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A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

ConditionsHypothalamic ObesityMultiple Pituitary Hormone Deficiency Genetic FormSepto-Optic DysplasiaOptic Nerve HypoplasiaChildhood-onset Combined Pituitary Hormone DeficiencyPituitary Stalk Interruption Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4+
SponsorRhythm Pharmaceuticals, Inc.

About this trial

This is a sub-study of Study RM-493-040 (NCT05774756).

The goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dysplasia (SOD), or optic nerve hypoplasia (ONH), or Childhood-onset combined pituitary hormone deficiency (CPHD), or Pituitary Stalk Interruption Syndrome (PSIS) with at least one pituitary deficiency AND a body mass index (BMI) of ≥30 kg/m2 for patients ≥18 years of age, or BMI ≥95th percentile for age and sex for patients 4 to <18 years

Age 4 years and older

Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to <18 years of age

Agree to use a highly effective form of contraception throughout the study and for 90 days after the study

Disqualifiers

Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)

Weight loss >2% in the previous 3 months for patients aged ≥18 years or >2% reduction in BMI for patients aged 4 to <18 years

Bariatric surgery or procedure within last 2 years

Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior

Trial design

Design model

Parallel

Treatments tested in this trial

  • Setmelanotide

    Drug

    Solution for daily subcutaneous injection

  • Placebo

    Drug

    Placebo matched to setmelanotide for daily subcutaneous injection

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: SetemelanotideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean % change in BMI

Time frame
From Baseline after 26 weeks on a therapeutic regimen

Secondary outcomes

1

Proportion of patients with ≥5% reduction in BMI in adult patients (≥18 years of age) or a BMI Z-score reduction of ≥0.2 points in pediatric patients (<18 years of age)

Time frame
From Baseline after 26 weeks on a therapeutic regimen
2

Mean change in the weekly average of the daily most hunger score in patients ≥12 years old

Time frame
From Baseline after 26 weeks on a therapeutic regimen
3

Proportion of patients with a ≥2 point reduction in the weekly average of the daily most hunger score

Time frame
From Baseline after 26 weeks on a therapeutic regimen
4

Mean change in Symptoms of Hyperphagia total score

Time frame
From Baseline after 26 weeks on a therapeutic regimen

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhythm Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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