Can a weekly injection ease the burden of short bowel syndrome?

NCT ID NCT07742735

Disease control Sponsor: VectivBio AG Source: ClinicalTrials.gov ↗

First seen Aug 03, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether apraglutide, a synthetic version of a natural gut hormone, can help adults with short bowel syndrome and intestinal failure reduce their need for intravenous nutrition (parenteral support). Participants receive either apraglutide or a placebo as a weekly injection for 24 weeks. The main goal is to see if the drug can lower the weekly volume of parenteral support needed, which could improve quality of life and reduce complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: apraglutide (a synthetic GLP-2 analogue given as a weekly injection)
What this could lead to: If successful, apraglutide could become a treatment that helps people with short bowel syndrome reduce their dependence on intravenous nutrition, improving daily life and reducing complications.
What could go wrong: This is a phase 3 trial, but results are not guaranteed. The drug may not work for everyone, and side effects are possible. The study is relatively small (124 participants), so findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must be ≥18 years of age, at the time of signing the informed consent. * Male and female participants with SBS-IF, receiving PS secondary to surgical resection of the small intestine with residual length ≥10 cm to \<200 cm from duodeno-jejunal flexure, based on available clinical and/or medical/surgical records, and with either: (a.) CIC remaining and neither jejunostomy nor ileostomy with the latest intestinal resection resulting in SBS-IF being at least 12 months prior to Screening OR (b.) Jejunostomy or ileostomy with the latest intestinal resection resulting in SBS-IF being at least 6 months prior to Screening. * BMI of ≥18.5 to \<30 kg/m2 at randomization. * Individuals of any gender identity, assigned male or female at birth are eligible to participate. Male participants: Male participants with a female partner of childbearing potential must commit to practice highly effective methods of contraception (eg, condom, vasectomy) and abstain from sperm donation during the study and for 2 weeks after the EOT/Early Discontinuation (ED) Visit. Female participants: Women of childbearing potential must agree to practice effective contraception and to use a highly effective method of contraception during the study and for 4 weeks after the EOT/ED Visit. To be considered sterilized or infertile, female participants must have undergone surgical sterilization (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or be postmenopausal (defined as at least 12 months amenorrhea without an alternative medical cause; a follicle-stimulating hormone \[FSH\] test \[with or without estradiol\] is required to confirm if there is doubt). Women who do not engage in heterosexual intercourse will be allowed to join the study without contraception following a thorough discussion with the investigator to determine if this is feasible for the participant. The following are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, postovulation methods, withdrawal (coitus interruptus), spermicides only, and the lactational amenorrhea method. * Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. * PS requirement of at least 3 days per week as assessed before Screening, at the end of optimization, and at the time of randomization. * Participant is considered optimized (average drinking volume is ≥1.0 L and ≤3.5 L per day and the average urinary volume is ≥0.8 L and ≤2.5 L per day) at study Visit 2a, 2b, or 2c. * Participant is considered stable with regard to PS volume requirement, drinking volume, and urinary output at last Stabilization Phase Visit and Visit 4 when the actual PS usage matches prescribed PS (±10% deviation in volume from the last optimization visit), average urine volume at the last stabilization visit and randomization visit match (±25% deviation from last optimization visit is acceptable), while the average drinking volume is constant (the 48-hour oral intake differs from the last optimization visit by less than 10% and minimum 1.0 and maximum 3.5 L per day) and average urine volume is ≥0.8 L and ≤2.5 L per day. * Willingness to adhere to an individual predefined drinking menu and urine measurements during the 48-hour fluid balance periods. * No planned restorative surgery or major intestinal surgery (more than 10% intestinal resection or surgery that changes anatomy group, ie, CIC or stoma) from the signing of informed consent through completion of the SFU visit. * Willingness to undergo either a colonoscopy or CT/MRI colonography (if anatomically feasible and medically appropriate) and have any identified polyps removed. Exclusion Criteria: * Pregnancy and/or lactation and/or plans to become pregnant or to breastfeed. * Major abdominal surgery (more than 10% intestinal resection or surgery that changes anatomy group) in the last 6 months prior to Screening Visit. Surgery for feeding tube placement and cholecystectomy allowed, after discussion with medical monitor and appropriate documentation. Any planned surgical procedures during the study duration must be discussed with the medical monitor prior to enrollment, with appropriate documentation of approval of eligibility, if applicable. * Ultra-short gut (residual length \<10 cm from duodeno-jejunal flexure). * A history of clinically significant intestinal adhesions increasing the risk of GI obstruction and/or GI contrast study(ies) of remaining small bowel suggesting subacute intestinal obstruction or mild stricture within 6 months prior to Screening. * Constipation that is not adequately managed by dietary recommendations, laxatives, or cathartic medications. * Active or untreated enterocutaneous fistula. * History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer. * Diagnosis of any variant of familial adenomatous polyposis or comparable polyposis syndrome. * Active inflammatory bowel disease or any other acute or chronic related underlying medical condition that, in the opinion of the investigator, would limit the participant's ability to complete or participate in the study, or confound study results. Discussion with the medical monitor is required. * Sepsis experienced within the