Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

Phase 3Active Not RecruitingNCT04881825

Zealand Pharma129 enrolled

Overview

This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

129

Conditions

Short Bowel Syndrome

Interventions

GlepaglutideDRUG

Glepaglutide will be delivered in a single-use autoinjector.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent obtained before any trial-related activity * Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127) Exclusion Criteria: * 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 confound the planned assessments of the trial * Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with remnant colon). Note. The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator * Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of 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

Locations (19)

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Mayo Clinic College of Medicin

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Incidence and type of Adverse Events (AEs)

For AEs with onset or worsening following Visit 1

Time frame: After 108 weeks

Secondary Outcomes

Incidence and type of Serious Adverse Events (SAEs)

For AEs with onset or worsening following Visit 1

Time frame: After 108 weeks

Incidence and type of Adverse Events of Special Interest (AESIs)

For AEs with onset or worsening following Visit 1

Time frame: After 108 weeks

Change in body temperature

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in heart rate

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in blood pressure

Seated diastolic and systolic blood pressure

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in body weight

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG)

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in hematology - hemoglobin

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in hematology - hematocrit

Data from ClinicalTrials.gov

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University of Nebraska Medical Center

Omaha, Nebraska, United States

Vanderbilt University Medical Center, Nashville

Nashville, Tennessee, United States

Universitair Ziekenhuis Leuven

Leuven, Belgium

Rigshospitalet

Copenhagen, Denmark

Hôpital Beaujon

Clichy, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Bonn

Bonn, Germany

...and 9 more locations

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in hematology - white blood cell count

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in hematology - platelet count

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - sodium

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - potassium

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - chloride

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - bicarbonate

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - blood urea nitrogen

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - creatinine

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - creatinine clearance

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - glucose

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - calcium

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - phosphorous

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - alkaline phosphatase

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - alanine aminotransferase (ALT)

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - aspartate aminotransferase (AST)

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - International Normalized Ratio (INR)

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - gamma-glutamyl transferase (GGT)

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - lactic dehydrogenase

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - conjugated bilirubin

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - total bilirubin

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - total protein

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - albumin

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - amylase

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - uric acid

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in biochemistry - C-reactive protein

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in urinalysis - blood

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in urinalysis - glucose

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in urinalysis - leukocytes

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in urinalysis - pH

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in urinalysis - osmolality

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in urinalysis - protein

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in urinalysis - sodium

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Change in urinalysis - potassium

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Anti-glepaglutide antibodies

Time frame: Week 0, Week 108

Antibody reactivity to ZP1848

Time frame: Week 0, Week 108

Cross-reactivity to glucagon-like peptide-2 (GLP-2)

Time frame: Week 0, Week 108

Glepaglutide neutralizing antibodies

Time frame: Week 0, Week 108

Reduction in weekly Parenteral Support (PS) volume

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Reduction of at least 20 percent in weekly PS volume

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Reduction in days on PS greater than or equal to 1 day per week

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108

Reduction in weekly PS volume of 100 percent (weaned off)

Time frame: Week 0 in lead-in trial (EASE SBS 1), Week 108