Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Change in Weekly Parenteral Support (PS) Volume	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.
Secondary	Clinical Response in PS Volume	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.
Secondary	Days Off PS	24 weeks	Achieving 1 or more days per week off PS
Secondary	Clinical Response in PS Volume	12 and 24 weeks	Reduction of at least 20 percent in PS volume from baseline to both 12 and 24 weeks.
Secondary	Weaned Off PS	24 weeks	Reduction in weekly PS volume of 100 percent (weaned off)
Secondary	Energy Content	24 weeks	Change in weekly energy content of PS from baseline
Secondary	Days on PS	24 weeks	Change in number of days on PS per week from baseline
Secondary	Change in PS Volume Per Week	20 and 24 weeks	Achieving reduction of at least 40 percent in PS volume from baseline to both 20 and 24 weeks
Secondary	Patient Global Impression of Change Scale (PGIC)	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.
Secondary	Safety - Adverse Events	28 weeks	Incidence and type of Adverse Events over an average of 28 weeks (24 weeks treatment + 4 weeks follow up)
Secondary	Number of Patients With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)	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.
Secondary	Safety - Changes in Blood Pressure From Baseline	Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24	Changes in blood pressure are reported at Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 The data collected data are of seated diastolic and systolic blood pressure (mmHg). During treatment phase visits, vital signs were collected before investigational product injection.
Secondary	Safety - Changes in Body Temperature From Baseline	28 weeks	Changes in body temperature are reported The body temperature (ºC or ºF) was measured according to the site's usual procedure. During treatment phase visits, vital signs were collected before investigational product injection.
Secondary	Immunogenicity - Occurrence of Anti-drug Antibodies	28 weeks	Occurrence of antibodies against glepaglutide The occurrence of glepaglutide-binding antibodies (ADA), M2 binding antibodies (M2 BAb), glepaglutide neutralizing antibodies (NAb) and GLP-2 cross-reacting antibodies (GLP-2 CR) was tested.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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