previous 2 months prior to or during Screening; or a central venous catheter infection requiring the use of systemic antibiotics within 30 days prior to or during Screening, with the exception of systemic antibiotics administered for \<72 hours while awaiting the results of pending blood culture(s) that turn out negative (ie, \<72 hours empiric systemic antibiotics while ruling out a central venous catheter infection is allowed as long as the culture turns out negative). * Decompensated heart failure (New York Heart Association class III-IV) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the previous 6 months prior to Screening. * Radiation enteritis, scleroderma, or residual evidence of intestinal dysmotility, including pseudo-obstruction and Hirschsprung's disease, coeliac disease, refractory or tropical sprue. * History of alcohol or drug abuse within the previous 12 months prior to Screening that, in the opinion of the investigator, could interfere with study participation, compliance, and safety of participants. * Child-Pugh scale Class C for liver disease. * Evidence of chronic renal disease as demonstrated by inadequate renal function, which is defined as estimated glomerular filtration rate \<20 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology formula). * Positive results for HIV, hepatitis A, B, and/or C tests at the Screening Visit. Note: Participants recovered from hepatitis B or C can be enrolled, ie, they have markers of the infection, but the viral load is undetectable. Participants with evidence of an acute or chronically active hepatitis B or C infection should be excluded. If a participant has a positive hepatitis A immunoglobulin M test, this would indicate an acute infection and the participant is ineligible, but they may be eligible for rescreening after recovery. Participants with positive HIV test results and undetectable viral loads may be rescreened (in case the initial test was a false positive). * Clinically significant concurrent illness (eg, uncontrolled hypertension, pancreatic or gallbladder disease) or finding on physical examination or clinical laboratory test after signing the ICF but before receiving the first dose of IMP. Note: The investigator will determine if a finding is clinically significant. The investigator will consider whether the finding 1) could prevent the participant from performing any study procedure or assessment, 2) represents a condition that would be exclusionary, 3) could represent a safety concern if the participant participated in the study, or 4) could confound any study assessment. * Elevated liver enzymes during the screening period: (a.) ALT or AST \>5 × upper limit of normal (ULN); (b.) ALT or AST \>3 × ULN and total bilirubin (TBL) \>2 × ULN or international normalized ratio (INR) \>1.5 for a person not using anticoagulant drug and INR \>3 for a person on anticoagulant therapy such as warfarin; (c.) ALT or AST \>3 × ULN and clinical signs of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia; (d.) Participants with serum conjugated bilirubin \>34 μmol/L during 2 consecutive measurements. * Use of diuretics, anti-diarrheals, and other common concomitant medications used in SBS-IF if dosing is not stable within 14 days prior to randomization. * New drug treatment other than biologic therapies, or a change to the dose or dosing interval of an existing drug treatment other than a biologic, within 1 month prior to randomization. In cases of weight loss or weight gain, dose adjustments that enable the same drug unit/kg dosing (eg, mg/kg) for weight-based dosing are permitted within 1 month prior to randomization after discussion with the medical monitor and proper documentation. * New biologic therapy or changes to dose or dosing interval of existing biologic therapy within 3 months prior to Screening, unless the dose adjustment was due to a change in weight and maintained the same drug-unit/kg (eg, mg/kg) weight-based dosing. Switching from a reference biologic product to a biosimilar, while maintaining the same dose and dosing interval, is permitted outside the 3 months prior to the screening window and/or during the study. * Use of dipeptidyl peptidase-4 inhibitors within 3 months prior to Screening. * At least 2 weeks of treatment with growth factors, such as growth hormone, glutamine, native GLP-2, GLP-1, short acting GLP-2 analogs (eg, teduglutide) or GLP-1 analogs within 3 months before Screening; or treatment with longer acting experimental GLP-2 analogs in the previous 6 months before Screening. Note: Prior discontinuation of GLP-2 analog treatment due to safety concerns or lack of efficacy is an exclusion criterion regardless of wash-out period. For prior discontinuation due to intolerance, the patient may be eligible based on discussion with the medical monitor. The nature of the intolerance must be clearly documented and discussed with the medical monitor. * Citrulline supplements within less than 30 days prior to Screening. * Prior use of apraglutide, or prior randomization in this study. Note: Randomization to placebo in a prior study of apraglutide is not an exclusion criterion. * Known or suspected hypersensitivity to GLP-1 or GLP-2 analogs or any apraglutide excipients. * Known antidrug antibodies (ADAs) against GLP-1 or GLP-2 analogs. * Participation in another interventional clinical study in the last 3 months before screening and during this study (studies with catheter locks or observational studies, which are not a burden on the participant and do not interfere with the participation in this study, are allowed after discussion with the medical monitor). * Incapable of understanding or unwilling to adhere to the study visit schedules and/or other protocol requirements. * Inability to prepare and/or administer the dose of the study intervention or inability to have the dose prepared and/or administered by an appropriately trained care provider. * Any condition, underlying disease, or circumstance, including psychosocial or environmental that, in the opinion of the investigator, could reduce the participant's adherence with the study visit schedule, dosing regimen, or other study requirements. * Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, study staff member, or employee of the sponsor; or the participant is a direct relative of an individual involved in the study.

