Trial · NCT04991311
The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
NCT04991311, Phase 3, Completed, Zealand Pharma; results first posted 2024-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome. Trials, record NCT04991311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04991311
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
- NCT number
- NCT04991311
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Zealand Pharma
- Conditions
- Short Bowel Syndrome
- Interventions
- Glepaglutide
- First posted
- 2021-08-05
- Last updated
- 2024-11-22
- Other registries' IDs
- eudract:2020-005194-27
- Results first posted
- 2024-11-22
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Absorption of Wet Weight/Fluids | from Week 0 (baseline) to Week 24 | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. |
| Secondary | Change in Absorption of Energy | from Week 0 (baseline) to Week 24 | Oral intake minus fecal excretion: measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. Energy absorption was measured by bomb calorimetry. |
| Secondary | Change in Absorption of Carbohydrates | from Week 0 (baseline) to Week 24 | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. |
| Secondary | Change in Absorption of Lipids | from Week 0 (baseline) to Week 24 | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. |
| Secondary | Change in Absorption of Proteins | from Week 0 (baseline) to Week 24 | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. |
| Secondary | Change in Absorption of Sodium | from Week 0 (baseline) to Week 24 | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. |
| Secondary | Change in Absorption of Potassium | from Week 0 (baseline) to Week 24 | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. |
| Secondary | Change in Absorption of Calcium | from Week 0 (baseline) to Week 24 | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. |
| Secondary | Change in Absorption of Magnesium | from Week 0 (baseline) to Week 24 | Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. |
| Secondary | Change in Weekly Parenteral Support (PS) Volume | from Week 0 (baseline) to Week 12 | Only for participants with Short Bowel Syndrome with Intestinal Failure (SBS-IF). PS use was recorded in patient diaries throughout the trial, including type and volume used. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Absorption of Wet Weight/Fluids | from Week 0 (baseline) to Week 24 | g/day | MEAN | |
| SECONDARY | Change in Absorption of Energy | from Week 0 (baseline) to Week 24 | kJ/day | MEAN | |
| SECONDARY | Change in Absorption of Carbohydrates | from Week 0 (baseline) to Week 24 | g/day | MEAN | |
| SECONDARY | Change in Absorption of Lipids | from Week 0 (baseline) to Week 24 | g/day | MEAN | |
| SECONDARY | Change in Absorption of Proteins | from Week 0 (baseline) to Week 24 | g/day | MEAN | |
| SECONDARY | Change in Absorption of Sodium | from Week 0 (baseline) to Week 24 | mmol/day | MEAN | |
| SECONDARY | Change in Absorption of Potassium | from Week 0 (baseline) to Week 24 | mmol/day | MEAN | |
| SECONDARY | Change in Absorption of Calcium | from Week 0 (baseline) to Week 24 | mmol/day | MEAN | |
| SECONDARY | Change in Absorption of Magnesium | from Week 0 (baseline) to Week 24 | mmol/day | MEAN | |
| SECONDARY | Change in Weekly Parenteral Support (PS) Volume | from Week 0 (baseline) to Week 12 | mL | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Absorption of Wet Weight/Fluids | Baseline Group - Week 0 | 841.6 | Standard Deviation 1839.10 | g/day | |
| Change in Absorption of Wet Weight/Fluids | Week 24 Group | 1240.0 | Standard Deviation 1529.74 | g/day | |
| Change in Absorption of Energy | Once-weekly Glepaglutide | 1037.7 | Standard Deviation 1182.18 | kJ/day | |
| Change in Absorption of Carbohydrates | Once-weekly Glepaglutide | 39.8 | Standard Deviation 48.31 | g/day | |
| Change in Absorption of Lipids | Once-weekly Glepaglutide | 10.5 | Standard Deviation 26.56 | g/day | |
| Change in Absorption of Proteins | Once-weekly Glepaglutide | 1.0 | Standard Deviation 1.65 | g/day | |
| Change in Absorption of Sodium | Once-weekly Glepaglutide | 28.0 | Standard Deviation 83.64 | mmol/day | |
| Change in Absorption of Potassium | Once-weekly Glepaglutide | 1.9 | Standard Deviation 26.44 | mmol/day | |
| Change in Absorption of Calcium | Once-weekly Glepaglutide | 1.3 | Standard Deviation 6.42 | mmol/day | |
| Change in Absorption of Magnesium | Once-weekly Glepaglutide | -2.2 | Standard Deviation 5.06 | mmol/day |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Once-weekly Glepaglutide | 10 | |
| Overall Study | COMPLETED | Once-weekly Glepaglutide | 9 | |
| Overall Study | NOT COMPLETED | Once-weekly Glepaglutide | 1 |
Source ClinicalTrials.gov
Adverse events76
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 | Once-weekly Glepaglutide | 3 | 10 | 3 |
| other | Gastrointestinal stoma output abnormal | Investigations | Once-weekly Glepaglutide | 2 | 10 | 2 |
| other | Urine output decreased | Investigations | Once-weekly Glepaglutide | 2 | 10 | 2 |
| other | Weight increased | Investigations | Once-weekly Glepaglutide | 2 | 10 | 2 |
| other | Blood alkaline phosphatase increased | Investigations | Once-weekly Glepaglutide | 1 | 10 | 1 |
| other | Blood creatinine increased | Investigations | Once-weekly Glepaglutide | 1 | 10 | 1 |
| other | Gastrointestinal stoma output increased | Investigations | Once-weekly Glepaglutide | 1 | 10 | 1 |
| other | Gastrointestinal stoma complication | Injury, poisoning and procedural complications | Once-weekly Glepaglutide | 8 | 10 | 10 |
| other | Fall | Injury, poisoning and procedural complications | Once-weekly Glepaglutide | 1 | 10 | 1 |
| other | Hot flush | Vascular disorders | Once-weekly Glepaglutide | 2 | 10 | 2 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Once-weekly Glepaglutide | 1 | 10 |
| Total, other adverse events | Once-weekly Glepaglutide | 10 | 10 |
| Total, serious adverse events | Once-weekly Glepaglutide | 6 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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.
GET https://conductscience.org/api/trials/v1/NCT04991311
GET https://conductscience.org/api/trials/v1/NCT04991311/registered?page=2