Short Bowel Syndrome (SBS)Phase 3STARS-2NCT07742735
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)
A Phase 3 study testing Apraglutide in people with Short Bowel Syndrome (SBS) and SBS Associated With Intestinal Failure (SBS-IF), run by VectivBio AG at 94 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome (SBS), SBS Associated With Intestinal Failure (SBS-IF)
- What is being tested?
- Apraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 94 sitesin 22 countries
- Study dates
- Aug 2026to Oct 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
94 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
94 sites in 22 countries
United States17 sites, 17 recruiting
- Not yet recruiting
Albany Medical Center
Albany, New York, 12208
- Not yet recruiting
Gastro Health - Clifton
Cincinnati, Ohio, 45219
- Not yet recruiting
Cleveland Clinic - Cleveland
Cleveland, Ohio, 44195
- Not yet recruiting
OSU Wexner Medical Center
Columbus, Ohio, 43210
- Not yet recruiting
Denver Health Medical Center
Denver, Colorado, 80204
- Not yet recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Not yet recruiting
University of Florida Health (UF Health)
Gainesville, Florida, 32610
- Not yet recruiting
Ronald Reagan UCLA Medical Center, Center for the Health Sciences
Los Angeles, California, 90095
- Not yet recruiting
UofL Physicians - Colon & Rectal Surgery
Louisville, Kentucky, 40202
- Not yet recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
- Recruiting
GI Pros
Naples, Florida, 34102
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Not yet recruiting
Mount Sinai Medical Center, RMTI - Intestinal Transplantation & Rehabilitation
New York, New York, 10029
- Not yet recruiting
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
- Not yet recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Not yet recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
- Not yet recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Germany8 sites, 8 recruiting
- Not yet recruiting
University Hospital Aachen AoeR
Aachen, Rhine-Westphalia, 52074
- Not yet recruiting
Charite - University Hospital Berlin
Berlin, State of Berlin, 10117
- Not yet recruiting
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
- Not yet recruiting
University Hospital Erlangen
Erlangen, Bavaria, 91054
- Not yet recruiting
University Duisburg-Essen, University Hospital Essen
Essen, North Rhine-Westphalia, 45147
- Not yet recruiting
Asklepios Clinic St. Georg
Hamburg, Free and Hanseatic City of Hamburg, 20099
- Not yet recruiting
University Hospital Heidelberg, Department of Endocrinology and Metabolism
Heidelberg, Baden-Wurttemberg, 69120
- Not yet recruiting
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
Brazil7 sites, 7 recruiting
- Not yet recruiting
Caxias Do Sul University / Clinical Research For Multicenter Studies Institute
Caxias do Sul, Rio Grande do Sul, 95070-560
- Not yet recruiting
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903
- Not yet recruiting
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
Porto Alegre, Rio Grande do Sul, 90610-000
- Not yet recruiting
Regional Medical School Foundation (CIP HB/FAMERP)
São José do Rio Preto, São Paulo, 15090-000
- Not yet recruiting
QualiVida Higienopolis - Hapvida NotreDame
São Paulo, São Paulo, 01233-000
- Not yet recruiting
University of São Paulo Faculty of Medicine Clinics Hospital
São Paulo, São Paulo, 05403-000
- Not yet recruiting
Hospital Sao Marcos
Teresina, Piauí, 64001-280
Italy6 sites, 6 recruiting
- Not yet recruiting
IRCCS University Hospital of Bologna, Polyclinic S. Orsola-Malpighi
Bologna, 40138
- Not yet recruiting
Careggi University Hospital
Florence, 50134
- Not yet recruiting
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122
- Not yet recruiting
University Hospital of Padova
Padova, Veneto, 35128
- Not yet recruiting
Polyclinic San Matteo, IRCCS
Pavia, Lombardy, 27100
- Not yet recruiting
University Hospital City of Health and Science of Turin - Hospital Molinette
Torino, 10126
Thailand6 sites, 6 recruiting
- Not yet recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
- Not yet recruiting
Phramongkutklao Hospital
Bangkok, 10400
- Not yet recruiting
Ramathibodi Hospital
Bangkok, 10400
- Not yet recruiting
Siriraj Hospital
Bangkok, 10700
- Not yet recruiting
Songklanagarind Hospital
Hat Yai, 90110
- Not yet recruiting
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, 30000
France5 sites, 5 recruiting
- Not yet recruiting
Beaujon Hospital - APHP
Clichy, 92110
- Not yet recruiting
Hospices Civils de Lyon - Lyon Sud
Lyon, 69310
- Not yet recruiting
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, 44000