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Conditions

The condition(s) this trial relates to.

Intestinal Failure short bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SBS associated with intestinal failure (SBS-if) Short bowel syndrome (SBS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

94 sites in 22 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Aberdeen Royal Infirmary
NOT_YET_RECRUITING

Aberdeen, Scotland, AB25 2ZN, United Kingdom
Albany Medical Center
NOT_YET_RECRUITING

Albany, New York, 12208, United States
Allende Sanatorium
NOT_YET_RECRUITING

Córdoba, X5000JHQ, Argentina
Asan Medical Center
NOT_YET_RECRUITING

Seoul, 05505, South Korea
Asklepios Clinic St. Georg
NOT_YET_RECRUITING

Hamburg, Free and Hanseatic City of Hamburg, 20099, Germany
Austin Hospital
NOT_YET_RECRUITING

Heidelberg, VIC 3084, Australia
Beaujon Hospital - APHP
NOT_YET_RECRUITING

Clichy, 92110, France
Bordeaux University Hospital Center - Haut-Leveque Hospital, Haut-Leveque Hospital
NOT_YET_RECRUITING

Pessac, 33600, France
Buenos Aires Italian Hospital
NOT_YET_RECRUITING

Buenos Aires, C1199ABB, Argentina
CDC Medical Center
NOT_YET_RECRUITING

Luján, M5505, Argentina
CHUM - University of Montreal Hospital Centre
NOT_YET_RECRUITING

Montreal, Quebec, H2X 3E4, Canada
Careggi University Hospital
NOT_YET_RECRUITING

Florence, 50134, Italy
Caxias Do Sul University / Clinical Research For Multicenter Studies Institute
NOT_YET_RECRUITING

Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Chaim Sheba Medical Center, Institute of Gastrointestinal Diseases, Nutrition Unit
NOT_YET_RECRUITING

Tel Litwinsky, 5262000, Israel
Charite - University Hospital Berlin
NOT_YET_RECRUITING

Berlin, State of Berlin, 10117, Germany
Cleveland Clinic - Cleveland
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Cleveland Clinic Florida
NOT_YET_RECRUITING

Weston, Florida, 33331, United States
Denver Health Medical Center
NOT_YET_RECRUITING

Denver, Colorado, 80204, United States
Duke University Medical Center
NOT_YET_RECRUITING

Durham, North Carolina, 27710, United States
Far Eastern Memorial Hospital
NOT_YET_RECRUITING

New Taipei City, 220, Taiwan
Fiona Stanley Hospital, Harry Perkins Medical Research Institute
NOT_YET_RECRUITING

Perth, WA 6150, Australia
GI Pros
RECRUITING

Naples, Florida, 34102, United States
Gastro Health - Clifton
NOT_YET_RECRUITING

Cincinnati, Ohio, 45219, United States
General University Hospital in Prague
NOT_YET_RECRUITING

