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CompletedNCT04991311EASE SBS 4Updated Nov 22, 2024Results posted

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

A Phase 3 interventional study of Glepaglutide in Short Bowel Syndrome, sponsored by Zealand Pharma. Completed at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Zealand Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Short Bowel Syndrome
03

In context

Short Bowel Syndrome

149 studies on the registry are indexed under Short Bowel Syndrome; 25 are open to participants now.

This study's enrollment of 12 is below the median of 20 across 100 interventional studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

Zealand Pharma is the lead sponsor of 43 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    once-weekly glepaglutide

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

    Drug: Glepaglutide

Interventions

  • DrugGlepaglutide

    Glepaglutide will be delivered in a single-use autoinjector.

    Also known as: ZP1848

06

What researchers measure

Primary outcomes

  1. Change in Absorption of Wet Weight/Fluids

    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.

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

Secondary outcomes

  1. Change in Absorption of Energy

    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.

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

  2. Change in Absorption of Carbohydrates

    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.

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

  3. Change in Absorption of Lipids

    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.

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

  4. Change in Absorption of Proteins

    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.

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

  5. Change in Absorption of Sodium

    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.

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

  6. Change in Absorption of Potassium

    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.

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

  7. Change in Absorption of Calcium

    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.

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

  8. Change in Absorption of Magnesium

    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.

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

  9. Change in Weekly Parenteral Support (PS) Volume

    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.

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

  10. Change in Weekly PS Volume

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

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

  11. Change in Weekly PS Carbohydrates

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

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

  12. Change in Weekly PS Carbohydrates

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

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

  13. Change in Weekly PS Lipids

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

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

  14. Change in Weekly PS Lipids

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

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

  15. Change in Weekly PS Proteins

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

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

  16. Change in Weekly PS Proteins

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

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

  17. Change in Weekly PS Sodium

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

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

  18. Change in Weekly PS Sodium

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

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

  19. Change in Weekly PS Potassium

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

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

  20. Change in Weekly PS Potassium

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

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

  21. Change in Weekly PS Magnesium

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

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

  22. Change in Weekly PS Magnesium

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

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

  23. Anti-glepaglutide Antibodies

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

    Time frame: Week 56

  24. Reactivity to ZP1848

    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.

    Time frame: Week 56

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

    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).

    Time frame: Week 56

  26. Glepaglutide Neutralizing Antibodies

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

    Time frame: Week 56

07

Results

Posted Nov 22, 2024

Participant flow

The trial was conducted at a single site in Denmark. The study was planned to enroll a minimum of 6 and a maximum of 16 patients with SBS intestinal failure (SBS-IF) or SBS intestinal insufficiency (SBS-II). First patient recruited was on 10 Aug 2021.

Participant flow — Overall Study
MilestoneOnce-weekly Glepaglutide
Started10
Completed9
Not completed1
Withdrew: Adverse event1

Outcome measures

PrimaryChange in Absorption of Wet Weight/Fluids

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · g/day
Change in Absorption of Wet Weight/Fluids
g/dayBaseline Group - Week 0Week 24 Group
Change in Absorption of Wet Weight/Fluids841.6 ± 1839.101240.0 ± 1529.74
Statistical analysis
  • Baseline Group - Week 0 vs Week 24 Group · Paired t-test (2-sided, alpha=0.05) · p = = 0.0585 · Mean difference (final values): 398.4 · 95% CI -17.6 to 814.4
SecondaryChange in Absorption of Energy

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · kJ/day
Change in Absorption of Energy
kJ/dayOnce-weekly Glepaglutide
Change in Absorption of Energy1037.7 ± 1182.18
SecondaryChange in Absorption of Carbohydrates

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · g/day
Change in Absorption of Carbohydrates
g/dayOnce-weekly Glepaglutide
Change in Absorption of Carbohydrates39.8 ± 48.31
SecondaryChange in Absorption of Lipids

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · g/day
Change in Absorption of Lipids
g/dayOnce-weekly Glepaglutide
Change in Absorption of Lipids10.5 ± 26.56
SecondaryChange in Absorption of Proteins

