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 ]
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