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A Phase 3 Multi-Center, One-Year, Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to <6 Years of Age With Rare Genetic Causes of Obesity

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Trial Profile

A Phase 3 Multi-Center, One-Year, Open-Label Study of Setmelanotide in Pediatric Patients Aged 2 to <6 Years of Age With Rare Genetic Causes of Obesity

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 May 2024

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At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Bardet-Biedl Syndrome; Obesity
  • Focus Registrational; Therapeutic Use
  • Acronyms VENTURE
  • Sponsors Rhythm
  • Most Recent Events

    • 12 May 2024 This trial has been Discontinued in Spain, according to European Clinical Trials Database record.
    • 07 May 2024 According to a Rhythm Pharmaceuticals media release, company expect to complete submission of a supplementary New Drug Application (sNDA) to the FDA seeking a label expansion for IMCIVREE to treat pediatric patients between 2 and younger than 6 years old in approved indications in the second quarter of 2024, with EMA approval for this pediatric expansion potentially in the fourth quarter of 2024.
    • 20 Apr 2024 This trial has been Discontinued in Netherlands, according to European Clinical Trials Database record.
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