Short Bowel Syndrome
Conditions
Brief 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.
Interventions
DRUGGlepaglutide
Glepaglutide will be delivered in a single-use autoinjector.
Sponsors
Zealand Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change in Weekly PS Volume | 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. |
| 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. |
| Change in Weekly PS Lipids | 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. |
| Change in Weekly PS Proteins | 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. |
| Change in Weekly PS Sodium | 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. |
| Change in Weekly PS Potassium | 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. |
| Change in Weekly PS Magnesium | 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. |
| Anti-glepaglutide Antibodies | Week 56 | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56 |
| Reactivity to ZP1848 | 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. |
| Cross-reactivity to Glucagon-like Peptide-2 (GLP-2) | 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). |
| Glepaglutide Neutralizing Antibodies | Week 56 | Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56 |
| Change in Weekly PS Carbohydrates | 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. |
Countries
Denmark
Participant flow
Recruitment details
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.
Pre-assignment details
A total of 12 patients were screened: 1 patient failed the screening, 1 patient was withdrawn before receiving investigational product.
Participants by arm
| Arm | Count |
|---|---|
| Once-weekly Glepaglutide All participants received 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)
Glepaglutide: Glepaglutide was delivered in a single-use autoinjector. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Once-weekly Glepaglutide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 54.6 years STANDARD_DEVIATION 15.85 |
| BMI | 24.1 kg/m^2 STANDARD_DEVIATION 2.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment Denmark | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 6 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Wet Weight/Fluids | 841.6 g/day | Standard Deviation 1839.1 |
| Week 24 Group | Change in Absorption of Wet Weight/Fluids | 1240.0 g/day | Standard Deviation 1529.74 |
Comparison: The participants in both comparison groups are the same.p-value: =0.058595% CI: [-17.6, 814.4]Paired t-test (2-sided, alpha=0.05)
Secondary
Anti-glepaglutide Antibodies
Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56
Time frame: Week 56
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Group - Week 0 | Anti-glepaglutide Antibodies | 9 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Calcium | 1.3 mmol/day | Standard Deviation 6.42 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Carbohydrates | 39.8 g/day | Standard Deviation 48.31 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Energy | 1037.7 kJ/day | Standard Deviation 1182.18 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Lipids | 10.5 g/day | Standard Deviation 26.56 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Magnesium | -2.2 mmol/day | Standard Deviation 5.06 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Potassium | 1.9 mmol/day | Standard Deviation 26.44 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Proteins | 1.0 g/day | Standard Deviation 1.65 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Absorption of Sodium | 28.0 mmol/day | Standard Deviation 83.64 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly Parenteral Support (PS) Volume | -4688.1 mL | Standard Deviation 3150.67 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Carbohydrates | -3547.1 kJ | Standard Deviation 6375.32 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Carbohydrates | -4914.8 kJ | Standard Deviation 2452.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Lipids | -260.3 kJ | Standard Deviation 1361.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Lipids | -42.2 kJ | Standard Deviation 1869.08 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Magnesium | -5.8 mmol | Standard Deviation 14.84 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Magnesium | 1.6 mmol | Standard Deviation 9.02 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Potassium | -35.6 mmol | Standard Deviation 73.88 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Potassium | -58.9 mmol | Standard Deviation 51.64 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Proteins | -879.3 kJ | Standard Deviation 1939.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Proteins | -1057.7 kJ | Standard Deviation 983.93 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Sodium | -475.7 mmol | Standard Deviation 506.37 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Sodium | -473.7 mmol | Standard Deviation 440.09 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline Group - Week 0 | Change in Weekly PS Volume | -5312.6 mL | Standard Deviation 5463.54 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Group - Week 0 | Cross-reactivity to Glucagon-like Peptide-2 (GLP-2) | 1 Participants |
Secondary
Glepaglutide Neutralizing Antibodies
Monitored throughout the trial at baseline (Week 0) and weeks 4, 12, 24, 52 and 56
Time frame: Week 56
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Group - Week 0 | Glepaglutide Neutralizing Antibodies | 8 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline Group - Week 0 | Reactivity to ZP1848 | 8 Participants |