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A Phase 3 Trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alstrom Syndrome (AS) Patients With Moderate to Severe Obesity

Trial Profile

A Phase 3 Trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alstrom Syndrome (AS) Patients With Moderate to Severe Obesity

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Setmelanotide (Primary)
  • Indications Obesity
  • Focus Registrational; Therapeutic Use
  • Sponsors Rhythm
  • Most Recent Events

    • 02 Nov 2023 According to a Rhythm Pharmaceuticals media release, based on results from this study the Canadian Agency for Drugs and Technologies in Health (CADTH) has recommended that IMCIVREE (setmelanotide) be reimbursed by CADTH-participating public drug plans, with conditions, for weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl syndrome (BBS).
    • 27 Mar 2023 According to a Rhythm media release, Interview based research on setmelanotide improved hyperphagia and reduced body weight and obsessive focus on food published in peer-reviewed journal Advances in Therapy. Company also announced publication of health state utilities study in hyperphagia.
    • 24 Mar 2023 Results of Patients with BBS or their caregivers who participated in NCT03013543 and NCT03746522; assessing impact of hyperphagia on the lives of patients , published in the Advances in Therapy
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