What is PJ009 studying for short bowel syndrome?

PJ009 is being studied to understand its effectiveness and safety in treating patients with short bowel syndrome who need parenteral nutrition. This clinical trial compares PJ009 to a placebo to see if it can improve patient outcomes. The research is sponsored by Chongqing Peg-Bio Biopharm Co., Ltd.

Who may be eligible for this short bowel syndrome clinical trial?

Individuals aged 14 years or older with short bowel syndrome requiring regular parenteral nutrition may be eligible. Participants must be on stable nutrition support and able to consent to the study. People with active inflammatory bowel diseases or recent use of certain related drugs are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this short bowel syndrome clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 14Years +

All Genders

ID06512584

Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study

Led by Chongqing Peg-Bio Biopharm Co., Ltd. · Updated on 2026-03-02

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of PJ009 in treating patients aged 14 and older with short bowel syndrome SBS who require parenteral nutrition. This randomized, double-blind, placebo-controlled Phase 3 study aims to determine if PJ009 can improve outcomes compared to a placebo. The study also assesses immunogenicity and pharmacokinetics of PJ009 in these patients. Participants will receive daily subcutaneous injections of PJ009 or a placebo based on their weight for 24 weeks. After this period, those who received placebo will switch to PJ009 for an additional 12 weeks, while those on PJ009 will continue the same treatment until the end of 36 weeks. The trial includes a screening, optimization, and stabilization period lasting up to 16 weeks before treatment begins, followed by the double-blind treatment and an open-label extension phase. During the study, participants will visit the clinic at scheduled times including weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, and 36 for assessments. They will keep a diary tracking their parenteral nutrition, enteral nutrition, and urine output. Researchers will measure the percentage of responders between weeks 20 and 24 to evaluate treatment effect. Safety follow-ups will be conducted four weeks after the last dose to monitor participants health throughout the study.

CONDITIONS

Brief Title

Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition

Who Can Participate

Age: 14Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male and female aged 14 years or older
Short bowel syndrome patients dependent on parenteral nutrition or intravenous support for at least 6 consecutive months due to major intestinal resection
At least 3 parenteral nutrition or intravenous support sessions per week within 1 week before screening or 2 weeks before baseline
Stable parenteral nutrition or intravenous support for at least 4 consecutive weeks before treatment
For those with a history of Crohn's disease, clinical remission for at least 12 weeks before treatment
Ability to understand and provide signed informed consent; for those under 18, guardian consent is also required
Ability to complete study procedures following the protocol

You will not qualify if you...

Prior use of teduglutide or allergy to teduglutide or its components
Use of natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening
Use of glutamine, octreotide, GLP-1 analogs, or dipeptidyl peptidase-IV inhibitors within 30 days before screening
Active Crohn's disease or need to change biological therapy within 6 months before screening
Active inflammatory bowel disease or recent changes in immunosuppressant therapy within 3 months
Unstable absorption due to cystic fibrosis, untreated megacolon, or known DNA abnormalities like familial adenomatous polyposis or Fanconi syndrome
Clinically obvious intestinal obstruction or active stenosis within 6 months before screening
Major gastrointestinal surgery within 3 months before screening (except minor procedures like esophageal intubation or endoscopic surgery)
Severe active, uncontrolled systemic diseases including cardiovascular, respiratory, renal, infectious, endocrine, liver, or central nervous system diseases
Malignant tumors within 5 years before screening, except certain fully treated localized cancers
Severe liver function impairment as defined by specific lab values
Renal function impairment as defined by specific lab values
Pancreatic abnormalities with elevated serum amylase or lipase
More than 4 hospitalizations related to SBS or parenteral nutrition within 12 months before screening
Unplanned hospitalization within 30 days before screening
Pregnant or lactating women, or those planning fertility without effective contraception
Participation in other clinical trials within specified timeframes before screening
Other conditions deemed unsuitable by the investigator for study participation

Research Team

Jing Sun

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