Extension trial to evaluate long-term efficacy and safety of glepaglutide in patients with short bowel syndrome

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS) - EaseSBS 2 - Efficacy And Safety Evaluation of Glepaglutide in treatment of SBS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001429-26-NL

Enrollment

145

Registered

2019-04-02

Start date

2019-07-02

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short bowel syndrome MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Glepaglutide Product Code: ZP1848 Pharmaceutical Form: Solution for injection INN or Proposed INN: GLEPAGLUTIDE CAS Number: 914009-86-2 Current Sponsor code: ZP1848 Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient must meet all of the following inclusion criteria: - Signed informed consent Either of the following: - Completed the full treatment period of the lead-in trial (ZP1848-17111), regardless of treatment adherence. OR - Completed the Phase 2 trial (ZP1848-15073). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 99 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46

Exclusion criteria

Exclusion criteria: The patient must be excluded from this trial if any of the following criteria are met: - Withdrew consent from lead-in or Phase 2 trial. - Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confounds planned assessments of the trial. - Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4), citrulline, somatostatin, or analogs thereof within 3 months. Note: Prior glepaglutide trial drug is allowed. - Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods. Highly effective contraception methods and definition of child-bearing potential are described in Section 11.4.4 of there Study Protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety of glepaglutide treatment in short bowel syndrome (SBS) patients ;Secondary Objective: - To evaluate the long-term efficacy of glepaglutide treatment in SBS patients - To evaluate the long-term immunogenicity of glepaglutide and its impact on pharmacokinetics (PK), efficacy, and safety in SBS patients - To evaluate quality of life for SBS patients treated with glepaglutide;Primary end point(s): Safety Endpoints - Incidence and type of AEs (primary endpoint) - Incidence and type of serious adverse events (SAEs) and AESIs - Changes from baseline in: * Vital signs * Electrocardiogram (ECG) - Changes from baseline in: * Hematology * Biochemistry * Urinalysis - Immunogenicity Efficacy Endpoints: - Reduction in weekly PS volume from baseline - Having at least 20% reduction in weekly PS volume from baseline - Reduction in days on PS = 1 day/week from baseline - Reduction in weekly PS volume of 100% (weaned off) ;Timepoint(s) of evaluation of this end point: The primary endpoint will be analyzed using the incidence of AEs occurring in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis. All efficacy endpoints will be analyzed using average weekly results over the 3-month period between visits.	—

Measure

Time frame

Main Objective: To evaluate the long-term safety of glepaglutide treatment in short bowel syndrome (SBS) patients ;Secondary Objective: - To evaluate the long-term efficacy of glepaglutide treatment in SBS patients - To evaluate the long-term immunogenicity of glepaglutide and its impact on pharmacokinetics (PK), efficacy, and safety in SBS patients - To evaluate quality of life for SBS patients treated with glepaglutide;Primary end point(s): Safety Endpoints - Incidence and type of AEs (primary endpoint) - Incidence and type of serious adverse events (SAEs) and AESIs - Changes from baseline in: * Vital signs * Electrocardiogram (ECG) - Changes from baseline in: * Hematology * Biochemistry * Urinalysis - Immunogenicity Efficacy Endpoints: - Reduction in weekly PS volume from baseline - Having at least 20% reduction in weekly PS volume from baseline - Reduction in days on PS = 1 day/week from baseline - Reduction in weekly PS volume of 100% (weaned off) ;Timepoint(s) of evaluation of this end point: The primary endpoint will be analyzed using the incidence of AEs occurring in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis. All efficacy endpoints will be analyzed using average weekly results over the 3-month period between visits.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are: - Change in fluid composite effect (FCE) from baseline - Reduction in calculated energy content of parenteral macronutrients from baseline - Reduction in number of days on PS per week from baseline - Reduction of at least 40% in weekly PS volume from baseline Other efficacy endpoints are: - Reduction in days on PS = 2 days/week from baseline - Reduction in days on PS = 3 days/week from baseline - Reduction in duration of PS infusions per week from baseline - Concentration trough levels of glepaglutide and metabolites - Change in plasma citrulline level from baseline - Change in weekly need for parenteral micronutrients (sodium, potassium, magnesium, and calcium) from baseline - Change in patient-reported outcomes (SBS-I and EQ-5D-5L) from baseline - Reduction in bowel movements or stoma bags emptying from baseline;Timepoint(s) of evaluation of this end point: Per week from baseline	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are: - Change in fluid composite effect (FCE) from baseline - Reduction in calculated energy content of parenteral macronutrients from baseline - Reduction in number of days on PS per week from baseline - Reduction of at least 40% in weekly PS volume from baseline Other efficacy endpoints are: - Reduction in days on PS = 2 days/week from baseline - Reduction in days on PS = 3 days/week from baseline - Reduction in duration of PS infusions per week from baseline - Concentration trough levels of glepaglutide and metabolites - Change in plasma citrulline level from baseline - Change in weekly need for parenteral micronutrients (sodium, potassium, magnesium, and calcium) from baseline - Change in patient-reported outcomes (SBS-I and EQ-5D-5L) from baseline - Reduction in bowel movements or stoma bags emptying from baseline;Timepoint(s) of evaluation of this end point: Per week from baseline

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Countries

Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, United Kingdom, United States

Contacts

Public ContactTina Egegaard CT Manager

Zealand Pharma A/S

teg@zealandpharma.com+45 8877 3600

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026