with obesity due to BBS and how IMCIVREE might help to lower her BMI after 1 and 2 years of treatment, based on results from the IMCIVREE clinical study. BMI at the start of IMCIVREE treatment and after 1 and 2 years with IMCIVREE are average values for adults 18 years and older in the Phase 3 trial.
IMCIVREE provided reduction in hunger scores early and continuously throughout treatment in people 12 years and older
The effect of IMCIVREE on reducing hunger was studied in 14 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 in people 12 years and older
A majority of people 12 years and older reported a reduction in hunger within weeks of starting 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.
– Person living with obesity due to BBS
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
Individual results may vary.
Quality of life, a measure of a person's day-to-day well-being, was evaluated in people with obesity due to BBS
As part of this study, people with BBS were asked to evaluate aspects of their quality of life. For adults 18 years and older, questions in the survey measured:
- Physical ability in daily activities
- Self-esteem
- Sexual life
- Feelings of distress in public
- Ability to perform at work
Higher survey scores indicated improvement to daily life. Lower scores indicated a decrease.
On average, people reported higher scores after 1 year of taking IMCIVREE.
Although general improvements were measured, the number of people was too limited to make clear conclusions. The trial was also not set up to determine whether these changes were because of IMCIVREE.
The impact of IMCIVREE
Learn more about the impact of IMCIVREE from healthcare providers and people on treatment.
Resources and support tailored to your journey
Rhythm InTune Patient Education Managers (PEMs)† offer personalized educational resources designed around your treatment journey. From providing disease education to helping you stay on track with treatment, your PEM is here to support you or your loved one.
†Patient Education Managers are employees of Rhythm Pharmaceuticals and do not provide medical care or advice. We encourage you to always speak to your healthcare providers regarding your medical care.
Use our Doctor Discussion Guide to start the conversation about treatment with IMCIVREE.
Learn about the possible side effects
of IMCIVREE.