Trial Outcomes & Findings for Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) (NCT NCT03690206)

Last Updated: 2025-07-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

106 participants

Primary outcome timeframe

24 weeks

Results posted on

2025-07-17

Participant Flow

This trial was conducted in (number of sites that randomized patients in parenthesis) Belgium (1), Denmark (2), France (2), Germany (5), the Netherlands (1), Poland (3), Canada (3), the US (7), and the UK (5).

Patients were diagnosed with SBS and required PS at least 3 days/week. They were willing to adhere to an individual pre-defined drinking menu during 48 h measurement periods and maintain a stable weight. The drinking menu and the PS volume and content were adjusted during an optimization phase following by a stabilization phase.

Participant milestones

Participant milestones
Measure	Glepaglutide SC Injections Twice Weekly Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly Intervention: Placebo Placebo: Placebo for glepaglutide
Overall Study STARTED	35	35	36
Overall Study COMPLETED	31	35	36
Overall Study NOT COMPLETED	4	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Glepaglutide SC Injections Twice Weekly Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly Intervention: Placebo Placebo: Placebo for glepaglutide
Overall Study Withdrawal by Subject	2	0	0
Overall Study ICF withdrawal	2	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	28 Participants n=7 Participants	30 Participants n=5 Participants	81 Participants n=4 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants
Age, Continuous	56.9 years STANDARD_DEVIATION 13.4 • n=5 Participants	54.0 years STANDARD_DEVIATION 12.0 • n=7 Participants	55.0 years STANDARD_DEVIATION 11.8 • n=5 Participants	55.0 years STANDARD_DEVIATION 12.4 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	49 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	33 Participants n=7 Participants	32 Participants n=5 Participants	95 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	89 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment Canada	1 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Netherlands	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Belgium	3 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	10 participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	13 participants n=7 Participants	6 participants n=5 Participants	23 participants n=4 Participants
Region of Enrollment Denmark	5 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment Poland	8 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants	27 participants n=4 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	9 participants n=4 Participants
Region of Enrollment France	5 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	9 participants n=4 Participants
Region of Enrollment Germany	3 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	12 participants n=4 Participants
BMI	23.57 kg/m^2 STANDARD_DEVIATION 3.35 • n=5 Participants	22.72 kg/m^2 STANDARD_DEVIATION 3.21 • n=7 Participants	23.54 kg/m^2 STANDARD_DEVIATION 3.57 • n=5 Participants	23.28 kg/m^2 STANDARD_DEVIATION 3.37 • n=4 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of trial drug (glepaglutide or placebo). All efficacy analyses were based on the FAS. Patients were included in the analyses as randomized.

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Change in Weekly Parenteral Support (PS) Volume	-5.13 L/week Interval -6.24 to -4.02	-3.76 L/week Interval -4.96 to -2.56	-2.85 L/week Interval -3.93 to -1.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Clinical Response in PS Volume	23 Participants	16 Participants	14 Participants

SECONDARY outcome

Timeframe: 24 weeks

Achieving 1 or more days per week off PS

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Days Off PS	18 Participants	12 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 and 24 weeks

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

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Clinical Response in PS Volume	19 Participants	15 Participants	13 Participants

SECONDARY outcome

Timeframe: 24 weeks

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

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Weaned Off PS	5 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Change in weekly energy content of PS from baseline

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=26 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=28 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=27 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Energy Content	-7360.6 kJ/week Interval -48521.0 to 130351.0	-3085.9 kJ/week Interval -56550.0 to 1423.0	-734.2 kJ/week Interval -46307.0 to 1670.0

SECONDARY outcome

Timeframe: 24 weeks

Change in number of days on PS per week from baseline

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=31 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Days on PS	-1.00 days/week Interval -5.0 to 0.0	0.00 days/week Interval -7.0 to 1.0	0.00 days/week Interval -4.0 to 0.0

SECONDARY outcome

Timeframe: 20 and 24 weeks

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

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Change in PS Volume Per Week	15 Participants	10 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Patient Global Impression of Change Scale (PGIC) PGIC improved	22 participants	27 participants	13 participants
Patient Global Impression of Change Scale (PGIC) PGIC much/very much improved	17 participants	11 participants	2 participants

