DRUG
teduglutide
0.05 mg/kg/day sc injection for 24 weeks
Status
Completed
Phase
Phase 3
Enrollment
86
Locations
35
Results
Posted
Publications
8
Study summary
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.
Interventions
DRUG
0.05 mg/kg/day sc injection for 24 weeks
DRUG
Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks
Timeline
First posted
Nov 27, 2008
Study start
Nov 25, 2008
Primary completion
Jan 25, 2011
Study completion
Jan 25, 2011
Results posted
Feb 1, 2012
Registry updated
Jun 3, 2021
Outcomes
Responder
Time frame · Weeks 20 and 24
Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.
Absolute Change in PN/I.V. Volume From Baseline to Last Time Point
Time frame · Week 0 to last visit when data was collected.
Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).
Eligibility
Inclusion Criteria: * Signed and dated informed consent prior to any study-related procedures are performed * Men and women 18 years of age or older at the time of informed consent signing * Intestinal failure resulting in Short Bowel Syndrome * At least 12 months of continuous PN dependency * 12 weeks of clinical remission of Crohn's disease (CD) prior to dosing * PN required at least 3 times weekly * A stable PN volume for four weeks prior to dosing Exclusion Criteria: * History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state * Participation in clinical study within 30 days for drug or 90 days for antibody * Use of native GLP-2 or human growth hormone (HGH) within 6 months of screening * Use of iv glutamine within 30 days prior to screening * Use of teduglutide * CD patients who have been treated with biological therapy within 6 months of screening * IBD patients who require chronic systemic immunosuppressant therapy * More than 4 SBS- or PN-related hospitalizations within 12 months of screening * Unplanned hospitalization within one month of screening * Pregnant or lactating women * Body weight \> 88kg * Body mass index (BMI) \< 15 kg/m2 * Severe hepatic impairment or disturbed renal function * Female subjects who are not surgically sterile or postmenopausal or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period * Not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements * Any condition or circumstance that is the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with the analysis of the study results * Significant active, uncontrolled, untreated systemic diseases
Study locations
Canada · Denmark · France · Germany · Italy · Netherlands · Poland · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Scripps Clinic & Research Foundation
La Jolla, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Mount Sinai Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Critical Care Research, Royal Alexandra Hospital
Edmonton, Alberta, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Polyclinic Family and Specialty Medicine Facility
North York, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A
Copenhagen, Denmark
Hôpital Beaujon
Clichy, France
Hôpital Croix Rousse Unité de Nutrition Clinique Intensive
Lyon, France
Hôpital de l'Archet Pôle Digestif
Nice, France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Israelitisches Krankenhaus
Hamburg, Free and Hanseatic City of Hamburg, Germany
Med. Klinik m.S. Hepatologie und Gastroenterologie
Berlin, State of Berlin, Germany
Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette
Torino, TO, Italy
Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale
Bologna, Italy
Publications
Related trials
Takeda · Short Bowel Syndrome
Phase 3
Recruiting
13
2026-06
International Centre for Diarrhoeal Disease Research, Bangladesh · Environmental Enteric Dysfunction
Phase 2
Not yet recruiting
55
2026-04
Takeda · Short Bowel Syndrome
Not applicable
Active, not recruiting
250
2026-04
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
12
2026-03
Meyer Children's Hospital IRCCS · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
50
2026-02
Takeda · Short Bowel Syndrome (SBS)
Not applicable
Recruiting
600
2026-01
Shire · Short Bowel Syndrome
Not applicable
Active, not recruiting
1,806
2025-10
Assistance Publique - Hôpitaux de Paris · Short Bowel Syndrome
Phase 4
Completed
25
2025-09
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.