Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Phase 3RecruitingNCT07197944

Zealand Pharma90 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Short Bowel Syndrome

Interventions

GlepaglutideDRUG

Subcutaneous (SC) injections twice weekly

PlaceboOTHER

SC injections twice weekly

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (31)

Outcomes

Primary Outcomes

Change in weekly Parenteral Support (PS) volume

Time frame: Baseline to Week 24

Secondary Outcomes

Proportion of participants achieving clinical response

Defined as achieving a reduction of at least 20% in weekly PS volume

Time frame: Baseline to Week 52

Proportion of participants achieving clinical response

Defined as achieving a reduction of at least 20% in weekly PS volume

Time frame: Baseline to Week 20 and Week 24

Proportion of participants with a reduction in days on PS ≥1 day/week

Time frame: Baseline to Week 52

Proportion of participants with a reduction in days on PS ≥1 day/week

Time frame: Baseline to Week 24

Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)

Time frame: Baseline to Week 52

Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)

Time frame: Baseline to Week 24

Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status

PGIC scoring categories are: 'Much better', 'A little better', 'No change', 'A little worse', and 'Much worse'

Time frame: Week 24

Change in weekly PS volume

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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The University of Chicago Medicine

Chicago, Illinois, United States

RECRUITING

Washington University Center for Advanced Medicine

St Louis, Missouri, United States

RECRUITING

Lied Transplant Center at Nebraska Medical Center

Omaha, Nebraska, United States

RECRUITING

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

NOT_YET_RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

RECRUITING

Universitätsklinikum AKH Wien

Vienna, State of Vienna, Austria

RECRUITING

Universitair Ziekenhuis (UZ) Leuven

Leuven, Belgium

RECRUITING

Rigshospitalet-Blegdamsvej 9

Copenhagen, Denmark

RECRUITING

Helsingin Yliopistollinen Keskussairaala

Helsinki, Finland

RECRUITING

AP-HP - Hôpital Beaujon

Clichy, France

RECRUITING

...and 21 more locations