Trial Outcomes & Findings for The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (NCT NCT04991311)

NCT ID: NCT04991311

Last Updated: 2024-11-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: from Week 0 (baseline) to Week 24
• Results posted on: 2024-11-22

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.

A total of 12 patients were screened: 1 patient failed the screening, 1 patient was withdrawn before receiving investigational product.

Participant milestones

Measure	Once-weekly Glepaglutide All 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. Glepaglutide: Glepaglutide was delivered in a single-use autoinjector.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Once-weekly Glepaglutide All 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. Glepaglutide: Glepaglutide was delivered in a single-use autoinjector.
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Once-weekly Glepaglutide n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	54.6 years STANDARD_DEVIATION 15.85 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Denmark	10 participants n=5 Participants
BMI	24.1 kg/m^2 STANDARD_DEVIATION 2.32 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group n=10 Participants Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Wet Weight/Fluids	841.6 g/day Standard Deviation 1839.10	1240.0 g/day Standard Deviation 1529.74

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Energy	1037.7 kJ/day Standard Deviation 1182.18	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Carbohydrates	39.8 g/day Standard Deviation 48.31	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Lipids	10.5 g/day Standard Deviation 26.56	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Proteins	1.0 g/day Standard Deviation 1.65	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Sodium	28.0 mmol/day Standard Deviation 83.64	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Potassium	1.9 mmol/day Standard Deviation 26.44	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Calcium	1.3 mmol/day Standard Deviation 6.42	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Absorption of Magnesium	-2.2 mmol/day Standard Deviation 5.06	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly Parenteral Support (PS) Volume	-4688.1 mL Standard Deviation 3150.67	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Volume	-5312.6 mL Standard Deviation 5463.54	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Carbohydrates	-3547.1 kJ Standard Deviation 6375.32	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Carbohydrates	-4914.8 kJ Standard Deviation 2452.10	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Lipids	-260.3 kJ Standard Deviation 1361.60	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Lipids	-42.2 kJ Standard Deviation 1869.08	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Proteins	-879.3 kJ Standard Deviation 1939.60	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Proteins	-1057.7 kJ Standard Deviation 983.93	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Sodium	-473.7 mmol Standard Deviation 440.09	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Sodium	-475.7 mmol Standard Deviation 506.37	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Potassium	-35.6 mmol Standard Deviation 73.88	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Potassium	-58.9 mmol Standard Deviation 51.64	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Magnesium	1.6 mmol Standard Deviation 9.02	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=8 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Change in Weekly PS Magnesium	-5.8 mmol Standard Deviation 14.84	—

SECONDARY outcome

Timeframe: Week 56

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

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Anti-glepaglutide Antibodies	9 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Reactivity to ZP1848	8 Participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Cross-reactivity to Glucagon-like Peptide-2 (GLP-2)	1 Participants	—

SECONDARY outcome

Timeframe: Week 56

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

Outcome measures

Measure	Baseline Group - Week 0 n=10 Participants Absorption of wet weight/fluids measured at baseline visit (Week 0).	Week 24 Group Absorption of wet weight/fluids measured at Week 24 visit. The group is the same as the group at Week 0 visit.
Glepaglutide Neutralizing Antibodies	8 Participants	—

Adverse Events

Once-weekly Glepaglutide

Serious events: 6 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Measure	Once-weekly Glepaglutide n=10 participants at risk All 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Injury, poisoning and procedural complications Stoma obstruction	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Nervous system disorders Altered state of consciousness	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Crohn's disease	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Pelvic fluid collection	10.0% 1/10 • Number of events 3 • Safety data cover the period since the first administrated dose till Week 56.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Device related sepsis	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Urinary tract infection	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Stoma site abscess	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.

Other adverse events

Measure	Once-weekly Glepaglutide n=10 participants at risk All 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.
Investigations Weight decreased	30.0% 3/10 • Number of events 3 • Safety data cover the period since the first administrated dose till Week 56.
Investigations Gastrointestinal stoma output abnormal	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Investigations Urine output decreased	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Investigations Weight increased	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Investigations Blood alkaline phosphatase increased	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Investigations Blood creatinine increased	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Investigations Gastrointestinal stoma output increased	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	80.0% 8/10 • Number of events 10 • Safety data cover the period since the first administrated dose till Week 56.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Vascular disorders Hot flush	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Vascular disorders Hypotension	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Vascular disorders Vasculitis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Nervous system disorders Dizziness	30.0% 3/10 • Number of events 3 • Safety data cover the period since the first administrated dose till Week 56.
Nervous system disorders Post viral fatigue syndrome	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Injection site pain	70.0% 7/10 • Number of events 129 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Injection site reaction	50.0% 5/10 • Number of events 19 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Oedema peripheral	50.0% 5/10 • Number of events 6 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Injection site pruritus	30.0% 3/10 • Number of events 26 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Fatigue	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Injection site erythema	20.0% 2/10 • Number of events 22 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Influenza like illness	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Malaise	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
General disorders Thirst	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Ear and labyrinth disorders Hypoacusis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Ear and labyrinth disorders Vertigo	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Abdominal pain	30.0% 3/10 • Number of events 4 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Diarrhoea	30.0% 3/10 • Number of events 3 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Abdominal distension	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Abdominal hernia	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Abdominal pain upper	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Gastrointestinal disorders Stomal hernia	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Investigations Alanine aminotransferase increased	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Respiratory, thoracic and mediastinal disorders Asthma	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Musculoskeletal and connective tissue disorders Back pain	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Musculoskeletal and connective tissue disorders Muscle spasms	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Musculoskeletal and connective tissue disorders Osteoarthritis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Musculoskeletal and connective tissue disorders Torticollis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Urinary tract infection	20.0% 2/10 • Number of events 7 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations COVID-19	20.0% 2/10 • Number of events 3 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Catheter site infection	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Conjunctivitis	10.0% 1/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Erysipelas	10.0% 1/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Folliculitis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Nasopharyngitis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Oesophageal candidiasis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Oral candidiasis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Pneumonia	10.0% 1/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Sinusitis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Infections and infestations Tooth abscess	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Metabolism and nutrition disorders Dehydration	30.0% 3/10 • Number of events 4 • Safety data cover the period since the first administrated dose till Week 56.
Metabolism and nutrition disorders Decreased appetite	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Metabolism and nutrition disorders Hypertriglyceridaemia	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Metabolism and nutrition disorders Hypophosphataemia	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Skin and subcutaneous tissue disorders Stoma site dermatitis	20.0% 2/10 • Number of events 2 • Safety data cover the period since the first administrated dose till Week 56.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Cardiac disorders Supraventricular extrasystoles	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Renal and urinary disorders Nephrolithiasis	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.
Reproductive system and breast disorders Ovarian cyst	10.0% 1/10 • Number of events 1 • Safety data cover the period since the first administrated dose till Week 56.

Additional Information

Head of clinical operations

Zealand Pharma A/S

Phone: +45 8877 3600

Email: info@zealandpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place