STARS
CompletedPhase 3Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)
Lead sponsor
Asset
Apraglutide
Subcutaneous · GLP-2 receptor agonist
Listed sites
68
Recruiting sites
-
Actual enrollment
164
Study population
Gastrointestinal (gastroparesis / short bowel / pancreatitis)
Eligibility highlights
-
Primary endpoint
•Actual weekly PS volume
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Signed informed consent for this trial prior to any trial specific assessment.
2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
3. Subject must require PS at least 3 days per work and be considered stable.
4. No restorative surgery intended to change PS requirements in the trial period.
5. Age ≥18 years at screening.
Exclusion criteria
1. Pregnancy or lactation.
2. Major abdominal surgery in the last 6 months prior to screening.
3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
4. Evidence of active inflammatory GI conditions in the previous 6 months.
5. Evidence of decompensated heart failure.
6. Evidence of severe renal or hepatic impairment.
7. Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Patient-reported / QoL
3 endpointsChange from baseline on the Patient Global Impression of Treatment Satisfaction (PGI-TS) at week 24 and 48 (CIC only).
Time frame:Weeks 24 / 48 of treatment
change from baseline, improvement
Change from baseline on the Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Week 24 and 48 (CIC only).
Time frame:Weeks 24 / 48 of treatment
change from baseline, improvement
Change from baseline on the Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and 48 (CIC only).
Time frame:Weeks 24 / 48 of treatment
change from baseline, improvement
Safety / tolerability / PK
4 endpointsAbsorption rate constant (ka) of apraglutide through population PK data analysis
Time frame:Weeks 0 / 24 of treatment
descriptive
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Time frame:Weeks 0 / 24 of treatment
concentration, descriptive
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
Time frame:Weeks 0 / 24 of treatment
descriptive
Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only)
Time frame:Weeks 24 / 48 of treatment
concentration, descriptive
Other (unclassified)
9 endpointsRelative change from baseline in actual weekly PS volume at Week 24.
Time frame:At week 24 of treatment
percent change from baseline, improvement
Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only).
Time frame:Weeks 24 and 48 of treatment
threshold achievement, improvement
Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).
Time frame:Weeks 12 / 24 / 48 of treatment
percent change from baseline, improvement
Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).
Time frame:Weeks 24 / 48 of treatment
descriptive
At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
Time frame:Weeks 20 / 24 of treatment
threshold achievement, improvement
Calorie reduction in the PN at Weeks 24.
Time frame:Weeks 24 of treatment
change from baseline, improvement
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)
Time frame:Weeks 24 / 48 of treatment
change from baseline, improvement
Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)
Time frame:Weeks 24 / 48 of treatment.
change from baseline, improvement
At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only)
Time frame:Weeks 20 / 24 of treatment
threshold achievement, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.