SECONDARY outcome

Timeframe: 28 weeks

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

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Safety - Adverse Events All AEs	33 Participants	33 Participants	27 Participants
Safety - Adverse Events Serious adverse events	9 Participants	10 Participants	7 Participants
Safety - Adverse Events AE Severity: Severe	10 Participants	5 Participants	2 Participants
Safety - Adverse Events AE Severity: Moderate	15 Participants	18 Participants	14 Participants
Safety - Adverse Events AE Severity: Mild	28 Participants	32 Participants	24 Participants
Safety - Adverse Events Relationship: Related	27 Participants	26 Participants	14 Participants
Safety - Adverse Events Relationship: Unlikely related	18 Participants	16 Participants	9 Participants
Safety - Adverse Events Relationship: Not related	26 Participants	26 Participants	23 Participants
Safety - Adverse Events AEs leading to trial withdrarwal	2 Participants	0 Participants	0 Participants
Safety - Adverse Events AEs with action taken drug withdrawn	2 Participants	1 Participants	0 Participants
Safety - Adverse Events AEs with action taken drug interrupted	3 Participants	0 Participants	3 Participants
Safety - Adverse Events Outcome: Recovered/resolved	32 Participants	30 Participants	25 Participants
Safety - Adverse Events Outcome: Recovering/resolving	7 Participants	9 Participants	5 Participants
Safety - Adverse Events Outcome: Recovered/resolved with sequelae	1 Participants	1 Participants	0 Participants
Safety - Adverse Events Outcome: Not recovered/not resolved	17 Participants	14 Participants	9 Participants
Safety - Adverse Events Outcome: Fatal	0 Participants	0 Participants	0 Participants
Safety - Adverse Events Outcome: Unknown	1 Participants	0 Participants	0 Participants
Safety - Adverse Events Outcome: MIssing	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Number of Patients With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Population: At certain visits those data are missing for some patients.

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.

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Safety - Changes in Blood Pressure From Baseline Week 1 Systolic blood pressure	-2.8 mmHg Interval -7.6 to 2.0	0.3 mmHg Interval -4.1 to 4.7	-4.5 mmHg Interval -8.2 to -0.7
Safety - Changes in Blood Pressure From Baseline Week 2 Systolic blood pressure	1.0 mmHg Interval -3.2 to 5.1	-0.1 mmHg Interval -4.6 to 4.4	-2.7 mmHg Interval -6.4 to 1.0
Safety - Changes in Blood Pressure From Baseline Week 4 Systolic blood pressure	-1.7 mmHg Interval -6.5 to 3.1	-0.2 mmHg Interval -3.9 to 3.4	-0.3 mmHg Interval -4.6 to 3.9
Safety - Changes in Blood Pressure From Baseline Week 8 Systolic blood pressure	0.3 mmHg Interval -5.4 to 6.0	-1.5 mmHg Interval -5.9 to 2.9	-2.5 mmHg Interval -6.9 to 1.8
Safety - Changes in Blood Pressure From Baseline Week 12 Systolic blood pressure	-4.4 mmHg Interval -9.6 to 0.8	3.3 mmHg Interval -1.0 to 7.6	-0.4 mmHg Interval -5.0 to 4.1
Safety - Changes in Blood Pressure From Baseline Week 16 Systolic blood pressure	0.1 mmHg Interval -5.6 to 5.8	0.4 mmHg Interval -4.7 to 5.5	-1.1 mmHg Interval -6.3 to 4.1
Safety - Changes in Blood Pressure From Baseline Week 20 Systolic blood pressure	1.3 mmHg Interval -5.8 to 8.3	1.2 mmHg Interval -3.6 to 6.0	-1.0 mmHg Interval -6.2 to 4.3
Safety - Changes in Blood Pressure From Baseline Week 24 Systolic blood pressure	-1.0 mmHg Interval -6.2 to 4.1	-1.1 mmHg Interval -5.6 to 3.4	-5.9 mmHg Interval -11.0 to -0.8
Safety - Changes in Blood Pressure From Baseline Week 1 Diastolic blood pressure	0.4 mmHg Interval -2.3 to 3.0	0.5 mmHg Interval -2.6 to 3.5	-2.0 mmHg Interval -4.6 to 0.6
Safety - Changes in Blood Pressure From Baseline Week 2 Diastolic blood pressure	2.5 mmHg Interval 0.2 to 4.7	-0.7 mmHg Interval -3.1 to 1.7	-1.7 mmHg Interval -5.0 to 1.6
Safety - Changes in Blood Pressure From Baseline Week 4 Diastolic blood pressure	0.0 mmHg Interval -2.8 to 2.8	-0.2 mmHg Interval -2.5 to 2.8	-1.5 mmHg Interval -4.6 to 1.6
Safety - Changes in Blood Pressure From Baseline Week 8 Diastolic blood pressure	-0.5 mmHg Interval -3.3 to 2.3	1.9 mmHg Interval -1.3 to 5.0	-0.6 mmHg Interval -3.3 to 2.2
Safety - Changes in Blood Pressure From Baseline Week 12 Diastolic blood pressure	-2.8 mmHg Interval -6.7 to 1.2	2.0 mmHg Interval -1.0 to 5.1	0.9 mmHg Interval -1.8 to 3.6
Safety - Changes in Blood Pressure From Baseline Week 20 Diastolic blood pressure	2.1 mmHg Interval -1.5 to 5.7	-0.7 mmHg Interval -3.9 to 2.4	0.4 mmHg Interval -3.3 to 4.1
Safety - Changes in Blood Pressure From Baseline Week 24 Diastolic blood pressure	2.2 mmHg Interval -1.6 to 5.9	0.0 mmHg Interval -2.7 to 2.7	-0.9 mmHg Interval -3.8 to 2.1

