STARSnutrition

CompletedPhase 2Results posted

Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)

A Multicenter, Open-label, Metabolic Balance Study to Evaluate the Effects of Apraglutide on Intestinal Absorption in Adult Subjects With Short Bowel Syndrome, Intestinal Failure (SBS-IF), and Colon-in-Continuity (CIC)

Lead sponsor

VectivBio AG

Asset

Apraglutide

Subcutaneous · GLP-2 receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Eligibility highlights

Primary endpoints

•Treatment-Emergent Adverse Event (TEAE)•Absorption of Energy Over Metabolic Balance (MB) Periods

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

NCT IDNCT04964986

Org study IDTA799-013

Secondary ID2020-005129-99

Timeline

Milestones

Study start2021-06-14actual

Study first posted2021-07-16actual

Primary completion2023-06-06actual

Study completion2023-06-06actual

Last update posted2025-06-18actual

Results first posted2025-06-18actual

Assets

Investigational agents

Apraglutide

Who this study enrolls

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Signed informed consent for this trial prior to any trial specific assessment.

•Male and female subjects with SBS-IF and CIC, receiving parenteral support (PS), secondary to surgical resection of the small intestine with < 200 cm from duodenojejunal flexure.

•Subject must require parenteral support (PS) at least 2 days per week and be considered stable.

•No restorative surgery intended to change PS requirements in the trial period.

•Age ≥ 18 years at screening.

Exclusion criteria

•Pregnancy or lactation.

•Body mass index equal or higher than 30 kg/m^2 at the time of screening.

•Major abdominal surgery in the last 6 months prior to screening.

Endpoints (40)

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

Other (unclassified)

Patient-reported / QoL

Safety / tolerability / PK

Other clinical outcomes

Patient-reported / QoL

6 endpoints

Secondary/protocol endpoint

Secondary: Patient Global Impression of Treatment Satisfaction (PGI-TS) at Week 24 and Week 52

Time frame:Week 24 and Week 52

descriptive

Secondary/registry result

Secondary: Patient Global Impression of Treatment Satisfaction (PGI-TS) at Week 24 and Week 52

Time frame:Week 24 and Week 52

descriptive

Posted result

Group	Participants	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	5	-
Week 24	3	-
Week 52	3	-
Week 52	6	-

Secondary/protocol endpoint

Change From Baseline in Patient Global Impression of Satisfaction With Parenteral Support (PGI-SPS) at Week 24 and Week 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Secondary/registry result

Change From Baseline in Patient Global Impression of Satisfaction With Parenteral Support (PGI-SPS) at Week 24 and Week 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Posted result

Group	Mean · score on a scale	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	-0.20	-
Week 52	0.00	-

Secondary/protocol endpoint

Change From Baseline in Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and Week 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Secondary/registry result

Change From Baseline in Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and Week 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Posted result

Group	Mean · score on a scale	95% CI
Apraglutide SC Injections, Once WeeklySleep Impact: Week 24	-0.40	-
Sleep Impact: Week 52	-0.50	-
Daily Activities Impact: Week 24	-0.80	-
Daily Activities Impact: Week 52	-1.00	-
QoL Impact: Week 24	-1.40	-
QoL Impact: Week 52	-1.25	-

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)

Time frame:Day 1 up to approximately 55 weeks

event count, event

Primary/registry result

Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)

Time frame:Day 1 up to approximately 55 weeks

event count, event

Posted result

Group	Participants	95% CI
Apraglutide SC Injections, Once WeeklyAt least one TEAE	9	-
At least one treatment-related TEAE	5	-
At least one TESAE	3	-
At least one treatment-related TESAE	1	-
At least one treatment-emergent AESI	3	-
At least one TEAE leading to dose interruption	1	-
At least one TEAE leading to permanent dose discontinuation	0	-

Secondary/protocol endpoint

Trough Apraglutide Plasma Concentration (Ctrough)

Time frame:Pre-dose on Weeks 2, 4, 12, 24, 32, 40, 48, and 52

concentration, descriptive

Secondary/registry result

Trough Apraglutide Plasma Concentration (Ctrough)

Time frame:Pre-dose on Weeks 2, 4, 12, 24, 32, 40, 48, and 52

concentration, descriptive

Posted result

Group	Mean · ng/mL	95% CI
Apraglutide SC Injections, Once WeeklyWeek 2	1.928	-
Week 4	1.217	-
Week 12	1.934	-
Week 24	2.863	-
Week 32	1.739	-
Week 40	2.386	-
Week 48	3.810	-
Week 52	2.678	-

