Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: ZP1848-230292024-512486-14-00U1111-1302-6092
• Study Type: interventional
• Target: 90
• Locations: 12 countries
• Sites: 23

Brief Summary

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.

Conditions

Short Bowel Syndrome

Keywords

Intestinal Failure; Pathologic Processes; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Short Bowel Syndrome; Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in weekly Parenteral Support (PS) volume

  Baseline to Week 24

Secondary Outcomes (10)

• Proportion of participants achieving clinical response

  Baseline to Week 52

• Proportion of participants achieving clinical response

  Baseline to Week 20 and Week 24

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

  Baseline to Week 52

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

  Baseline to Week 24

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

  Baseline to Week 52

Study Arms (2)

Glepaglutide Group

EXPERIMENTAL

Drug: Glepaglutide

Placebo Group

PLACEBO COMPARATOR

Placebo for glepaglutide

Other: Placebo

Interventions

Glepaglutide DRUG

Subcutaneous (SC) injections twice weekly

Also known as: ZP1848

Glepaglutide Group

Placebo OTHER

SC injections twice weekly

Placebo Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (23)

Washington University Center for Advanced Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Lied Transplant Center at Nebraska Medical Center

Omaha, Nebraska, 68105, United States

RECRUITING

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, 10032, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Universitätsklinikum AKH Wien

Vienna, State of Vienna, 1090, Austria

RECRUITING

Rigshospitalet-Blegdamsvej 9

Copenhagen, 2100, Denmark

RECRUITING

AP-HP - Hôpital Beaujon

Clichy, 92118, France

RECRUITING

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

RECRUITING

Eugastro Klinische Studien GmbH

Leipzig, Saxony, 4103, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

Asklepios Klinik St. Georg

Hamburg, Germany

RECRUITING

Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika

Budapest, 1082, Hungary

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS

Rome, Lazio, 00136, Italy

RECRUITING

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Oslo Universitetssykehus HF, Ullevål

Oslo, 0450, Norway

RECRUITING

Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

Lodz, Lódzkie, 90-531, Poland

RECRUITING

Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego

Warsaw, 00-416, Poland

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

RECRUITING

Sahlgrenska Universitets sjukhuset

Gothenburg, 413 46, Sweden

RECRUITING

Karolinska Universitetssjukhuset Solna

Solna, 171 64, Sweden

RECRUITING

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Failure; Pathologic Processes; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Syndrome

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 30, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): October 23, 2028
• Study Completion (Estimated): February 28, 2032
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); PL (2); FR (1); DE (5); NL (1); SE (2); NO (1); ES (3); AU (1); IT (1); US (4); HU (1)