SECONDARY outcome

Timeframe: 28 weeks

Population: At certain visits those data are missing for some patients.

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.

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Safety - Changes in Body Temperature From Baseline Week 1	0.0 degree C Interval -0.1 to 0.2	-0.0 degree C Interval -0.2 to 0.1	0.1 degree C Interval 0.0 to 0.2
Safety - Changes in Body Temperature From Baseline Week 2	0.1 degree C Interval 0.0 to 0.2	-0.0 degree C Interval -0.2 to 0.1	0.0 degree C Interval -0.1 to 0.1
Safety - Changes in Body Temperature From Baseline Week 4	-0.1 degree C Interval -0.2 to 0.1	-0.0 degree C Interval -0.2 to 0.1	0.1 degree C Interval -0.1 to 0.2
Safety - Changes in Body Temperature From Baseline Week 8	0.0 degree C Interval -0.1 to 0.2	0.1 degree C Interval 0.0 to 0.2	-0.1 degree C Interval -0.2 to 0.1
Safety - Changes in Body Temperature From Baseline Week 12	-0.0 degree C Interval -0.2 to 0.1	-0.0 degree C Interval -0.1 to 0.1	0.1 degree C Interval -0.1 to 0.2
Safety - Changes in Body Temperature From Baseline Week 16	-0.0 degree C Interval -0.1 to 0.1	-0.0 degree C Interval -0.1 to 0.1	0.0 degree C Interval -0.1 to 0.1
Safety - Changes in Body Temperature From Baseline Week 20	0.1 degree C Interval -0.1 to 0.2	0.0 degree C Interval -0.1 to 0.1	0.1 degree C Interval -0.1 to 0.2
Safety - Changes in Body Temperature From Baseline Week 24	-0.0 degree C Interval -0.1 to 0.1	0.1 degree C Interval 0.0 to 0.2	0.1 degree C Interval 0.0 to 0.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glepaglutide SC Injections Twice Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 Participants Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 Participants Intervention: Placebo Placebo: Placebo for glepaglutide
Immunogenicity - Occurrence of Anti-drug Antibodies ADA (Treatment-induced)	30 Participants	31 Participants	0 Participants
Immunogenicity - Occurrence of Anti-drug Antibodies M2 BAb (Treatment-induced)	28 Participants	29 Participants	0 Participants
Immunogenicity - Occurrence of Anti-drug Antibodies NAb M2 (Treatment-induced)	10 Participants	14 Participants	0 Participants
Immunogenicity - Occurrence of Anti-drug Antibodies GLP-2 CR (Treatment-induced)	6 Participants	11 Participants	0 Participants

Adverse Events

Glepaglutide SC Injections Twice Weekly

Serious events: 9 serious events

Other events: 30 other events

Deaths: 0 deaths

Glepaglutide SC Injections Once Weekly and Placebo Once Weekly

Serious events: 10 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo SC Injections Twice Weekly

