



Paediatric data
Sustained BMI Z-score reduction up to 52 weeks†
Studied as exploratory endpoints measured by improvements in physical function and psychosocial scores‡
Most frequent adverse events were hyperpigmentation disorders, injection site reactions, nausea, and headache§
*
IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children six years of age and above.1
†
After 52 weeks, 71% of those <18 years old reached a 0.3, or greater, reduction in BMI Z-score (mean 0.8)6
‡
All patients with baseline quality of life impairment experienced clinically meaningful (defined as total score change >4.4) improvement and reported improvements in physical function and psychosocial scores.7
§
The most frequent adverse reactions are hyperpigmentation disorders (56%), injection site reactions (45%), nausea (31%), and headache (20%).1

*
Mean percentage change in BMI Z-score in patients with Bardet-Biedl syndrome.
Error bars show the SD. Data shown by study visit do not include data imputed for patients who received less than 52 weeks of IMCIVREE at the time of analysis. Active treatment baseline is defined as the last measurement before the first dose of IMCIVREE (ie., week 0 for the IMCIVREE group and week 14 for the placebo group).
BMI Z-score absolute change in pivotal patients with Bardet-Biedl syndrome younger than 18 years (population size range 8-16; n=14 at 52 weeks on active treatment).
PCPB, placebo-controlled period baseline.

Hyperpigmentation disorders
56%
Injection site reactions
45%
Nausea
31%
Headache
20%
IMCIVREE is an MC4R agonist with some activity at the melanocortin 1 (MC1) receptors. Activation of MC1 leads to accumulation of melanin and increased skin pigmentation. This effect is reversible upon discontinuation of treatment1
Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new skin pigmentary lesions1
Changes in skin pigmentation or hair colour primarily occurred within the first month of treatment1
Injection site reactions, nausea, and vomiting most often occurred within the first month after starting treatment, and then decreased over time1

No serious treatment-related AEs were reported2
There was no treatment-related worsening of depression2
12 years and older data
Early hunger reduction from 14 weeks onwards†
Sustained weight reduction up to 52 weeks‡
Studied as exploratory endpoints across five domains (physical function, self-esteem, public distress, sex life and work)§
Most frequent adverse events were hyperpigmentation disorders, injection site reactions, nausea, and headache||
*
IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS), loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.1
†
After 14 weeks, IMCIVREE patients ≥12 years old had an average 14.4% (95% CI: 31.9%, −3.14%; p=0.051) greater reduction in the weekly average of the daily maximal hunger score and 12.2% (95% CI: 32.4%, −7.9%; p=0.1081) greater reduction in the weekly morning average hunger.6
‡
After 52 weeks, 32.3% (95% CI 16.7-51.4; p=0·0006) of those ≥12 years old reached at least a 10% reduction in body weight.6
§
62.5% of patients ≥18 years old with quality-of-life impairment experienced clinically meaningful improvement. Quality of life score significantly correlated with percent body weight (P=0.0037) and BMI (P=0.0098) changes.7
||
The most frequent adverse reactions are hyperpigmentation disorders (56%), injection site reactions (45%), nausea (31%), and headache (20%).1
47% achieved >10% reduction in body weight6
60% achieved >5% reduction in body weight at 52 weeks6

*
Error bars show the SD. Data shown by study visit do not include data imputed for patients who received less than 52 weeks of IMCIVREE at the time of analysis. Active treatment baseline is defined as the last measurement before the first dose of IMCIVREE (ie, week 0 for the IMCIVREE group and week 14 for the placebo group). Bodyweight percentage change in the exploratory cohort of patients with Bardet-Biedl syndrome aged ≥ 18 years old (population size range 7-15; n=12 at 52 weeks on active treatment).
After 14 weeks, IMCIVREE patients ≥12 years old had an average 14.4% (95% CI: 31.9%, −3.14%; p=0.051) greater reduction in the weekly average of the daily maximal hunger score and 12.2% (95% CI: 32.4%, −7.9%; p=0.1081) greater reduction in the weekly morning average hunger.6
57% of patients reached ≥25% in their hunger score after 52 weeks of treatment with IMCIVREE, with a mean percentage change in maximal hunger score of −30.5% (SD 26.5%; −45.7% to−15.2%; p=0.0004).6
71% reached the clinically meaningful reduction in daily maximal hunger score of at least 1 point and 43% reached a reduction of 2 points or higher.6

*
Grey bars indicate titration and re-titration periods. Hunger scores are reported in patients ≥12 years old without cognitive impairment. PCPB, placebo-controlled period baseline.

Hyperpigmentation disorders
56%
Injection site reactions
45%
Nausea
31%
Headache
20%
IMCIVREE is an MC4R agonist with some activity at the melanocortin 1 (MC1) receptors. Activation of MC1 leads to accumulation of melanin and increased skin pigmentation. This effect is reversible upon discontinuation of treatment1
Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new skin pigmentary lesions1
Changes in skin pigmentation or hair colour primarily occurred within the first month of treatment1
Injection site reactions, nausea, and vomiting most often occurred within the first month after starting treatment, and then decreased over time1

No serious treatment-related AEs were reported2
There was no treatment-related worsening of depression2
All adverse events should be reported. For medical information, to report an adverse event or product complaint please contact eu_medinfo@rhythmtx.com