- Not yet recruiting
Bordeaux University Hospital Center - Haut-Leveque Hospital, Haut-Leveque Hospital
Pessac, 33600
- Not yet recruiting
Nancy Regional University Hospital Center - Brabois Hospital
Vandœuvre-lès-Nancy, 54500
Israel5 sites, 5 recruiting
- Not yet recruiting
Rambam Health Care Campus, Institute of Gastroenterology, Nutrition Clinic
Haifa, 3109601
- Not yet recruiting
Shaare Zedek Medical Center, Digestive Diseases Institute, Nutrition Clinic
Jerusalem, 9103102
- Not yet recruiting
Meir Medical Center, Institute of Gastroenterology and Liver Diseases
Kfar Saba, 4428164
- Not yet recruiting
The Tel Aviv Sourasky Medical Center, Institute of Gastrointestinal and Liver Diseases, Nutrition Clinic
Tel Aviv, 64239
- Not yet recruiting
Chaim Sheba Medical Center, Institute of Gastrointestinal Diseases, Nutrition Unit
Tel Litwinsky, 5262000
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
- Not yet recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
- Not yet recruiting
St Mark's Hospital
London, Middlesex, HA1 3UJ
- Not yet recruiting
Royal London Hospital
London, E1 1FR
- Not yet recruiting
Northern Care Alliance NHS Foundation Trust, Intestinal Failure Unit
Salford, M6 8HD
Argentina4 sites, 4 recruiting
- Not yet recruiting
Buenos Aires Italian Hospital
Buenos Aires, C1199ABB
- Not yet recruiting
Allende Sanatorium
Córdoba, X5000JHQ
- Not yet recruiting
San Martin General La Plata Acute General Regional Hospital
La Plata, B1904CFU
- Not yet recruiting
CDC Medical Center
Luján, M5505
Australia4 sites, 4 recruiting
- Not yet recruiting
St Vincent's Hospital (Melbourne) Ltd
Fitzroy, VIC 3065
- Not yet recruiting
Austin Hospital
Heidelberg, VIC 3084
- Not yet recruiting
Royal Brisbane and Women's Hospital, Gastroenterology and Hepatology
Herston, QLD 4029
- Not yet recruiting
Fiona Stanley Hospital, Harry Perkins Medical Research Institute
Perth, WA 6150
Czechia4 sites, 4 recruiting
- Not yet recruiting
University Hospital Brno, Clinic of Internal Medicine - Gastroenterology
Brno, 625 00
- Not yet recruiting
University Hospital Hradec Kralove, 3rd Internal Clinic of Geronto-Metabolic
Hradec Králové, 500 05
- Not yet recruiting
University Hospital Kralovske Vinohrady, Internal Clinic
Prague, 100 00
- Not yet recruiting
General University Hospital in Prague
Prague, 128 08
Japan3 sites, 3 recruiting
- Not yet recruiting
Kagawa University Hospital
Kagawa, 761-0793
- Not yet recruiting
Saga-Ken Medical Centre Koseikan
Saga, Saga-ken, 840-8571
- Not yet recruiting
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa, 221-0855
Poland3 sites, 3 recruiting
- Not yet recruiting
Non-Public Healthcare Facility Stadmedica, Ambulatory Specialist Care
Bydgoszcz, 85-391
- Not yet recruiting
Medrise Sp. z o.o. (LLC)
Lublin, 20-582
- Not yet recruiting
Jerzy Gromkowski Provincial Specialist Hospital
Wroclaw, 51-149
South Korea3 sites, 3 recruiting
- Not yet recruiting
Asan Medical Center
Seoul, 05505
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
- Not yet recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Taiwan3 sites, 3 recruiting
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377
- Not yet recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 407219
Austria2 sites, 2 recruiting
- Not yet recruiting
University Hospital Graz
Graz, 8010
- Not yet recruiting
Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Surgery
Linz, Upper Austria, 4010
Belgium2 sites, 2 recruiting
- Not yet recruiting
University Hospital Antwerp (UZA), Department of Gastroenterology and Hepatology
Edegem, 2650
- Not yet recruiting
University Hospitals Leuven, Campus Gasthuisberg, Department of Gastroenterology
Leuven, 3000
Canada2 sites, 2 recruiting
- Not yet recruiting
CHUM - University of Montreal Hospital Centre
Montreal, Quebec, H2X 3E4
- Not yet recruiting
Pacific Gastroenterology Associates
Vancouver, British Columbia, V6Z 2K5
Hungary2 sites, 2 recruiting
- Not yet recruiting
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
Budapest, H-1082
- Not yet recruiting
University of Szeged, Department of Internal Medicine- Western Site
Szeged, H-6725
Denmark1 site, 1 recruiting
- Not yet recruiting
Rigshospitalet - University Hospital Copenhagen
Copenhagen, DK-2100
Netherlands1 site, 1 recruiting
- Not yet recruiting
Radboud University Medical Center (Radboudumc)
Nijmegen, 6525GA
Spain1 site, 1 recruiting
- Not yet recruiting
University Hospital Virgen del Rocio (HUVR)
Seville, Andalusia, 41013
About this study
Official title: A Parallel-group Treatment, Phase 3, Double-blind, Randomized, 2-arm 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)
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.
