Clinical Trial: Safety and Tolerability of PBI-4050 and Its Effects on the Biomarkers in Subjects With Alström Syndrome

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

Official Title: A Phase 2, Single-Arm, Open-Label Study to Evaluate the Safety and Tolerability of PBI-4050 and of Its Effects on the Inflammatory, Fibrosis, Diabetes and Obesity Biomarkers in Subjects With

Brief Summary: This is a Phase 2, single-centre, single-arm, open-label study of the safety, tolerability, and effects on biomarkers of PBI-4050 in subjects with Alström syndrome for a treatment duration of 24 weeks.

Detailed Summary: This is a Phase 2, single-centre, single-arm, open-label study of the safety, tolerability, and effects on biomarkers of PBI-4050 in subjects with Alström syndrome. Approximately 18 subjects will be enrolled. The duration of study participation is approximately 34 weeks for each subject and comprises of 9 on site visits and telephone contacts in between visits.
Sponsor: ProMetic BioSciences Inc.

Current Primary Outcome: Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in fasting plasma glucose over time [ Time Frame: 24 weeks ]
  • Change from baseline in plasma insulin over time [ Time Frame: 24 weeks ]
  • Change from baseline in glycated hemoglobin (HbA1c) over time [ Time Frame: Baseline, 12 weeks and 24 weeks ]
  • Change from baseline in blood glucose as measured by weekly 4 point profile [ Time Frame: 24 weeks ]
  • Change from baseline in blood glucose as measured by monthly 7 point profile [ Time Frame: 24 weeks ]
  • Change from baseline of antidiabetic treatment [ Time Frame: 28 weeks ]
    Dosing change, new medication added or treatment discontinuation
  • Change from baseline in biomarkers in blood and urine over time [ Time Frame: 24 weeks ]
    Percentage of reduction and/or increase of level of biomarkers


Original Secondary Outcome: Same as current

Information By: ProMetic BioSciences Inc.

Dates:
Date Received: February 25, 2016
Date Started: December 2015
Date Completion: March 2017
Last Updated: April 11, 2016
Last Verified: February 2016