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint

Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52

Time frame:Baseline, Week 24 and Week 52

threshold achievement, improvement

Secondary/registry result

Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52

Time frame:Baseline, Week 24 and Week 52

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	5	-
Week 52	7	-

Secondary/protocol endpoint

Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52

Time frame:Weeks 24 and 52

threshold achievement, improvement

Secondary/registry result

Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52

Time frame:Weeks 24 and 52

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	0	-
Week 52	2	-

Other (unclassified)

26 endpoints

Primary/protocol endpoint/low confidence

Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48

Time frame:Baseline and Week 48

change from baseline, improvement

Primary/registry result/low confidence

Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48

Time frame:Baseline and Week 48

change from baseline, improvement

Posted result

Group	Mean · kJ/day	95% CI
Apraglutide SC Injections, Once Weekly	1133.963	-

p0.041paired t-test

Secondary/protocol endpoint/low confidence

Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52

Time frame:Baseline, Week 4, Week 24, and Week 52

percent change from baseline, improvement

Secondary/registry result/low confidence

Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52

Time frame:Baseline, Week 4, Week 24, and Week 52

percent change from baseline, improvement

Posted result

Group	Mean · percentage change in PS volume	95% CI
Apraglutide SC Injections, Once WeeklyWeek 4	-0.73	-
Week 24	-39.99	-
Week 52	-52.44	-

Secondary/protocol endpoint/low confidence

Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Secondary/registry result/low confidence

Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Posted result

Group	Mean · mL	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	-3510.000	-
Week 52	-4701.778	-

p<0.001paired t-test

Week 24

p<0.001paired t-test

Week 52

Secondary/protocol endpoint/low confidence

Number of Participants Considered Clinical Responders at Weeks 24 and 52

Time frame:Baseline, Week 24 and 52

threshold achievement, improvement

Secondary/registry result/low confidence

Number of Participants Considered Clinical Responders at Weeks 24 and 52

Time frame:Baseline, Week 24 and 52

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	7	-
Week 52	9	-

Secondary/protocol endpoint/low confidence

Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Secondary/registry result/low confidence

Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Posted result

Group	Mean · kcal	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	-2763.889	-
Week 52	-3510.111	-

p0.002paired t-test

Week 24

p<0.001paired t-test

Week 52

Secondary/protocol endpoint/low confidence

Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48

Time frame:Baseline and Week 48

percent change from baseline, improvement

Secondary/registry result/low confidence

Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48

Time frame:Baseline and Week 48

percent change from baseline, improvement

Posted result

Group	Mean · percentage change	95% CI
Apraglutide SC Injections, Once Weekly	29.23	-

Secondary/protocol endpoint/low confidence

Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48

Time frame:Baseline, Week 4 and Week 48

change from baseline, improvement

Secondary/registry result/low confidence

Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48

Time frame:Baseline, Week 4 and Week 48

change from baseline, improvement

Posted result

Group	Mean · kJ/day	95% CI
Apraglutide SC Injections, Once WeeklyFat - Week 4	247.281	-
Fat - Week 48	406.741	-
Carbohydrate - Week 4	272.881	-
Carbohydrate - Week 48	877.011	-
Protein - Week 4	176.178	-
Protein - Week 48	194.400	-

p0.294paired t-test

Fat absorption increase at Week 4

p0.155paired t-test

Fat absorption increase at Week 48

p0.260paired t-test

Carbohydrate absorption at Week 4

p0.024paired t-test

Carbohydrate absorption at Week 48

p0.096paired t-test

Protein absorption at Week 4

p0.075paired t-test

Protein absorption at Week 48

Secondary/protocol endpoint/low confidence

Absolute Change in Urine Volume Over MB Periods From Baseline at Week 4 and Week 48

Time frame:Baseline, Week 4 and Week 48

change from baseline, improvement

Secondary/registry result/low confidence

Absolute Change in Urine Volume Over MB Periods From Baseline at Week 4 and Week 48