Read the detailed description
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to investigate the efficacy, safety, and tolerability of apraglutide compared with placebo in adults with SBS-IF. The study population will be representative of the SBS-IF general population and will include adult participants (≥18 years of age) who are dependent on, and who are receiving, PS at least 3 days per week. Eligible participants will be randomized 1:1 to receive SC apraglutide or placebo once weekly for 24 weeks stratified by anatomy (i.e., colon-in-continuity [CIC] or stoma) and baseline parenteral support (PS) volume (i.e., <12 L/week or ≥12 L/week). The number of randomized participants in CIC and stoma will be monitored to ensure approximately equal numbers of CIC and stoma participants are randomized.
The study will consist of 4 periods: a Screening Period prior to randomization (including optimization and stabilization phases), a Treatment Period starting at randomization, a Safety Follow-up (SFU) Period after the last dose of IMP is completed, and an Anti-Drug Antibody (ADA) Follow-up Period beginning after the last dose of IMP.
All participants who complete the IMP treatment will be offered participation in an open label single arm apraglutide long-term extension (LTE) study. Participants who do not wish to continue onto the LTE study will be requested to complete an SFU Visit, which will occur 4 weeks (±1 week) after the last dose of IMP, after which they will transition into ADA Follow-Up period.
- Being tested
- Apraglutide, Placebo
- Keywords
- Short Bowel Syndrome, Intestinal Failure, SBS, SBS-IF
- Medical subject headings
- Short Bowel Syndrome, Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApraglutideDrug
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.
PlaceboDrug
Participants will be administered or will self-administer a weekly single SC injection of placebo in the matching injection volumes.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Apraglutide subcutaneous (SC) injections, once weekly Receives: Drug: Apraglutide |
| Placebo | Placebo comparator | Placebo SC injections, once weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in actual weekly PS volume at Week 24.
Measured: 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.
Measured: At both Week 20 and Week 24
Participants who achieve a reduction of PS days per week (categorical) from baseline at Week 24.
Categorical reduction includes 4 ordered categories: 0 days; 1 day; 2 days; ≥3 days.
Measured: At Week 24
Participants who achieve a reduction of at least 1 PS day per week from baseline at Week 24.
Measured: At Week 24
Participants reaching enteral autonomy at Week 24.
Measured: At Week 24
Absolute change from baseline in actual weekly PS volume at Week 24.
Measured: At Week 24
Participants who achieve clinical response (categorical) in actual weekly PS volume reduction from baseline at both Week 20 and Week 24.
Categorical response includes 4 ordered categories of response: <20%; 20% to <40%; 40% to <99%; ≥99%.
Measured: At both Week 20 and Week 24
Participants who achieve a reduction of at least 2 PS days per week from baseline at Week 24.
Measured: At Week 24
Participants who achieve a reduction of at least 3 PS days per week from baseline at Week 24.
Measured: At Week 24
Relative change from baseline in actual weekly PS volume at Week 12.
Measured: At Week 12
Relative change from baseline in parenteral nutrition (PN) calories at Week 24.
Measured: At Week 24
Improvement on Patient Global Impression of Change Version 2 (PGICv2) at Week 24.
Improvement defined as reporting "a little better" or "much better" on a 5-point scale.
Measured: At Week 24
Incidence of Treatment-Emergent Adverse Events
Measured: From first dose through 28 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel Syndrome (SBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VectivBio AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PSI CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742735
- Sponsor's protocol ID
- TA799-025
- Other IDs
- 2026-526274-16-00
- Acronym
- STARS-2
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided