Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Phase 3Not Yet RecruitingNCT07197944

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.

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

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.