A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)

NCT07742735 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: TA799-0252026-526274-16-00
• Study Type: interventional
• Target: 124
• Locations: 21 countries
• Sites: 90

Brief Summary

This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24 weeks of study treatment. It is expected that approximately 124 participants will be randomized worldwide to either apraglutide or placebo in a 1:1 ratio in this trial.

Conditions

Short Bowel Syndrome (SBS); SBS Associated With Intestinal Failure (SBS-IF)

Keywords

Short Bowel Syndrome; Intestinal Failure; SBS; SBS-IF

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in actual weekly PS volume at Week 24.

  At Week 24

Secondary Outcomes (12)

• Participants who achieve clinical response in actual weekly PS volume (at least 20% reduction from baseline) at both Week 20 and Week 24.

  At both Week 20 and Week 24

• Participants who achieve a reduction of PS days per week (categorical) from baseline at Week 24.

  At Week 24

• Participants who achieve a reduction of at least 1 PS day per week from baseline at Week 24.

  At Week 24

• Participants reaching enteral autonomy at Week 24.

  At Week 24

• Absolute change from baseline in actual weekly PS volume at Week 24.

  At Week 24

Study Arms (2)

Active

EXPERIMENTAL

Apraglutide subcutaneous (SC) injections, once weekly

Drug: Apraglutide

Placebo

PLACEBO COMPARATOR

Placebo SC injections, once weekly

Drug: Placebo

Interventions

Apraglutide DRUG

Apraglutide is a synthetic peptide analogue of glucagon-like peptide-2 (GLP-2), which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2. Participants will be administered or will self-administer a weekly SC injection of apraglutide.

Active

Placebo DRUG

Participants will be administered or will self-administer a weekly single SC injection of placebo in the matching injection volumes.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• VectivBio AG: lead
• PSI CRO: collaborator

Study Sites (94)

Ronald Reagan UCLA Medical Center, Center for the Health Sciences

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Denver Health Medical Center

Denver, Colorado, 80204, United States

NOT YET RECRUITING

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

NOT YET RECRUITING

University of Florida Health (UF Health)

Gainesville, Florida, 32610, United States

NOT YET RECRUITING

GI Pros

Naples, Florida, 34102, United States

RECRUITING

Cleveland Clinic Florida

Weston, Florida, 33331, United States

NOT YET RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

NOT YET RECRUITING

UofL Physicians - Colon & Rectal Surgery

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

NOT YET RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

NOT YET RECRUITING

Mount Sinai Medical Center, RMTI - Intestinal Transplantation & Rehabilitation

New York, New York, 10029, United States

NOT YET RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Gastro Health - Clifton

Cincinnati, Ohio, 45219, United States

NOT YET RECRUITING

Cleveland Clinic - Cleveland

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

OSU Wexner Medical Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Buenos Aires Italian Hospital

Buenos Aires, C1199ABB, Argentina

NOT YET RECRUITING

Allende Sanatorium

Córdoba, X5000JHQ, Argentina

NOT YET RECRUITING

San Martin General La Plata Acute General Regional Hospital

La Plata, B1904CFU, Argentina

NOT YET RECRUITING

CDC Medical Center

Luján, M5505, Argentina

NOT YET RECRUITING

St Vincent's Hospital (Melbourne) Ltd

Fitzroy, VIC 3065, Australia

NOT YET RECRUITING

Austin Hospital

Heidelberg, VIC 3084, Australia

NOT YET RECRUITING

Royal Brisbane and Women's Hospital, Gastroenterology and Hepatology

Herston, QLD 4029, Australia

NOT YET RECRUITING

Fiona Stanley Hospital, Harry Perkins Medical Research Institute

Perth, WA 6150, Australia

NOT YET RECRUITING

Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Surgery

Linz, Upper Austria, 4010, Austria

NOT YET RECRUITING

University Hospital Graz

Graz, 8010, Austria

NOT YET RECRUITING

University Hospital Antwerp (UZA), Department of Gastroenterology and Hepatology

Edegem, 2650, Belgium

NOT YET RECRUITING

University Hospitals Leuven, Campus Gasthuisberg, Department of Gastroenterology

Leuven, 3000, Belgium

NOT YET RECRUITING

Hospital Sao Marcos

Teresina, Piauí, 64001-280, Brazil

NOT YET RECRUITING

Caxias Do Sul University / Clinical Research For Multicenter Studies Institute

Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil

NOT YET RECRUITING

Porto Alegre Clinical Hospital (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

NOT YET RECRUITING

Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

NOT YET RECRUITING

Regional Medical School Foundation (CIP HB/FAMERP)

São José do Rio Preto, São Paulo, 15090-000, Brazil

NOT YET RECRUITING

QualiVida Higienopolis - Hapvida NotreDame

São Paulo, São Paulo, 01233-000, Brazil

NOT YET RECRUITING

University of São Paulo Faculty of Medicine Clinics Hospital

São Paulo, São Paulo, 05403-000, Brazil

NOT YET RECRUITING

Pacific Gastroenterology Associates

Vancouver, British Columbia, V6Z 2K5, Canada

NOT YET RECRUITING

CHUM - University of Montreal Hospital Centre

Montreal, Quebec, H2X 3E4, Canada

NOT YET RECRUITING

University Hospital Brno, Clinic of Internal Medicine - Gastroenterology

Brno, 625 00, Czechia

NOT YET RECRUITING

University Hospital Hradec Kralove, 3rd Internal Clinic of Geronto-Metabolic

Hradec Králové, 500 05, Czechia

NOT YET RECRUITING

University Hospital Kralovske Vinohrady, Internal Clinic

Prague, 100 00, Czechia

NOT YET RECRUITING

General University Hospital in Prague

Prague, 128 08, Czechia

NOT YET RECRUITING

Rigshospitalet - University Hospital Copenhagen

Copenhagen, DK-2100, Denmark

NOT YET RECRUITING

Beaujon Hospital - APHP

Clichy, 92110, France

NOT YET RECRUITING

Hospices Civils de Lyon - Lyon Sud

Lyon, 69310, France

NOT YET RECRUITING

Nantes University Hospital Center - Hotel Dieu Hospital

Nantes, 44000, France

NOT YET RECRUITING

Bordeaux University Hospital Center - Haut-Leveque Hospital, Haut-Leveque Hospital

Pessac, 33600, France

NOT YET RECRUITING

Nancy Regional University Hospital Center - Brabois Hospital

Vandœuvre-lès-Nancy, 54500, France

NOT YET RECRUITING

University Hospital Heidelberg, Department of Endocrinology and Metabolism

Heidelberg, Baden-Wurttemberg, 69120, Germany

NOT YET RECRUITING

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

NOT YET RECRUITING

Asklepios Clinic St. Georg

Hamburg, Free and Hanseatic City of Hamburg, 20099, Germany

NOT YET RECRUITING

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

NOT YET RECRUITING

University Duisburg-Essen, University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

NOT YET RECRUITING

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

University Hospital Aachen AoeR

Aachen, Rhine-Westphalia, 52074, Germany

NOT YET RECRUITING

Charite - University Hospital Berlin

Berlin, State of Berlin, 10117, Germany

NOT YET RECRUITING

Semmelweis University, Department of Surgery, Transplantation and Gastroenterology

Budapest, H-1082, Hungary

NOT YET RECRUITING

University of Szeged, Department of Internal Medicine- Western Site

Szeged, H-6725, Hungary

NOT YET RECRUITING

Rambam Health Care Campus, Institute of Gastroenterology, Nutrition Clinic

Haifa, 3109601, Israel

NOT YET RECRUITING

Shaare Zedek Medical Center, Digestive Diseases Institute, Nutrition Clinic

Jerusalem, 9103102, Israel

NOT YET RECRUITING

Meir Medical Center, Institute of Gastroenterology and Liver Diseases

Kfar Saba, 4428164, Israel

NOT YET RECRUITING

The Tel Aviv Sourasky Medical Center, Institute of Gastrointestinal and Liver Diseases, Nutrition Clinic

Tel Aviv, 64239, Israel

NOT YET RECRUITING

Chaim Sheba Medical Center, Institute of Gastrointestinal Diseases, Nutrition Unit

Tel Litwinsky, 5262000, Israel

NOT YET RECRUITING

Polyclinic San Matteo, IRCCS

Pavia, Lombardy, 27100, Italy

NOT YET RECRUITING

University Hospital of Padova

Padova, Veneto, 35128, Italy

NOT YET RECRUITING

IRCCS University Hospital of Bologna, Polyclinic S. Orsola-Malpighi

Bologna, 40138, Italy

NOT YET RECRUITING

Careggi University Hospital

Florence, 50134, Italy

NOT YET RECRUITING

Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

Milan, 20122, Italy

NOT YET RECRUITING

University Hospital City of Health and Science of Turin - Hospital Molinette

Torino, 10126, Italy

NOT YET RECRUITING

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, 221-0855, Japan

NOT YET RECRUITING

Saga-Ken Medical Centre Koseikan

Saga, Saga-ken, 840-8571, Japan

NOT YET RECRUITING

Kagawa University Hospital

Kagawa, 761-0793, Japan

NOT YET RECRUITING

Radboud University Medical Center (Radboudumc)

Nijmegen, 6525GA, Netherlands

NOT YET RECRUITING

Non-Public Healthcare Facility Stadmedica, Ambulatory Specialist Care

Bydgoszcz, 85-391, Poland

NOT YET RECRUITING

Medrise Sp. z o.o. (LLC)

Lublin, 20-582, Poland

NOT YET RECRUITING

Jerzy Gromkowski Provincial Specialist Hospital

Wroclaw, 51-149, Poland

NOT YET RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

NOT YET RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

NOT YET RECRUITING

University Hospital Virgen del Rocio (HUVR)

Seville, Andalusia, 41013, Spain

NOT YET RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807377, Taiwan

NOT YET RECRUITING

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

NOT YET RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

NOT YET RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

NOT YET RECRUITING

Phramongkutklao Hospital

Bangkok, 10400, Thailand

NOT YET RECRUITING

Ramathibodi Hospital

Bangkok, 10400, Thailand

NOT YET RECRUITING

Siriraj Hospital

Bangkok, 10700, Thailand

NOT YET RECRUITING

Songklanagarind Hospital

Hat Yai, 90110, Thailand

NOT YET RECRUITING

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, 30000, Thailand

NOT YET RECRUITING

St Mark's Hospital

London, Middlesex, HA1 3UJ, United Kingdom

NOT YET RECRUITING

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

NOT YET RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

NOT YET RECRUITING

Royal London Hospital

London, E1 1FR, United Kingdom

NOT YET RECRUITING

Northern Care Alliance NHS Foundation Trust, Intestinal Failure Unit

Salford, M6 8HD, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Failure

Interventions

apraglutide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emie Liu, MD

CONTACT

+41 61 551 30 30; clinicaltrialenquiries@ironwoodpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and other site personnel, participants, and CRO and Sponsor personnel will be blinded regarding the treatment arm except for designated unblinded staff.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 4, 2026

Record last verified: 2026-08

Locations

AR (4); CA (2); BR (7); IL (5); US (17); DK (1); NL (1); TH (6); JP (3); KR (3); IT (6); PL (3); ES (1); FR (5); DE (8); GB (5); AU (2); TW (3); HU (2); BE (2); CZ (4)