Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)

Change in Weekly Parenteral Support (PS) Volume

Time frame · 24 weeks

Change in weekly PS volume from baseline to Week 24. Baseline actual weekly PS volume was defined as the actual PS volume derived from a valid 7-day period prior to visit 1 (Day 1), i.e. during the stabilization phase. The actual weekly PS volume at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 was derived as the actual weekly PS volume received during the valid 7-day period prior to the visit. The source for the derivation was the PS volumes recorded by the patients in the eDiary.

Clinical Response in PS Volume

Time frame · 20 and 24 weeks

Clinical response, defined as at least 20% reduction in actual weekly PS volume from baseline to both Weeks 20 and 24.

Days Off PS

Time frame · 24 weeks

Achieving 1 or more days per week off PS

Clinical Response in PS Volume

Time frame · 12 and 24 weeks

Reduction of at least 20 percent in PS volume from baseline to both 12 and 24 weeks.

Weaned Off PS

Time frame · 24 weeks

Reduction in weekly PS volume of 100 percent (weaned off)

Energy Content

Time frame · 24 weeks

Change in weekly energy content of PS from baseline

Days on PS

Time frame · 24 weeks

Change in number of days on PS per week from baseline

Change in PS Volume Per Week

Time frame · 20 and 24 weeks

Achieving reduction of at least 40 percent in PS volume from baseline to both 20 and 24 weeks

Patient Global Impression of Change Scale (PGIC)

Time frame · 24 weeks

Patient Global Impression of Change scale (PGIC) improvement at Weeks 4, 12, 20, and 24 PGIC improvement was defined as responding "Very Much Improved" or "Much Improved" on a 7-point Likert Scale. Improvement between each glepaglutide treatment regimen compared to placebo was tested by week, using the CMH test adjusted for the stratification factor. Improvement between each glepaglutide treatment regimen versus placebo was tested using collapsed categories of Improvement, No Change, and Worsening, where Improvement is defined as a response of "Very Much Improved" or "Much Improved" or "Minimally Improved", and No Change is defined as the response of "No Change", and Worsening is defined as a response of "Minimally Worse" or "Much Worse" or "Very Much Worse". Improvement using collapsed categories between each glepaglutide treatment regimen compared to placebo was tested by week using a Mantel-Haenszel chi-squared test for ordered categories.

Safety - Adverse Events

Time frame · 28 weeks

Incidence and type of Adverse Events over an average of 28 weeks (24 weeks treatment + 4 weeks follow up)

Number of Patients With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)

Time frame · 28 weeks

Number of patients with clinically significant changes in ECG will be reported. Monitored ECG parameters included heart rate (beats/min), PR interval (ms), PR interval Aggregate (ms), QRS duration aggregate (ms), QT interval aggregate (ms), QTcF interval aggregate (ms), and RR interval (ms), as well as the overall interpretation of each subject's ECG recorded as Normal, Abnormal Not Clinically Significant, or Abnormal Clinically Significant.