Prague, 128 08, Czechia
Henry Ford Medical Center - Columbus
NOT_YET_RECRUITING

Novi, Michigan, 48377, United States
Hospices Civils de Lyon - Lyon Sud
NOT_YET_RECRUITING

Lyon, 69310, France
Hospital Sao Marcos
NOT_YET_RECRUITING

Teresina, Piauí, 64001-280, Brazil
Hospital of the University of Pennsylvania
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19104, United States
IRCCS University Hospital of Bologna, Polyclinic S. Orsola-Malpighi
NOT_YET_RECRUITING

Bologna, 40138, Italy
Jerzy Gromkowski Provincial Specialist Hospital
NOT_YET_RECRUITING

Wroclaw, 51-149, Poland
Kagawa University Hospital
NOT_YET_RECRUITING

Kagawa, 761-0793, Japan
Kaohsiung Medical University Chung-Ho Memorial Hospital
NOT_YET_RECRUITING

Kaohsiung City, 807377, Taiwan
King Chulalongkorn Memorial Hospital
NOT_YET_RECRUITING

Bangkok, 10330, Thailand
Loyola University Medical Center
NOT_YET_RECRUITING

Maywood, Illinois, 60153, United States
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
NOT_YET_RECRUITING

Milan, 20122, Italy
Maharat Nakhon Ratchasima Hospital
NOT_YET_RECRUITING

Nakhon Ratchasima, 30000, Thailand
MedStar Georgetown University Hospital
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20007, United States
Medrise Sp. z o.o. (LLC)
NOT_YET_RECRUITING

Lublin, 20-582, Poland
Meir Medical Center, Institute of Gastroenterology and Liver Diseases
NOT_YET_RECRUITING

Kfar Saba, 4428164, Israel
Mount Sinai Medical Center, RMTI - Intestinal Transplantation & Rehabilitation
NOT_YET_RECRUITING

New York, New York, 10029, United States
Nancy Regional University Hospital Center - Brabois Hospital
NOT_YET_RECRUITING

Vandœuvre-lès-Nancy, 54500, France
Nantes University Hospital Center - Hotel Dieu Hospital
NOT_YET_RECRUITING

Nantes, 44000, France
Non-Public Healthcare Facility Stadmedica, Ambulatory Specialist Care
NOT_YET_RECRUITING

Bydgoszcz, 85-391, Poland
Northern Care Alliance NHS Foundation Trust, Intestinal Failure Unit
NOT_YET_RECRUITING

Salford, M6 8HD, United Kingdom
OSU Wexner Medical Center
NOT_YET_RECRUITING

Columbus, Ohio, 43210, United States
Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Surgery
NOT_YET_RECRUITING

Linz, Upper Austria, 4010, Austria
Pacific Gastroenterology Associates
NOT_YET_RECRUITING

Vancouver, British Columbia, V6Z 2K5, Canada
Phramongkutklao Hospital
NOT_YET_RECRUITING

Bangkok, 10400, Thailand
Polyclinic San Matteo, IRCCS
NOT_YET_RECRUITING

Pavia, Lombardy, 27100, Italy
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
NOT_YET_RECRUITING

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Porto Alegre Clinical Hospital (HCPA)
NOT_YET_RECRUITING

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
QualiVida Higienopolis - Hapvida NotreDame
NOT_YET_RECRUITING

São Paulo, São Paulo, 01233-000, Brazil
Radboud University Medical Center (Radboudumc)
NOT_YET_RECRUITING

Nijmegen, 6525GA, Netherlands
Ramathibodi Hospital
NOT_YET_RECRUITING

Bangkok, 10400, Thailand
Rambam Health Care Campus, Institute of Gastroenterology, Nutrition Clinic
NOT_YET_RECRUITING

Haifa, 3109601, Israel
Regional Medical School Foundation (CIP HB/FAMERP)
NOT_YET_RECRUITING

São José do Rio Preto, São Paulo, 15090-000, Brazil
Rigshospitalet - University Hospital Copenhagen
NOT_YET_RECRUITING

Copenhagen, DK-2100, Denmark
Ronald Reagan UCLA Medical Center, Center for the Health Sciences
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
Royal Brisbane and Women's Hospital, Gastroenterology and Hepatology
NOT_YET_RECRUITING

Herston, QLD 4029, Australia
Royal London Hospital
NOT_YET_RECRUITING

London, E1 1FR, United Kingdom
Saga-Ken Medical Centre Koseikan
NOT_YET_RECRUITING

