Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) (EASE SBS 1)

Zealand Pharma

Status and phase: Completed; Phase 3

Conditions: Short Bowel Syndrome

Treatments: Drug: glepaglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03690206

ZP1848-17111

Details and patient eligibility

About

The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Full description

A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients with short bowel syndrome (SBS).

Enrollment: 106 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activity.
• Diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm and considered stable with regard to PS need. No restorative surgery planned in the trial period.
• Requiring PS at least 3 days per week and maintains a stable PS volume for at least 2 weeks.
• In case of remnant colon: documented colonoscopy which does not give rise to any safety concerns.

Exclusion criteria

• More than 2 SBS-related or PS-related hospitalizations within 6 months prior to Screening. No SBS-related hospitalizations within 30 days prior to randomization.
• Poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
• Bowel obstruction.
• Known radiation enteritis or significant villous atrophy.
• 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.
• Clinically significant abnormal ECG.
• Repeated systolic blood pressure measurements > 180 mm Hg.
• Human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease.
• Any history of colon cancer. History of any other cancers unless disease-free state for at least 5 years.
• Estimated creatinine clearance < 30 mL/min.
• Severe hepatic impairment.
• Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening.
• Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to Screening.
• Unstable systemic immunosuppressive therapy within 3 months prior to Screening.
• Unstable biological therapy within 6 months prior to Screening.
• Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods.
• Previous exposure to glepaglutide.
• Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.
• Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 3 patient groups, including a placebo group

Glepaglutide SC injections twice weekly

Experimental group

Description:

Intervention: Glepaglutide

Treatment:

Drug: glepaglutide

Glepaglutide SC injections once weekly and placebo once weekly

Experimental group

Description:

Intervention: Glepaglutide

Treatment:

Drug: Placebo

Drug: glepaglutide

Placebo SC injections twice weekly

Placebo Comparator group

Description:

Intervention: Placebo

Treatment:

Drug: Placebo