Phase 2
N=9
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
Short Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04964986 ↗Enrolled (actual)
9
Serious AEs
33.3%
Results posted
Jun 2025
Primary outcome: Primary: Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) — 9; 5; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Apraglutide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VectivBio AG
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) |
9; 5; 3; 1; 3; 1 | — |
| PRIMARY Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48 |
1133.963 | 0.041 sig |
| SECONDARY Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52 |
-0.73; -39.99; -52.44 | — |
| SECONDARY Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52 |
-3510.000; -4701.778 | <0.001 sig |
| SECONDARY Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52 |
5; 7 | — |
| SECONDARY Number of Participants Considered Clinical Responders at Weeks 24 and 52 |
7; 9 | — |
| SECONDARY Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52 |
0; 2 | — |
| SECONDARY Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52 |
-2763.889; -3510.111 | 0.002 sig |
| SECONDARY Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48 |
29.23 | — |
| SECONDARY Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48 |
247.281; 406.741; 272.881; 877.011; 176.178; 194.400 | 0.294 |
| SECONDARY Absolute Change in Urine Volume Over MB Periods From Baseline at Week 4 and Week 48 |
246.889; -178.556 | 0.063 |
| SECONDARY Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4 |
494.259 | 0.306 |
| SECONDARY Absolute Change in Urinary Electrolytes Over MB Periods From Baseline at Week 4 and Week 48 |
0.1444; -0.5532; -0.258; -2.306; 31.668; 17.097 | 0.704 |
| SECONDARY Change From Baseline in Pittsburgh Sleep Quality Inventory (PSQI) Total Score at Week 24 and Week 52 |
-1.89; -1.56 | 0.066 |
| SECONDARY Change From Baseline in Patient Global Impression of Change (PGIC) at Week 24 and Week 52 |
6; 2; 8; 1 | — |
| SECONDARY Secondary: Patient Global Impression of Treatment Satisfaction (PGI-TS) at Week 24 and Week 52 |
5; 3; 3; 6 | — |
| SECONDARY Change From Baseline in Patient Global Impression of Satisfaction With Parenteral Support (PGI-SPS) at Week 24 and Week 52 |
-0.20; 0.00 | — |
| SECONDARY Change From Baseline in Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and Week 52 |
-0.40; -0.50; -0.80; -1.00; -1.40; -1.25 | — |
| SECONDARY Trough Apraglutide Plasma Concentration (Ctrough) |
1.928; 1.217; 1.934; 2.863; 1.739; 2.386 | — |
| SECONDARY Mean Plasma Citrulline Level |
11.571; 13.516; 15.531; 14.860; 14.810; 14.994 | — |
Summary
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04964986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.