Time frame:Baseline, Week 4 and Week 48

change from baseline, improvement

Posted result

Group	Mean · mL/day	95% CI
Apraglutide SC Injections, Once WeeklyWeek 4	246.889	-
Week 48	-178.556	-

p0.063paired t-test

Week 4

p0.112paired t-test

Week 48

Secondary/protocol endpoint/low confidence

Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4

Time frame:Baseline and Week 4

change from baseline, improvement

Secondary/registry result/low confidence

Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4

Time frame:Baseline and Week 4

change from baseline, improvement

Posted result

Group	Mean · kJ/day	95% CI
Apraglutide SC Injections, Once Weekly	494.259	-

p0.306paired t-test

Secondary/protocol endpoint/low confidence

Absolute Change in Urinary Electrolytes Over MB Periods From Baseline at Week 4 and Week 48

Time frame:Baseline, Week 4 and Week 48

change from baseline, improvement

Secondary/registry result/low confidence

Absolute Change in Urinary Electrolytes Over MB Periods From Baseline at Week 4 and Week 48

Time frame:Baseline, Week 4 and Week 48

change from baseline, improvement

Posted result

Group	Mean · cmol/L	95% CI
Apraglutide SC Injections, Once WeeklyCalcium - Week 4	0.1444	-
Calcium - Week 48	-0.5532	-
Magnesium - Week 4	-0.258	-
Magnesium - Week 48	-2.306	-
Sodium - Week 4	31.668	-
Sodium - Week 48	17.097	-
Potassium - Week 4	2.047	-
Potassium - Week 48	-8.012	-
Urea - Week 4	7.693	-
Urea - Week 48	-89.649	-
Creatinine - Week 4	0.198	-
Creatinine - Week 48	-0.011	-

Median difference (final values)0.334695% CI-0.7887 - 0.8748p0.704paired t-test

Calcium, Week 4

Median difference (final values)-0.104095% CI-2.7442 - 0.8896p0.488paired t-test

Calcium, Week 48

Median difference (final values)-0.21995% CI-0.896 - 0.313p0.382paired t-test

Magnesium, Week 4

Median difference (final values)-1.56695% CI-5.279 - -0.165p0.059paired t-test

Magnesium, Week 48

Median difference (final values)33.11695% CI5.510 - 51.861p0.004paired t-test

Sodium, Week 4

Median difference (final values)20.72795% CI-27.758 - 55.828p0.337paired t-test

Sodium, Week 48

Median difference (final values)1.61895% CI-11.870 - 14.931p0.724paired t-test

Potassium, Week 4

Median difference (final values)-9.19095% CI-18.880 - 3.737p0.115paired t-test

Potassium, Week 48

Median difference (final values)12.29795% CI-39.551 - 52.617p0.707paired t-test

Urea, Week 4

Mean difference (final values)-91.48795% CI-159.956 - -20.068p0.009paired t-test

Urea, Week 48

Median difference (final values)0.28195% CI-0.649 - 0.960p0.572paired t-test

Creatinine, Week 4

Median difference (final values)-0.13695% CI-1.060 - 1.073p0.981paired t-test

Creatinine, Week 48

Secondary/protocol endpoint/low confidence

Change From Baseline in Pittsburgh Sleep Quality Inventory (PSQI) Total Score at Week 24 and Week 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Pittsburgh Sleep Quality Inventory (PSQI) Total Score at Week 24 and Week 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Posted result

Group	Mean · score on a scale	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	-1.89	-
Week 52	-1.56	-

p0.066paired t-test

Week 24

p0.015paired t-test

Week 52

Secondary/protocol endpoint/low confidence

Change From Baseline in Patient Global Impression of Change (PGIC) at Week 24 and Week 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Patient Global Impression of Change (PGIC) at Week 24 and Week 52

Time frame:Baseline, Week 24 and Week 52

change from baseline, improvement

Posted result

Group	Participants	95% CI
Apraglutide SC Injections, Once WeeklyWeek 24	6	-
Week 24	2	-
Week 52	8	-
Week 52	1	-

Secondary/protocol endpoint/low confidence

Mean Plasma Citrulline Level

Time frame:Baseline and Weeks 2, 4, 12, 24, 32, 40, 48, and 52

concentration, descriptive

Secondary/registry result/low confidence

Mean Plasma Citrulline Level

Time frame:Baseline and Weeks 2, 4, 12, 24, 32, 40, 48, and 52

concentration, descriptive

Posted result

Group	Mean · μmol/L	95% CI
Apraglutide SC Injections, Once WeeklyBaseline	11.571	-
Week 2	13.516	-
Week 4	15.531	-
Week 12	14.860	-
Week 24	14.810	-
Week 32	14.994	-
Week 40	17.860	-
Week 48	16.638	-
Week 52	14.714	-

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.