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · g/day
Change in Absorption of Proteins
g/dayOnce-weekly Glepaglutide
Change in Absorption of Proteins1.0 ± 1.65
SecondaryChange in Absorption of Sodium

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · mmol/day
Change in Absorption of Sodium
mmol/dayOnce-weekly Glepaglutide
Change in Absorption of Sodium28.0 ± 83.64
SecondaryChange in Absorption of Potassium

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · mmol/day
Change in Absorption of Potassium
mmol/dayOnce-weekly Glepaglutide
Change in Absorption of Potassium1.9 ± 26.44
SecondaryChange in Absorption of Calcium

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · mmol/day
Change in Absorption of Calcium
mmol/dayOnce-weekly Glepaglutide
Change in Absorption of Calcium1.3 ± 6.42
SecondaryChange in Absorption of Magnesium

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.

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · mmol/day
Change in Absorption of Magnesium
mmol/dayOnce-weekly Glepaglutide
Change in Absorption of Magnesium-2.2 ± 5.06
SecondaryChange in Weekly Parenteral Support (PS) Volume

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.

Time frame:
from Week 0 (baseline) to Week 12
Reported as:
Mean · mL
Change in Weekly Parenteral Support (PS) Volume
mLOnce-weekly Glepaglutide
Change in Weekly Parenteral Support (PS) Volume-4688.1 ± 3150.67
SecondaryChange in Weekly PS Volume

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

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · mL
Change in Weekly PS Volume
mLOnce-weekly Glepaglutide
Change in Weekly PS Volume-5312.6 ± 5463.54
SecondaryChange in Weekly PS Carbohydrates

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

Time frame:
from Week 0 (baseline) to Week 12
Reported as:
Mean · kJ
Change in Weekly PS Carbohydrates
kJOnce-weekly Glepaglutide
Change in Weekly PS Carbohydrates-3547.1 ± 6375.32
SecondaryChange in Weekly PS Carbohydrates

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

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · kJ
Change in Weekly PS Carbohydrates
kJOnce-weekly Glepaglutide
Change in Weekly PS Carbohydrates-4914.8 ± 2452.10
SecondaryChange in Weekly PS Lipids

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

Time frame:
from Week 0 (baseline) to Week 12
Reported as:
Mean · kJ
Change in Weekly PS Lipids
kJOnce-weekly Glepaglutide
Change in Weekly PS Lipids-260.3 ± 1361.60
SecondaryChange in Weekly PS Lipids

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

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · kJ
Change in Weekly PS Lipids
kJOnce-weekly Glepaglutide
Change in Weekly PS Lipids-42.2 ± 1869.08
SecondaryChange in Weekly PS Proteins

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

Time frame:
from Week 0 (baseline) to Week 12
Reported as:
Mean · kJ
Change in Weekly PS Proteins
kJOnce-weekly Glepaglutide
Change in Weekly PS Proteins-879.3 ± 1939.60
SecondaryChange in Weekly PS Proteins

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

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · kJ
Change in Weekly PS Proteins
kJOnce-weekly Glepaglutide
Change in Weekly PS Proteins-1057.7 ± 983.93
SecondaryChange in Weekly PS Sodium

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

Time frame:
from Week 0 (baseline) to Week 12
Reported as:
Mean · mmol
Change in Weekly PS Sodium
mmolOnce-weekly Glepaglutide
Change in Weekly PS Sodium-473.7 ± 440.09
SecondaryChange in Weekly PS Sodium

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

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · mmol
Change in Weekly PS Sodium
mmolOnce-weekly Glepaglutide
Change in Weekly PS Sodium-475.7 ± 506.37
SecondaryChange in Weekly PS Potassium

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

Time frame:
from Week 0 (baseline) to Week 12
Reported as:
Mean · mmol
Change in Weekly PS Potassium
mmolOnce-weekly Glepaglutide
Change in Weekly PS Potassium-35.6 ± 73.88
SecondaryChange in Weekly PS Potassium

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

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · mmol
Change in Weekly PS Potassium
mmolOnce-weekly Glepaglutide
Change in Weekly PS Potassium-58.9 ± 51.64
SecondaryChange in Weekly PS Magnesium

