New drug could cut IV nutrition needs for short bowel patients
NCT ID NCT06973304
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This phase 3 trial tests a drug called teduglutide in 13 Chinese adults with short bowel syndrome who rely on IV nutrition. Participants get a daily injection for 24 weeks to see if it reduces their need for IV support. The study also checks safety and how the body processes the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- teduglutide (a drug that helps the intestines absorb more nutrients)
- What this could lead to
- If it works, this could help people with short bowel syndrome reduce their dependence on intravenous nutrition, improving daily life.
- What could go wrong
- This is a small, early-phase trial with only 13 participants, so results may not apply to everyone. The drug may not work as hoped, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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13 people
The number who actually took part.
- Started
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Jun 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 11. Unstable cardiac disease, (example, congestive heart failure, cyanotic disease, or congenital heart disease). 12. Moderate or severe renal impairment, defined as creatinine clearance less than 50 milliliters per minute (mL/min). 13. Currently diagnosed with cancer or a history of any cancer except surgically cured skin cancer within the past 5 years. 14. Severe hepatobiliary disease including any of the following: 1. 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. 2. AST at least 5\*ULN. 3. ALT at least 5\*ULN 15. Active clinically significant pancreatic disease, including clinical signs of pancreatitis associated with elevations in serum amylase or lipase at least 2\*ULN. 16. More than 4 SBS-related or PS-related hospital admissions (example, central line-associated bloodstream infection, bowel obstruction, severe fluid/electrolyte disturbances) within the past 12 months prior to the baseline visit. 17. Unscheduled hospitalization within 30 days prior to screening. 18. Non-herpetic viral diseases: 1. Presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (ribonucleic acid) (nucleic acid test or polymerase chain reaction). 2. Presence of (Hepatitis B Surface Antigen Positive \[HBsAg+\]). For participants who are negative for HBsAg but are positive for either surface antibodies and/or core antibodies, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction will be performed; if any test result meets or exceeds detection sensitivity, the subject will be excluded. 3. Positive results for human immunodeficiency virus (HIV) by serology, regardless of viral load. 19. Any condition, disease, illness, or circumstance that in the investigator's opinion puts the participant at any undue risk, prevents completion of the study, or interferes with analysis of the study results. Example of potential disease state/illnesses that may be excluded are listed in the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210016, China
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Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, 102218, China
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Peking Union Medical College Hospital
Dongcheng, Beijing Municipality, 100730, China
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Zhongshan Hospital, Xiamen University
Siming, Xiamen, 361004, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an amino acid pill help the body build protein when the gut fails?
- Measuring hidden energy needs: a clue to better nutrition for gut failure patients
- Weekly shot could help people with short bowel syndrome absorb more fluids
- Could a Plant-Based powder cut the need for IV nutrition?
- Growth hormone shows promise for weaning kids off IV nutrition
- New drug teduglutide monitored in 250 patients with short bowel syndrome