Efficacy and Safety of apraglutide in short bowel syndrome and intestinal failure

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) - Efficacy and Safety of apraglutide in SBS-IF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001202-32-DE

Enrollment

164

Registered

2020-08-04

Start date

2020-11-02

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

short bowel syndrome and intestinal failure MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: apraglutide Product Code: TA799 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: APRAGLUTIDE CAS Number: 1295353-98-8 Current Sponsor code: TA799

FE 203799 Other descriptive name: apraglutide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Powder for solution for inject

Eligibility

Sex/Gender

All

Inclusion criteria

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 week and be considered stable. 4. No planned restorative surgery or major intestinal surgery (more than 10% intestinal resection or surgery that changes anatomy group i.e. stoma or CIC), in the trial period. 5. Age =18 years at Screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 52

Exclusion criteria

Exclusion criteria: 1.Pregnancy and/or lactation. 2.Major abdominal surgery in the last 6 months prior to screening visit. 3.History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within =5 years, except for adequately treated basal cell skin cancer. 4.Active inflammatory bowel disease (IBD) or underlying condition that requires new drug treatment or regimen changes in the previous 3 months. 5.Evidence of decompensated heart failure. 6.Evidence of severe renal or hepatic impairment. 7.Any treatment of greater than 2 weeks of growth factors such as growth hormone (GH), native GLP-2, GLP-1, short acting GLP-2 analogues (e.g., teduglutide) or GLP-1 analogues in the previous 3 months before randomization or treatment with longer acting experimental GLP-2 analogues should be discussed with the Investigator.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of weekly SC apraglutide in reducing parenteral support dependency;Secondary Objective: To evaluate selected parameters indicative of clinical efficacy • To evaluate the safety and tolerability of apraglutide compared with placebo • To assess the PK of apraglutide;Primary end point(s): Relative change from baseline in actual weekly PS volume at Week 24.;Timepoint(s) of evaluation of this end point: week 24	—

Measure

Time frame

Main Objective: To evaluate the efficacy of weekly SC apraglutide in reducing parenteral support dependency;Secondary Objective: To evaluate selected parameters indicative of clinical efficacy • To evaluate the safety and tolerability of apraglutide compared with placebo • To assess the PK of apraglutide;Primary end point(s): Relative change from baseline in actual weekly PS volume at Week 24.;Timepoint(s) of evaluation of this end point: week 24

—

Secondary

Measure	Time frame
Secondary end point(s): •Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Weeks 24 / 48. •Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48. •SBS-IF patients reaching enteral autonomy at Weeks 24 / 48. •At least 20% reduction of PS volume from baseline at Weeks 20 / 24. •Calorie reduction from baseline in the PN at Weeks 24. •Change from baseline on QoL measures at Weeks 24 / 48. •Apraglutide PK parameters (baseline through Week 48). ;Timepoint(s) of evaluation of this end point: specified at point E.5.2	—

Measure

Time frame

Secondary end point(s): •Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Weeks 24 / 48. •Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48. •SBS-IF patients reaching enteral autonomy at Weeks 24 / 48. •At least 20% reduction of PS volume from baseline at Weeks 20 / 24. •Calorie reduction from baseline in the PN at Weeks 24. •Change from baseline on QoL measures at Weeks 24 / 48. •Apraglutide PK parameters (baseline through Week 48). ;Timepoint(s) of evaluation of this end point: specified at point E.5.2

—

Countries

Argentina, Belgium, Czechia, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Norway, Poland, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

Public ContactClinical Trial Information Desk

VectivBio AG

clinicaltrial.enquiries@vectivbio.com+41 44 660 6590

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026