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Completed

NCT Number: NCT04991311

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

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.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glepaglutide

Drug

Glepaglutide will be delivered in a single-use autoinjector.

Other names: ZP1848

Primary outcomes

  1. Change in Absorption of Wet Weight/Fluids

    Time frame: 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 outcomes

  1. Change in Absorption of Energy

    Time frame: 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.

  2. Change in Absorption of Carbohydrates

    Time frame: 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.

  3. Change in Absorption of Lipids

    Time frame: 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.

  4. Change in Absorption of Proteins

    Time frame: 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.

  5. Change in Absorption of Sodium

    Time frame: 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.

  6. Change in Absorption of Potassium

    Time frame: 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.

  7. Change in Absorption of Calcium

    Time frame: 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.

  8. Change in Absorption of Magnesium

    Time frame: 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.

  9. Change in Weekly Parenteral Support (PS) Volume

    Time frame: 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.

  10. Change in Weekly PS Volume

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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

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

  21. Change in Weekly PS Magnesium

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

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

  22. Change in Weekly PS Magnesium

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

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

  23. Anti-glepaglutide Antibodies

    Time frame: Week 56

    Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56

  24. Reactivity to ZP1848

    Time frame: Week 56

    Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56. Anti-drug antibodies (ADA) positive samples were analyzed for reactivity to ZP1848.

  25. Cross-reactivity to Glucagon-like Peptide-2 (GLP-2)

    Time frame: Week 56

    Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56. ADA positive samples were analyzed for cross-reactivity to glucagon-like peptide-2 (GLP-2).

  26. Glepaglutide Neutralizing Antibodies

    Time frame: Week 56

    Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study title

A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (SBS)

Acronym: EASE SBS 4

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2021
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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