Serious events: 7 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Head of clinical operations

Zealand Pharma A/S

Phone: +45 8877 3600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Glepaglutide SC Injections Twice Weekly n=35 participants at risk Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 participants at risk Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 participants at risk Intervention: Placebo Placebo: Placebo for glepaglutide
Injury, poisoning and procedural complications Stoma site haemorrhage	5.9% 1/17 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/20 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/21 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Acetabulum fracture	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Nervous system disorders Dizziness	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Blood and lymphatic system disorders Blood loss anaemia	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Blood and lymphatic system disorders Iron deficiency anaemia	2.9% 1/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Pyrexia	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Catheter site necrosis	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Immune system disorders Hypersensitivity	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Haemorrhoids	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Hepatobiliary disorders Cholecystitis	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Renal and urinary disorders Acute kidney injury	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Infections and infestations Device related sepsis	5.7% 2/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Infections and infestations Infection	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Infections and infestations Large intestine infection	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Infections and infestations Vascular device infection	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.6% 2/36 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Infections and infestations COVID-19	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Infections and infestations Gastrointestinal viral infection	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Product Issues Device breakage	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Product Issues Device malfunction	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Metabolism and nutrition disorders Metabolic acidosis	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).

Other adverse events
Measure	Glepaglutide SC Injections Twice Weekly n=35 participants at risk Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly n=35 participants at risk Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide	Placebo SC Injections Twice Weekly n=36 participants at risk Intervention: Placebo Placebo: Placebo for glepaglutide
Investigations Weight decreased	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.6% 2/36 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Investigations Aspartate aminotransferase increased	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Stoma site oedema	23.5% 4/17 • Number of events 4 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	10.0% 2/20 • Number of events 11 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/21 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Stoma complication	5.9% 1/17 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	10.0% 2/20 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/21 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Stomal hernia	5.9% 1/17 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/20 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/21 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Procedural pain	5.7% 2/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Fall	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Stoma site irritation	0.00% 0/17 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.0% 1/20 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/21 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Contusion	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/17 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.0% 1/20 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/21 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Injury, poisoning and procedural complications Stoma site reaction	0.00% 0/17 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.0% 1/20 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/21 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Nervous system disorders Headache	11.4% 4/35 • Number of events 5 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	8.6% 3/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	8.3% 3/36 • Number of events 7 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Nervous system disorders Dizziness	5.7% 2/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	8.6% 3/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Injection site reaction	25.7% 9/35 • Number of events 135 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	42.9% 15/35 • Number of events 116 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Injection site erythema	14.3% 5/35 • Number of events 6 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	17.1% 6/35 • Number of events 60 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Pyrexia	11.4% 4/35 • Number of events 4 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Fatigue	11.4% 4/35 • Number of events 4 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	11.4% 4/35 • Number of events 6 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Injection site pain	11.4% 4/35 • Number of events 31 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	8.6% 3/35 • Number of events 29 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Injection site induration	11.4% 4/35 • Number of events 44 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Oedema peripheral	11.4% 4/35 • Number of events 4 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.6% 2/36 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Injection site irritation	8.6% 3/35 • Number of events 13 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Feeling hot	5.7% 2/35 • Number of events 4 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Injection site rash	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Malaise	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Injection site pruritus	2.9% 1/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	11.4% 4/35 • Number of events 22 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Complication associated with device	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
General disorders Injection site swelling	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Blood and lymphatic system disorders Iron deficiency anaemia	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Nausea	20.0% 7/35 • Number of events 8 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	8.6% 3/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 8 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Abdominal pain	14.3% 5/35 • Number of events 8 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	17.1% 6/35 • Number of events 7 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.6% 2/36 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Vomiting	8.6% 3/35 • Number of events 5 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	17.1% 6/35 • Number of events 6 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Abdominal discomfort	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.6% 2/36 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Dry mouth	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Diarrhoea	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Abdominal distension	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/36 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	0.00% 0/35 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.6% 2/36 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Skin and subcutaneous tissue disorders Rash	2.9% 1/35 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	2.8% 1/36 • Number of events 1 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
Musculoskeletal and connective tissue disorders Muscle spasms	8.6% 3/35 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	5.7% 2/35 • Number of events 2 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).	8.3% 3/36 • Number of events 3 • All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks. Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption. For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).