Clinical Trial: Setmelanotide Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity

Brief Summary: The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight, hunger assessments and other factors in patients with rare genetic disorders of obesity, including POMC deficiency, LepR deficiency, Bardet-Biedl syndrome and Alström syndrome.

Detailed Summary:
Sponsor: Rhythm Pharmaceuticals, Inc.

Current Primary Outcome: Effect on weight loss [ Time Frame: 1 year ]

Measurement of the effect of RM-493 on weight loss.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 1 year ]
    Assessment of Adverse Events related to treatment
  • Effect on Body Fat Mass [ Time Frame: 1 year ]
    Assessment of body composition as measured by bioelectrical impedance (BIA) or Dual-energy x-ray absorptiometry (DXA).
  • Effect on Hunger [ Time Frame: 1 year ]
    Assessment of hunger using a Hunger Questionnaire.
  • Effects on insulin sensitivity [ Time Frame: 1 year ]
    Ratios and HOMA-IR assessments of oral glucose tolerance test (OGTT) and immune-reactive insulin (IRI) levels.
  • Effect on Waist Circumference [ Time Frame: 1 year ]
    Assessment of waist circumference.
  • Reversal of weight during the off treatment withdrawal phase [ Time Frame: 2 to 4 weeks ]
    Assessment of weight regain during the withdrawal phase


Original Secondary Outcome: Same as current

Information By: Rhythm Pharmaceuticals, Inc.

Dates:
Date Received: January 3, 2017
Date Started: January 2017
Date Completion: December 2018
Last Updated: April 14, 2017
Last Verified: April 2017