A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

NCT06973304 | Recruiting Phase 3

• 1 other identifier: TAK-633-3009
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Short Bowel Syndrome

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 and Maintained Through Week 24

  Up to Week 24

Secondary Outcomes (22)

• Absolute Change From Baseline in Weekly PS Volume up to Week 24

  Baseline up to Week 24

• Percent Change From Baseline in Weekly PS Volume up to Week 24

  Baseline up to Week 24

• Absolute Change From Baseline in Days Per Week of PS up to Week 24

  Baseline up to Week 24

• Percent Change From Baseline in Days Per Week of PS up to Week 24

  Baseline up to Week 24

• Number of Participants Who Achieved At Least 20% Reduction From Baseline in Weekly PS Volume at each visit

  Up to Week 24

Study Arms (1)

Teduglutide 0.05 milligram per kilogram (mg/kg)

EXPERIMENTAL

Participants will receive teduglutide 0.05 mg/kg subcutaneous (SC) injection, once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.

Drug: Teduglutide

Interventions

Teduglutide DRUG

Teduglutide 0.05 mg/kg SC injection.

Also known as: TAK-633, A16AX08, Revestive, Gattex

Teduglutide 0.05 milligram per kilogram (mg/kg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 18 years of age or older at the time of signing the informed consent.
• Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease).
• Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent.
• 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.
• Has a stable PS requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as follows:
• Actual PS usage is similar to prescribed PS.
• 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.
• 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.
• Participants with a history of Crohn's disease must be in endoscopic remission for at least 12 weeks prior to the baseline visit.

You may not qualify if:

• Pregnant or lactating female.
• 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.
• 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.
• Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit.
• Previous use of teduglutide.
• 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.
• Chronic intestinal pseudo-obstruction or severe dysmotility.
• 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.
• 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.
• Unstable cardiac disease, (example, congestive heart failure, cyanotic disease, or congenital heart disease).
• Moderate or severe renal impairment, defined as creatinine clearance less than 50 milliliters per minute (mL/min).
• Currently diagnosed with cancer or a history of any cancer except surgically cured skin cancer within the past 5 years.
• Severe hepatobiliary disease including any of the following:
• Total bilirubin level at least 2 times the upper limit of normal (ULN), except for increased indirect (unconjugated) bilirubin in a patient with Gilbert's syndrome.
• AST at least 5\*ULN.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Beijing Tsinghua Changgung Hospital

Changping, Beijing Municipality, 102218, China

RECRUITING

Peking Union Medical College Hospital

Dongcheng, Beijing Municipality, 100730, China

RECRUITING

Affiliated Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210016, China

RECRUITING

Zhongshan Hospital, Xiamen University

Siming, Xiamen, 361004, China

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

teduglutide; ALX-0600

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 15, 2025
• Study Start: June 26, 2025
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): July 28, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (4)