Trial · NCT03690206

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

NCT03690206, Phase 3, Completed, Zealand Pharma; results first posted 2024-10-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS). Trials, record NCT03690206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03690206

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
NCT number: NCT03690206
Status: Completed
Phases: Phase 3
Enrollment: 106 participants, actual
Lead sponsor: Zealand Pharma
Conditions: Short Bowel Syndrome
Interventions: glepaglutide, Placebo
First posted: 2018-10-01
Last updated: 2025-07-17
Results first posted: 2024-10-21

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Change in Weekly Parenteral Support (PS) Volume	24 weeks	Change in weekly PS volume from baseline to Week 24. Baseline actual weekly PS volume was defined as the actual PS volume derived from a valid 7-day period prior to visit 1 (Day 1), i.e. during the stabilization phase. The actual weekly PS volume at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 was derived as the actual weekly PS volume received during the valid 7-day period prior to the visit. The source for the derivation was the PS volumes recorded by the patients in the eDiary.
Secondary	Clinical Response in PS Volume	20 and 24 weeks	Clinical response, defined as at least 20% reduction in actual weekly PS volume from baseline to both Weeks 20 and 24.
Secondary	Days Off PS	24 weeks	Achieving 1 or more days per week off PS
Secondary	Clinical Response in PS Volume	12 and 24 weeks	Reduction of at least 20 percent in PS volume from baseline to both 12 and 24 weeks.
Secondary	Weaned Off PS	24 weeks	Reduction in weekly PS volume of 100 percent (weaned off)
Secondary	Energy Content	24 weeks	Change in weekly energy content of PS from baseline
Secondary	Days on PS	24 weeks	Change in number of days on PS per week from baseline
Secondary	Change in PS Volume Per Week	20 and 24 weeks	Achieving reduction of at least 40 percent in PS volume from baseline to both 20 and 24 weeks
Secondary	Patient Global Impression of Change Scale (PGIC)	24 weeks	Patient Global Impression of Change scale (PGIC) improvement at Weeks 4, 12, 20, and 24 PGIC improvement was defined as responding "Very Much Improved" or "Much Improved" on a 7-point Likert Scale. Improvement between each glepaglutide treatment regimen compared to placebo was tested by week, using the CMH test adjusted for the stratification factor. Improvement between each glepaglutide treatment regimen versus placebo was tested using collapsed categories of Improvement, No Change, and Worsening, where Improvement is defined as a response of "Very Much Improved" or "Much Improved" or "Minimally Improved", and No Change is defined as the response of "No Change", and Worsening is defined as a response of "Minimally Worse" or "Much Worse" or "Very Much Worse". Improvement using collapsed categories between each glepaglutide treatment regimen compared to placebo was tested by week using a Mantel-Haenszel chi-squared test for ordered categories.
Secondary	Safety - Adverse Events	28 weeks	Incidence and type of Adverse Events over an average of 28 weeks (24 weeks treatment + 4 weeks follow up)

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Weekly Parenteral Support (PS) Volume	24 weeks	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.	L/week	LEAST_SQUARES_MEAN
SECONDARY	Clinical Response in PS Volume	20 and 24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Days Off PS	24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Response in PS Volume	12 and 24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Weaned Off PS	24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Energy Content	24 weeks		kJ/week	MEDIAN
SECONDARY	Days on PS	24 weeks		days/week	MEDIAN
SECONDARY	Change in PS Volume Per Week	20 and 24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Patient Global Impression of Change Scale (PGIC)	24 weeks		participants	NUMBER
SECONDARY	Safety - Adverse Events	28 weeks		Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group168

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Weekly Parenteral Support (PS) Volume	Glepaglutide SC Injections Twice Weekly	-5.13	95% Confidence Interval -6.24 to -4.02	L/week
Change in Weekly Parenteral Support (PS) Volume	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	-3.76	95% Confidence Interval -4.96 to -2.56	L/week
Change in Weekly Parenteral Support (PS) Volume	Placebo SC Injections Twice Weekly	-2.85	95% Confidence Interval -3.93 to -1.77	L/week
Clinical Response in PS Volume	Glepaglutide SC Injections Twice Weekly	23		Participants
Clinical Response in PS Volume	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	16		Participants
Clinical Response in PS Volume	Placebo SC Injections Twice Weekly	14		Participants
Days Off PS	Glepaglutide SC Injections Twice Weekly	18		Participants
Days Off PS	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	12		Participants
Days Off PS	Placebo SC Injections Twice Weekly	7		Participants
Clinical Response in PS Volume	Glepaglutide SC Injections Twice Weekly	19		Participants

1 to 10 of 168Source ClinicalTrials.gov

See all 168 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Glepaglutide SC Injections Twice Weekly	35
Overall Study	STARTED	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	35
Overall Study	STARTED	Placebo SC Injections Twice Weekly	36
Overall Study	COMPLETED	Glepaglutide SC Injections Twice Weekly	31
Overall Study	COMPLETED	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	35
Overall Study	COMPLETED	Placebo SC Injections Twice Weekly	36
Overall Study	NOT COMPLETED	Glepaglutide SC Injections Twice Weekly	4
Overall Study	NOT COMPLETED	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	0
Overall Study	NOT COMPLETED	Placebo SC Injections Twice Weekly	0

Source ClinicalTrials.gov

Adverse events219

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Weight decreased	Investigations	Glepaglutide SC Injections Twice Weekly	2	35	2
other	Weight decreased	Investigations	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	1	35	1
other	Weight decreased	Investigations	Placebo SC Injections Twice Weekly	2	36	2
other	Aspartate aminotransferase increased	Investigations	Glepaglutide SC Injections Twice Weekly	2	35	2
other	Aspartate aminotransferase increased	Investigations	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	1	35	1
other	Aspartate aminotransferase increased	Investigations	Placebo SC Injections Twice Weekly	0	36	0
other	Stoma site oedema	Injury, poisoning and procedural complications	Glepaglutide SC Injections Twice Weekly	4	17	4
other	Stoma site oedema	Injury, poisoning and procedural complications	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	2	20	11
other	Stoma site oedema	Injury, poisoning and procedural complications	Placebo SC Injections Twice Weekly	0	21	0
other	Stoma complication	Injury, poisoning and procedural complications	Glepaglutide SC Injections Twice Weekly	1	17	1

1 to 10 of 219Source ClinicalTrials.gov

See all 219 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Glepaglutide SC Injections Twice Weekly	0	35
Total, all-cause mortality	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	0	35
Total, all-cause mortality	Placebo SC Injections Twice Weekly	0	36
Total, other adverse events	Glepaglutide SC Injections Twice Weekly	30	35
Total, other adverse events	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	31	35
Total, other adverse events	Placebo SC Injections Twice Weekly	25	36
Total, serious adverse events	Glepaglutide SC Injections Twice Weekly	9	35
Total, serious adverse events	Glepaglutide SC Injections Once Weekly and Placebo Once Weekly	10	35
Total, serious adverse events	Placebo SC Injections Twice Weekly	7	36

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39708985	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

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

Each source's terms

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

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

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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