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RECRUITINGPHASE3

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg/kg/Day Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support

NCT06973304•Takeda

View on ClinicalTrials.gov

Summary

The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral support and understand how the body absorbs, processes, and gets rid of teduglutide. Participants will receive a daily injection of teduglutide under the skin for 24 weeks. Safety of teduglutide will be checked for 24 weeks after treatment. Participants will be in the study for about 65 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females 18 years of age or older at the time of signing the informed consent.
•2. Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease).
•3. Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent.
•4. Requires PS at least 3 times per week or at least 4 liters per week during the 2 weeks prior to baseline to meet caloric, fluid, or electrolyte needs due to ongoing malabsorption.
•5. Has a stable PS requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as follows:
•1. Actual PS usage is similar to prescribed PS.
•2. Baseline (Visit 2) 48-hour intake (I)/output (O) volumes should fall within +-25% of the respective 48-hour I/O volumes at the last optimization visit.
•3. The 48-hour urine output volume must not be less than 2 liters and should not exceed 4 liters at the last optimization visit, the stabilization visit, and the baseline visit.
•6. Participants with a history of Crohn's disease must be in endoscopic remission for at least 12 weeks prior to the baseline visit.

Exclusion Criteria

•1. Pregnant or lactating female.
•2. Participation in a clinical study using an experimental drug within 30 days or 5 half-lives, whichever is longer, prior to screening, or concurrent participation in any other clinical study.
•3. Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months prior to the baseline visit.
•4. Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit.
•5. Previous use of teduglutide.
•6. Active inflammatory bowel disease (IBD) or any participant with IBD requiring immunosuppressant therapy (example, azathioprine,anti-tumor necrosis factor \[anti-TNF\]) drugs) that had been introduced or changed within the past 6 months prior to the baseline visit.
•7. Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, familial adenomatous polyposis.
•8. Chronic intestinal pseudo-obstruction or severe dysmotility.
•9. Clinically significant intestinal stenosis or obstruction, or evidence of such on upper gastrointestinal (UGI)/small bowel follow-through (SBFT), within the past 6 months prior to the baseline visit.
•10. Major gastrointestinal (GI) surgical intervention, including significant intestinal resection, within the past 3 months (insertion of feeding tube, anastomotic ulcer repair, minor intestinal resections less than or equal to \[\<=\] 10 centimeter \[cm\], or endoscopic procedure is allowed) prior to the baseline visit.
+15 more criteria

Locations (4)

Beijing Tsinghua Changgung Hospital

Changping, Beijing Municipality, China

Peking Union Medical College Hospital

Dongcheng, Beijing Municipality, China

Affiliated Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Zhongshan Hospital, Xiamen University

Siming, Xiamen, China

Key Dates

Start Date

June 26, 2025

Primary Completion Date

February 10, 2027

Completion Date

July 28, 2027

Last Updated

July 9, 2025

Enrollment

ESTIMATED participants

Conditions

Short Bowel Syndrome

Interventions

Teduglutide

DRUG

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

Inclusion Criteria

Exclusion Criteria

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Registry for Participants With Short Bowel Syndrome

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF