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New shot could cut IV feeding for short bowel patients

NCT ID NCT06512584

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

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

14 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Tsinghua Changgung Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 102218, China

  • Chongqing General Hospital

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, 401147, China

  • General Hospital of Eastern Theater Command

    RECRUITING

    Nanjing, Jiangsu, 210016, China

  • Shanghai Tenth People's Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200072, China

  • The Affiliated Hospital of Qingdao University

    NOT_YET_RECRUITING

    Qingdao, Shandong, 266000, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710061, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510655, China

  • The Third Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hu'Nan, 410013, China

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