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

Time frame:
from Week 0 (baseline) to Week 12
Reported as:
Mean · mmol
Change in Weekly PS Magnesium
mmolOnce-weekly Glepaglutide
Change in Weekly PS Magnesium1.6 ± 9.02
SecondaryChange in Weekly PS Magnesium

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

Time frame:
from Week 0 (baseline) to Week 24
Reported as:
Mean · mmol
Change in Weekly PS Magnesium
mmolOnce-weekly Glepaglutide
Change in Weekly PS Magnesium-5.8 ± 14.84
SecondaryAnti-glepaglutide Antibodies

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

Time frame:
Week 56
Reported as:
Count of participants · Participants
Anti-glepaglutide Antibodies
ParticipantsOnce-weekly Glepaglutide
Anti-glepaglutide Antibodies9
SecondaryReactivity to ZP1848

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.

Time frame:
Week 56
Reported as:
Count of participants · Participants
Reactivity to ZP1848
ParticipantsOnce-weekly Glepaglutide
Reactivity to ZP18488
SecondaryCross-reactivity to Glucagon-like Peptide-2 (GLP-2)

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).

Time frame:
Week 56
Reported as:
Count of participants · Participants
Cross-reactivity to Glucagon-like Peptide-2 (GLP-2)
ParticipantsOnce-weekly Glepaglutide
Cross-reactivity to Glucagon-like Peptide-2 (GLP-2)1
SecondaryGlepaglutide Neutralizing Antibodies

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

Time frame:
Week 56
Reported as:
Count of participants · Participants
Glepaglutide Neutralizing Antibodies
ParticipantsOnce-weekly Glepaglutide
Glepaglutide Neutralizing Antibodies8

Adverse events

Collected over Safety data cover the period since the first administrated dose till Week 56.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Once-weekly Glepaglutide1/10 (10%)6/10 (60%)10/10 (100%)
Most frequent serious events
Most frequent serious events
EventOnce-weekly Glepaglutide
Device related sepsisInfections and infestations2/10
Urinary tract infectionInfections and infestations2/10
Metastatic neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/10
Stoma obstructionInjury, poisoning and procedural complications1/10
Altered state of consciousnessNervous system disorders1/10
Crohn's diseaseGastrointestinal disorders1/10
NauseaGastrointestinal disorders1/10
Pelvic fluid collectionGastrointestinal disorders1/10
Pulmonary massRespiratory, thoracic and mediastinal disorders1/10
Stoma site abscessInfections and infestations1/10
Most frequent other events
Showing 10 of 66
Most frequent other events
EventOnce-weekly Glepaglutide
Gastrointestinal stoma complicationInjury, poisoning and procedural complications8/10
Injection site painGeneral disorders7/10
Injection site reactionGeneral disorders5/10
Oedema peripheralGeneral disorders5/10
Weight decreasedInvestigations3/10
DizzinessNervous system disorders3/10
Injection site pruritusGeneral disorders3/10
Abdominal painGastrointestinal disorders3/10
DiarrhoeaGastrointestinal disorders3/10
DehydrationMetabolism and nutrition disorders3/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Once-weekly Glepaglutide
<=18 years0
Between 18 and 65 years7
>=65 years3
Age, Continuous
Age, Continuous(years)Once-weekly Glepaglutide
Mean54.6 ± 15.85
Sex: Female, Male
Sex: Female, Male(Participants)Once-weekly Glepaglutide
Female5
Male5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Once-weekly Glepaglutide
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White10
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Once-weekly Glepaglutide
Denmark10
BMI
BMI(kg/m^2)Once-weekly Glepaglutide
Mean24.1 ± 2.32
08

Study locations

1 site
  • Rigshospitalet
    Copenhagen, Denmark
09

References and documents

Study documents

  • Study protocol · Jul 2, 2021
  • Statistical analysis plan · Nov 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04991311
Lead sponsor
Zealand Pharma
Responsible party
Sponsor
First posted
Aug 5, 2021
Start date
Aug 10, 2021
Primary completion
Feb 2, 2023
Completion
Sep 5, 2023
Results posted
Nov 22, 2024
Last update
Nov 22, 2024

Study contacts

Zealand Pharma
study director · Zealand Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Short Bowel Syndrome→

Other studies from this sponsor

Zealand Pharma

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