New shot could cut IV feeding for short bowel patients
NCT ID NCT06512584
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called PJ009 in people aged 14 and older with short bowel syndrome who rely on IV nutrition. The goal is to see if daily shots can safely reduce the amount of IV nutrition needed. Participants will receive either PJ009 or a placebo for 24 weeks, then all will get PJ009 for 12 more weeks. The study tracks changes in IV nutrition volume and safety.
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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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Apr 2026
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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14 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. Male and female aged ≥ 14 years; 2. SBS patients dependent on PN/IV support for at least 6 consecutive months due to major intestinal resection; 3. At least 3 PN/IV support sessions per week are required 1 week before screening or 2 weeks before baseline; 4. Be on stable PN/IV support for at least 4 consecutive weeks before administration; 5. For subjects with a history of Crohn's disease (CD), clinical assessment of remission for at least 12 weeks prior to administration; 6. Be able to understand and provide signed informed consent, for those under 18 years old, the guardian should also sign the informed consent; 7. Be able to complete experiments in accordance with the protocol. Exclusion Criteria: 1. Have used teduglutide in the past or may be allergic to teduglutide or its components; 2. Have used natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening; 3. Have used glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitors within 30 days before screening; 4. With active Crohn's disease or those who need to change biological therapy within 6 months before screening; 5. With active inflammatory bowel disease (IBD) or IBD patients who have received immunosuppressant therapy changes in the past 3 months; 6. With unstable absorption due to cystic fibrosis, untreated megacolon disease or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome); 7. With clinically obvious intestinal obstruction or active stenosis within 6 months before screening; 8. Have undergone major gastrointestinal surgical intervention within 3 months before screening, such as continuous transverse enteroplasty or other intestinal lengthening surgery (esophageal intubation or endoscopic surgery is allowed); 9. Severe active, uncontrolled, untreated systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system diseases, etc.); 10. Have malignant tumors within 5 years before screening (except for fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery); 11. With severe liver function impairment: 1. Total bilirubin ≥ 2.0 × upper limit of normal (ULN); for patients with Gilbert's syndrome, direct bilirubin ≥ 2.0 × ULN; 2. Aspartate transaminase (AST) ≥ 5.0 × ULN, alanine transaminase (ALT) ≥5.0 × ULN; 12. With renal function impairment: 1. Serum creatinine ≥2.0 × ULN; 2. Creatinine clearance \< 60 ml/min (calculated according to the Cockcroft-Gault formula, see Appendix 3 for details); 13. Pancreatic abnormalities: 1. Serum amylase ≥ 2.0 × ULN; 2. Serum lipase ≥ 2.0 × ULN; 14. More than 4 SBS or PN-related hospitalizations (such as catheter sepsis, intestinal obstruction, severe water and electrolyte disorders) within 12 months before screening; 15. Unplanned hospitalization within 30 days before screening; 16. Pregnant or lactating women, women or men who have fertility plans or do not agree to take effective contraceptive measures during the trial; 17. Participated in any clinical trial (excluding antibody treatment-related clinical trials) within 30 days before screening or participated in any antibody treatment-related clinical trials within 3 months before screening; 18. Other condition the investigator believes would be unsuitable for participation in this clinical study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tsinghua Changgung Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 102218, China
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Chongqing General Hospital
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 401147, China
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General Hospital of Eastern Theater Command
RECRUITINGNanjing, Jiangsu, 210016, China
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Shanghai Tenth People's Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200072, China
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The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITINGQingdao, Shandong, 266000, China
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The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi’an, Shanxi, 710061, China
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The Sixth Affiliated Hospital of Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510655, China
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The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITINGChangsha, Hu'Nan, 410013, 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
- New drug could cut IV nutrition needs for short bowel patients
- Could a Plant-Based powder cut the need for IV nutrition?
- Growth hormone shows promise for weaning kids off IV nutrition