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A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analog, on Food-related Behaviors in Patients With Prader-Willi Syndrome

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Trial Profile

A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analog, on Food-related Behaviors in Patients With Prader-Willi Syndrome

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 22 Nov 2019

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At a glance

  • Drugs Livoletide (Primary)
  • Indications Prader-Willi syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms ZEPHYR
  • Sponsors Millendo Therapeutics SAS

    • Most Recent Events

    • 13 Nov 2019 According to a Millendo Therapeutics media release, results from the Phase 2b portion of the study may be sufficient to support a new drug application (NDA) for livoletide.
    • 13 Nov 2019 According to a Millendo Therapeutics media release, the company continues to implement a protocol amendment globally adding an additional cohort of patients ages four to seven in the phase 2b part of the study.
    • 13 Nov 2019 According to a Millendo Therapeutics media release, enrolment in the phase 2b portion of the study has been completed for patients ages 8 to 65. More then 150 patients are enrolled in this cohort. Patient enrollment is ongoing in the separate cohort of patients ages 4 to 7.
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