A Study of Vurolenatide in Adult Patients with Short Bowel Syndrome.
A Phase 2 study of Vurolenatide in adult patients with SBS. Patients were planned to be dosed in four treatment groups with placebo and/or active Vurolenatide. The study is 13 weeks (3 weeks screening, 4 weeks SC study drug administration, and 6 weeks of follow up). Safety and efficacy will be analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
Vurolenatide - 50 mg biweekly SC administration, PBO alternate weeks
Vurolenatide - 100 mg biweekly SC administration, PBO alternate weeks
Vurolenatide - 50 mg weekly SC administration
Research Site
Gainesville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Boston, Massachusetts, United States
Research Site
Omaha, Nebraska, United States
24hr total stool output volume
The primary outcome measure is 24hr total stool output volume over the double-blind treatment period compared to baseline.
Time frame: 10 weeks (including 6 weeks follow up)
Assess the safety and tolerability of vurolenatide
Assessment of Adverse events - The frequency of spontaneously reported AEs will be assessed for each treatment group separately by System Organ Class and Preferred Term; and vital signs, physical examination results, clinical laboratory tests results will be evaluated.
Time frame: 10 weeks (including 6 weeks follow up)
To assess change from Baseline in Quality of Life
Change from baseline in Quality of Life as measured by the SF-36 instrument over the double-blind treatment period
Time frame: 10 weeks (including 6 weeks follow up)
To assess the change from baseline in Patient Global Impression
Change from baseline in patient reported global SBS improvement over the double-blind treatment period
Time frame: 10 weeks (including 6 weeks follow up)
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PBO - weekly SC administration
Research Site
Durham, North Carolina, United States
Research Site
Nashville, Tennessee, United States