Get to know IMCIVREE


IMCIVREE is a prescription medicine used to treat certain types of obesity caused by genetic changes in the brain.

IMCIVREE stomach and brain connection

While there are many of these conditions, IMCIVREE is approved to treat obesity due to:

POMC
deficiency

POMC stands for proopiomelanocortin

PCSK1
deficiency

PCSK1 stands for proprotein convertase subtilisin/kexin type 1

LEPR
deficiency

LEPR stands for leptin receptor

These conditions occur when both copies of the relevant gene (one inherited from the mother and one from the father) have a specific change, or variant.

For example:

A change in the POMC gene

(POMC deficiency)

A change in the PCSK1 gene

(PCSK1 deficiency)

A change in the LEPR gene

(LEPR deficiency)

SYMPTOMS

Severe obesity early in life

Severe obesity
early in life

Intense hunger

Intense hunger




In people with obesity due to POMC, PCSK1, or LEPR deficiency, these genetic changes affect how the brain controls feelings of hunger, which leads to weight gain.

A genetic test is required prior to starting IMCIVREE.

Genetic test

Before IMCIVREE can be used, the genetic test must show that the changes, or variants, are considered pathogenic, likely pathogenic, or uncertain.

IMCIVREE is not for use in people with the following conditions because it may not work:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing (benign or likely benign result).
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic conditions and general obesity.

It is not known if IMCIVREE is safe and effective in children under 6 years of age.



Speak to your healthcare provider for more information about genetic testing, or to find out more about these specific conditions.


How it works

In the brain, important "roads," called pathways, are responsible for carrying messages between the brain and the body.

One of these roads, called the MC4R pathway, signals to the body when to eat and when to stop eating, and helps regulate metabolism.

Certain genetic changes, including those in the POMC, PCSK1, and LEPR genes, can “block” this pathway, stopping these messages from getting through. This leads to severe obesity.

MC4R pathway impaired

IMCIVREE helps activate the areas in the brain that control appetite, feeling full, and metabolism to help lose weight and keep it off.

MC4R pathway

Clinical study results

IMCIVREE was evaluated in 2 studies of people 6 years and older:

STUDY 1

people with obesity due to
POMC or PCSK1
deficiency

10
participants

Results after
1 year

STUDY 2

people with obesity due to
LEPR
deficiency

11
participants

Results after
1 year

IN BOTH STUDIES

Adults had a body mass index (BMI) of 30 kg/m2 or more.

Children had weight in the 95th percentile or higher using growth chart assessments.


Study design

IMCIVREE was evaluated in 21 individuals (10 from Study 1 and 11 from Study 2) who completed at least 1 year of treatment.

There were 6 additional participants who had not yet completed 1 year of treatment when this information was collected. Their results were not included in efficacy information, but are included in safety information.

IMCIVREE clinical study

Both studies included a period of time taking IMCIVREE, followed by a withdrawal period lasting 8 weeks, which included 4 weeks of IMCIVREE followed by 4 weeks of no treatment. Neither the investigators nor the participants were aware of when the 4-week non-treatment time period was occurring.

After the withdrawal period, participants went on to receive up to 32 additional weeks of treatment with IMCIVREE.

Effect of IMCIVREE

In clinical studies, IMCIVREE reduced weight and hunger
for people with obesity due to POMC or PCSK1 deficiency

Weight
STUDY 1
people with obesity due to
POMC or PCSK1 deficiency
POMC PCSK1 Weight Data

8 out of 10 people lost at least 10% of
their body weight at 1 year




IMCIVREE POMC PCSK1 study weight chart

*Participants who experienced weight loss of 5 kg/11 lbs (or 5% if their starting weight was less than 100 kg/220 lbs) during the first 10 weeks.

Hunger
STUDY 1
people with obesity due to
POMC or PCSK1 deficiency
Decrease in hunger

After 1 year, participants (n=8)
experienced a decrease from 7.9 to 5.5
in the median daily hunger score.

Changes in hunger were evaluated using a questionnaire that was completed each day for 1 year, by participants who were 12 years of age or older. The questionnaire measured hunger using a score ranging from 0 (not hungry at all) to 10 (hungriest possible).

A median is the middle value of a set of data that have been put into numerical order. The median is the value that divides the data into two halves.

IMPACT OF STOPPING TREATMENT

Treatment was stopped for a period of time to see how it impacted weight and hunger.

Over this withdrawal period:

  • Weight increased; when the withdrawal period ended and treatment was restarted, weight loss continued
  • Hunger scores generally worsened; hunger scores improved once treatment was restarted

In clinical studies, IMCIVREE reduced weight and hunger for people with obesity due to LEPR deficiency

Weight
STUDY 2
people with obesity due to LEPR
deficiency
LEPR Weight Loss Data

5 out of 11 people lost at least 10% of their body weight at 1 year




LEPR Study Weight Chart

*Participants who experienced weight loss of 5 kg/11 lbs (or 5% if their starting weight was less than 100 kg/220 lbs) during the first 10 weeks.

Hunger
STUDY 2
people with obesity due to LEPR
deficiency
Reduce hunger

After 1 year, participants (n=8)
experienced a decrease from 7.0 to 4.4
in the median daily hunger score.

Changes in hunger were evaluated using
a questionnaire that was completed
each day for 1 year, by participants who
were 12 years of age or older. The
questionnaire measured hunger using a
score ranging from 0 (not hungry at all)
to 10 (hungriest possible). 

A median is the middle value of a set of data that have been put into numerical order. The median is the value that divides the data into two halves.

IMPACT OF STOPPING TREATMENT

Treatment was stopped for a period of time to
see how it impacted weight and hunger.

Over this withdrawal period:

  • Weight increased; when the withdrawal
    period ended and treatment was restarted,
    weight loss continued
  • Hunger scores generally worsened; hunger
    scores improved once treatment was restarted

A guide to treatment

This brochure provides helpful information about what to expect on treatment.

IMCIVREE beginning treatment
Download
IMCIVREE treatment

What to know before
starting treatment

Taking IMCIVREE
IMCIVREE treatment resources

Find answers to common questions

Resources & Support

Important Safety Information

Before using IMCIVREE, tell your healthcare provider about all your medical conditions, including if you:

  • have or have had areas of darkened skin, including skin discoloration (hyperpigmentation).
  • have or have had depression, or suicidal thoughts or behavior.
  • have kidney problems.

What is IMCIVREE?
IMCIVREE is a prescription medicine used in adults and children 6 years of age and older with the genetic