Saga, Saga-ken, 840-8571, Japan
Samsung Medical Center
NOT_YET_RECRUITING

Seoul, 06351, South Korea
San Martin General La Plata Acute General Regional Hospital
NOT_YET_RECRUITING

La Plata, B1904CFU, Argentina
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
NOT_YET_RECRUITING

Budapest, H-1082, Hungary
Shaare Zedek Medical Center, Digestive Diseases Institute, Nutrition Clinic
NOT_YET_RECRUITING

Jerusalem, 9103102, Israel
Siriraj Hospital
NOT_YET_RECRUITING

Bangkok, 10700, Thailand
Songklanagarind Hospital
NOT_YET_RECRUITING

Hat Yai, 90110, Thailand
St Mark's Hospital
NOT_YET_RECRUITING

London, Middlesex, HA1 3UJ, United Kingdom
St Vincent's Hospital (Melbourne) Ltd
NOT_YET_RECRUITING

Fitzroy, VIC 3065, Australia
Taichung Veterans General Hospital
NOT_YET_RECRUITING

Taichung, 407219, Taiwan
The Catholic University of Korea, Seoul St. Mary's Hospital
NOT_YET_RECRUITING

Seoul, 06591, South Korea
The Tel Aviv Sourasky Medical Center, Institute of Gastrointestinal and Liver Diseases, Nutrition Clinic
NOT_YET_RECRUITING

Tel Aviv, 64239, Israel
University Duisburg-Essen, University Hospital Essen
NOT_YET_RECRUITING

Essen, North Rhine-Westphalia, 45147, Germany
University Hospital Aachen AoeR
NOT_YET_RECRUITING

Aachen, Rhine-Westphalia, 52074, Germany
University Hospital Antwerp (UZA), Department of Gastroenterology and Hepatology
NOT_YET_RECRUITING

Edegem, 2650, Belgium
University Hospital Bonn
NOT_YET_RECRUITING

Bonn, North Rhine-Westphalia, 53127, Germany
University Hospital Brno, Clinic of Internal Medicine - Gastroenterology
NOT_YET_RECRUITING

Brno, 625 00, Czechia
University Hospital City of Health and Science of Turin - Hospital Molinette
NOT_YET_RECRUITING

Torino, 10126, Italy
University Hospital Erlangen
NOT_YET_RECRUITING

Erlangen, Bavaria, 91054, Germany
University Hospital Graz
NOT_YET_RECRUITING

Graz, 8010, Austria
University Hospital Heidelberg, Department of Endocrinology and Metabolism
NOT_YET_RECRUITING

Heidelberg, Baden-Wurttemberg, 69120, Germany
University Hospital Hradec Kralove, 3rd Internal Clinic of Geronto-Metabolic
NOT_YET_RECRUITING

Hradec Králové, 500 05, Czechia
University Hospital Kralovske Vinohrady, Internal Clinic
NOT_YET_RECRUITING

Prague, 100 00, Czechia
University Hospital Muenster
NOT_YET_RECRUITING

Münster, North Rhine-Westphalia, 48149, Germany
University Hospital Virgen del Rocio (HUVR)
NOT_YET_RECRUITING

Seville, Andalusia, 41013, Spain
University Hospital of Padova
NOT_YET_RECRUITING

Padova, Veneto, 35128, Italy
University Hospitals Birmingham NHS Foundation Trust
NOT_YET_RECRUITING

Birmingham, B15 2TH, United Kingdom
University Hospitals Leuven, Campus Gasthuisberg, Department of Gastroenterology
NOT_YET_RECRUITING

Leuven, 3000, Belgium
University of Florida Health (UF Health)
NOT_YET_RECRUITING

Gainesville, Florida, 32610, United States
University of Szeged, Department of Internal Medicine- Western Site
NOT_YET_RECRUITING

Szeged, H-6725, Hungary
University of São Paulo Faculty of Medicine Clinics Hospital
NOT_YET_RECRUITING

São Paulo, São Paulo, 05403-000, Brazil
UofL Physicians - Colon & Rectal Surgery
NOT_YET_RECRUITING

Louisville, Kentucky, 40202, United States
Vanderbilt University Medical Center
NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
Yokohama Municipal Citizen's Hospital
NOT_YET_RECRUITING

Yokohama, Kanagawa, 221-0855, Japan

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