Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-23

Study Completion Date

2032-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

NCT03905707

Short Bowel Syndrome

ACTIVE_NOT_RECRUITING PHASE3

Efficacy and Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07228403

Short Bowel Syndrome (SBS)

ENROLLING_BY_INVITATION PHASE3

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

NCT04881825

Short Bowel Syndrome

ENROLLING_BY_INVITATION PHASE3

The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

NCT04991311

Short Bowel Syndrome

COMPLETED PHASE3

A Phase 2 Trial Testing ZP1848 in Patients With SBS

NCT02690025

Short Bowel Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Short Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to one of two groups (arms) in parallel: one group receives glepaglutide, and the other group receives a placebo. After this initial phase, both groups receive open-label treatment with glepaglutide.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glepaglutide Group

Group Type EXPERIMENTAL

Glepaglutide

Intervention Type DRUG

Subcutaneous (SC) injections twice weekly

Placebo Group

Placebo for glepaglutide

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

SC injections twice weekly

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glepaglutide

Subcutaneous (SC) injections twice weekly

Intervention Type DRUG

Placebo

SC injections twice weekly

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ZP1848

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No