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Trial · Interventional

CompletedPhase 3Results postedRegistry data

The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

Short name EASE SBS 4

NCTNCT04991311 (opens ClinicalTrials.gov in a new tab)Other idZP1848-20060Other id2020-005194-27Other idU1111-1260-2961
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
12 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Denmark

Start
10 Aug 2021
Primary completion
2 Feb 2023
Completion
5 Sept 2023
First posted
5 Aug 2021
Last update posted
22 Nov 2024
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 3

    EASE SBS 4

    NCT04991311

    10 Aug 2021 to 5 Sept 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections. Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.

Interventions

  • GlepaglutideDrug

Arms1

  • Experimental

    once-weekly glepaglutide

    All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Absorption of Wet Weight/Fluids

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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 outcomes(20)

  1. Change in Absorption of Energy

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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.

  2. Change in Absorption of Carbohydrates

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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.

  3. Change in Absorption of Lipids

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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.

  4. Change in Absorption of Proteins

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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.

  5. Change in Absorption of Sodium

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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.

  6. Change in Absorption of Potassium

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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.

  7. Change in Absorption of Calcium

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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.

  8. Change in Absorption of Magnesium

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    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.

  9. Change in Weekly Parenteral Support (PS) Volume

    Time frame · from Week 0 (baseline) to Week 12

    Registry description

    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.

  10. Change in Weekly PS Volume

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  11. Change in Weekly PS Carbohydrates

    Time frame · from Week 0 (baseline) to Week 12

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  12. Change in Weekly PS Carbohydrates

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  13. Change in Weekly PS Lipids

    Time frame · from Week 0 (baseline) to Week 12

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  14. Change in Weekly PS Lipids

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  15. Change in Weekly PS Proteins

    Time frame · from Week 0 (baseline) to Week 12

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  16. Change in Weekly PS Proteins

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  17. Change in Weekly PS Sodium

    Time frame · from Week 0 (baseline) to Week 12

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  18. Change in Weekly PS Sodium

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  19. Change in Weekly PS Potassium

    Time frame · from Week 0 (baseline) to Week 12

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

  20. Change in Weekly PS Potassium

    Time frame · from Week 0 (baseline) to Week 24

    Registry description

    Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· from Week 0 (baseline) to Week 24

Change in Absorption of Wet Weight/Fluids

GroupValue (g/day)Spread
Baseline Group - Week 0841.61839.10
Week 24 Group1240.01529.74
Secondary and other outcome results(7)
Secondary outcomeMean· from Week 0 (baseline) to Week 24

Change in Absorption of Energy

GroupValue (kJ/day)Spread
Once-weekly Glepaglutide1037.71182.18
Secondary outcomeMean· from Week 0 (baseline) to Week 24

Change in Absorption of Carbohydrates

GroupValue (g/day)Spread
Once-weekly Glepaglutide39.848.31
Secondary outcomeMean· from Week 0 (baseline) to Week 24

Change in Absorption of Lipids

GroupValue (g/day)Spread
Once-weekly Glepaglutide10.526.56
Secondary outcomeMean· from Week 0 (baseline) to Week 24

Change in Absorption of Proteins

GroupValue (g/day)Spread
Once-weekly Glepaglutide1.01.65
Secondary outcomeMean· from Week 0 (baseline) to Week 24

Change in Absorption of Sodium

GroupValue (mmol/day)Spread
Once-weekly Glepaglutide28.083.64
Secondary outcomeMean· from Week 0 (baseline) to Week 24

Change in Absorption of Potassium

GroupValue (mmol/day)Spread
Once-weekly Glepaglutide1.926.44
Secondary outcomeMean· from Week 0 (baseline) to Week 24

Change in Absorption of Calcium

GroupValue (mmol/day)Spread
Once-weekly Glepaglutide1.36.42

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Once-weekly GlepaglutideAll participants received glepaglutide 10 mg once weekly for 52 weeks as injections under the skin (subcutaneous, s.c.) with a subsequent 4-week follow up period.1 / 106 / 1010 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Age greater than or equal to 18 years and less than or equal to 90 years at screening * Stable condition of SBS either with intestinal failure (SBS-IF) or intestinal insufficiency. For patients with SBS-IF, a stable condition is defined as less than 25 percent change in parenteral support (PS) volume or energy content for 4 weeks prior to screening. * Stable body weight (less than 5 percent change in weight in the 3 months prior to screening) * Wet weight of fecal excretion greater than or equal to 1500 grams per day demonstrated during a hospital stay prior to screening Exclusion Criteria: * More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to screening * Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial * Current bowel obstruction * Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease * Cardiac disease defined as: decompensated heart failure (New York Heart Association \[NYHA\] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening * Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years * Use of glucagon-like peptide-1 (GLP-1), GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to screening

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