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Significant improvements in weight and hunger for adults1

Weight Results

In patients 4 years and older

IMCIVREE delivered rapid, significant, and sustained weight loss1,2

142 patients participated in the Phase 3, double-blind, multicenter, placebo-controlled pivotal trial of IMCIVREE in acquired HO (IMCIVREE, n=94; placebo, n=48)1

Primary Endpoint: BMI Mean Percent Change From Baseline by Treatment Group (N=142)1*

Line graph comparing BMI mean percent change from baseline over 56 weeks in patients treated with IMCIVREE versus placebo, showing a substantial reduction in BMI with IMCIVREE and a slight increase with placebo

18.4% placebo-adjusted reduction in BMI

at 52 weeks on a therapeutic dose*

15.8% mean reduction for IMCIVREE vs 2.6% mean increase for placebo (p<0.0001)1

  • 18.8% placebo-adjusted reduction in BMI for patients 18 years and older (n=66; 16.6% mean reduction for IMCIVREE vs 2.2% mean increase for placebo)2
  • 18.2% placebo-adjusted reduction in BMI for patients 4 to <18 years old (n=76; 15.3% mean reduction for IMCIVREE vs 3.0% mean increase for placebo)2

*IMCIVREE=94; placebo=48. LSM difference (95% CI: −21.9, −14.9).

Tape measure icon

15.2-cm placebo-adjusted reduction in waist circumference, indicative of reduced adiposity2,3

  • Mean reduction of 12.0 cm in waist circumference for IMCIVREE vs mean increase of 3.2 cm for placebo at 52 weeks (N=142)†
  • Waist circumference is a validated surrogate marker for excess adiposity
  • This endpoint was not included in the statistical testing hierarchy and was not controlled for multiplicity

†IMCIVREE=94; placebo=48.

In patients 18 years and older

IMCIVREE improved weight trajectory and helped adult patients achieve a healthier weight class2

Representative Weight Trajectory for an Adult Patient With Acquired HO Before and After IMCIVREE2

Representative BMI trajectory for an adult patient with acquired hypothalamic obesity before and after starting IMCIVREE, showing a rise from overweight to severe obesity following a tumor or injury event, then a 16.6% reduction in BMI after 1 year of IMCIVREE treatment

16.6% mean reduction in BMI for IMCIVREE

vs 2.2% mean increase for placebo2

45% (17/38) of adult patients achieved a BMI <30 with IMCIVREE, below the threshold for obesity.2

This chart applies mean trial data to a representative BMI trajectory in acquired HO to show what a patient taking IMCIVREE may experience after 1 year. BMI at the start of IMCIVREE treatment and after 1 year with IMCIVREE reflect mean values for patients 18 years and older in the Phase 3 trial. This growth chart is for illustrative purposes only.2

Changes in Weight Classification for Patients ≥18 Years Old With IMCIVREE2‡

Green down arrow icon8%

8% (3/38) reduced by 3
weight classes

Green down arrow icon34%

34% (13/38) reduced by 2
weight classes

Green down arrow icon29%

29% (11/38) reduced by 1
weight class

Weight Classes Based on BMI (kg/m2)

Obesity class III: ≥40

Obesity class II: ≥35-<40

Obesity class I: ≥30-<35

Overweight: ≥25-<30

Healthy weight: <25

‡Baseline and observed Primary Timepoint values utilized for comparison. Seven IMCIVREE patients did not have an observed Primary Timepoint Value indicated and are not included in the analysis. Nine patients were in the same weight class between Baseline and the Primary Timepoint. Two patients increased a weight class.2

Hunger Results

In patients 12 years and older

IMCIVREE delivered significant hunger reduction1,2

Key Secondary Endpoint: Hunger Mean Change From Baseline by Treatment Group in Patients ≥12 Years (n=110)1§

Line graph comparing mean change in daily most hunger score over 56 weeks in patients 12 years and older treated with IMCIVREE versus placebo, showing a greater reduction in hunger with IMCIVREE

2.3-point mean reduction

in daily most hunger score for IMCIVREE

vs 1.4-point mean reduction for placebo (p=0.04).1||

§IMCIVREE=74; placebo=36. Patients 12 years and older who were able to self-report their hunger recorded their maximal hunger ("most hunger") each day on an 11-point scale from 0 ("not hungry at all") to 10 ("hungriest possible").

||LSM difference: −0.8 (95% CI: −1.62, −0.02).

Impact on symptoms of hyperphagia

Patients 12 years and older who were able to self-report were also administered the Symptoms of Hyperphagia questionnaire. Based on their responses, the Symptoms of Hyperphagia Composite Score decreased from baseline to 52 weeks.2

Formal validation has not been completed for the instrument used to measure symptoms of hyperphagia in the acquired HO population. This endpoint was not powered for formal testing or significance.

Additional efficacy measures for adult patients

Cardiometabolic icon

Cardiometabolic parameters

Data icon

Weight-related quality of life

I feel more in control. I feel like I’m making decisions, not just hunger that takes over. I feel like I can have meals and move on and not have it consume me.

– Adult patient on IMCIVREE

Now, I’m actually able to be involved with other good activities. It’s a beautiful thing in my life. I am able to be involved.

– Adult patient on IMCIVREE

Individual results may vary.

Get your patient started with IMCIVREE.

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See efficacy data for IMCIVREE in children.

See Efficacy for Ages 4 to <18

BL=baseline, BMI=body mass index, CI=confidence interval, cm=centimeter, HO=hypothalamic obesity, kg=kilogram, m=meter.

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity (HO).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Other types of obesity not related to acquired hypothalamic obesity or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity

Important Safety Information

Contraindications

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

Warnings and Precautions

Disturbance in Sexual Arousal: Spontaneous penile erections and increased frequency of penile erections in males have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Acute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and secondary adrenal insufficiency reported serious adverse reactions related to acute adrenal insufficiency in 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.

Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus: Patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.

Adverse Reactions

  • Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, nausea, vomiting, and headache

Use in Specific Populations

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Please see full Prescribing Information for additional Important Safety Information.

References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc., 2026. 2. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA. 3. Ross R, Neeland IJ, Yamashita S, et al. Waist circumference as a vital sign in clinical practice: a Consensus Statement from the IAS and ICCR Working Group on Visceral Obesity. Nat Rev Endocrinol. 2020;16(3):177-189. doi:10.1038/s41574-019-0310-7

Indication and Important Safety Information

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity (HO).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Other types of obesity not related to acquired hypothalamic obesity or other FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity

Important Safety Information

Contraindications

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

Warnings and Precautions

Disturbance in Sexual Arousal: Spontaneous penile erections and increased frequency of penile erections in males have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Acute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and secondary adrenal insufficiency reported serious adverse reactions related to acute adrenal insufficiency in 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.

Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus: Patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.

Adverse Reactions

  • Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, nausea, vomiting, and headache

Use in Specific Populations

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Please see full Prescribing Information for additional Important Safety Information.

References:1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc., 2026.2. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA.3. Ross R, Neeland IJ, Yamashita S, et al. Waist circumference as a vital sign in clinical practice: a Consensus Statement from the IAS and ICCR Working Group on Visceral Obesity. Nat Rev Endocrinol. 2020;16(3):177-189. doi:10.1038/s41574-019-0310-7
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