Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS (EASE SBS 5)

Zealand Pharma

Status and phase

Not yet enrolling

Phase 3

Conditions

Short Bowel Syndrome

Treatments

Other: Placebo

Drug: Glepaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT07197944

ZP1848-23029

U1111-1302-6092 (Other Identifier)

2024-512486-14-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.

Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.

Full description

The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).

Enrollment

90 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Signed informed consent;
Age of 18 to 90 years;
A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
Stable PS need of ≥3 days per week;
No restorative surgery planned during the trial period;
Having a stoma or colon in continuity.

Key Exclusion Criteria:

More than 2 SBS- or PS-related hospitalizations within 6 months before screening;
Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;
BMI <18.5 kg/m^2.