Short Bowel SyndromePhase 3NCT06512584
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
A Phase 3 study testing PJ009 in people with Short Bowel Syndrome, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 8 sites in China.
Trial summary
The main aim of this clinical trial is to assess the efficacy and safety of PJ009 in patients aged ≥14 with short bowel syndrome (SBS) requiring parenteral nutrition. The main questions it aims to answer are: How effective is PJ009 in treating short bowel syndrome? Is PJ009 safe in these patients? Researchers will… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- PJ009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 8 sitesChina
- Study dates
- 3 Sep 2024to 15 Mar 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female aged ≥ 14 years;
- SBS patients dependent on PN/IV support for at least 6 consecutive months due to major intestinal resection;
- At least 3 PN/IV support sessions per week are required 1 week before screening or 2 weeks before baseline;
- Be on stable PN/IV support for at least 4 consecutive weeks before administration;
- For subjects with a history of Crohn's disease (CD), clinical assessment of remission for at least 12 weeks prior to administration;
- Be able to understand and provide signed informed consent, for those under 18 years old, the guardian should also sign the informed consent;
- Be able to complete experiments in accordance with the protocol.
Who cannot join
- Have used teduglutide in the past or may be allergic to teduglutide or its components;
- Have used natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening;
- Have used glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitors within 30 days before screening;
- With active Crohn's disease or those who need to change biological therapy within 6 months before screening;
- With active inflammatory bowel disease (IBD) or IBD patients who have received immunosuppressant therapy changes in the past 3 months;
- With unstable absorption due to cystic fibrosis, untreated megacolon disease or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome);
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- With clinically obvious intestinal obstruction or active stenosis within 6 months before screening;
- 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);
- Severe active, uncontrolled, untreated systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system diseases, etc.);
- 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);
- With severe liver function impairment:
- Total bilirubin ≥ 2.0 × upper limit of normal (ULN); for patients with Gilbert's syndrome, direct bilirubin ≥ 2.0 × ULN;
- Aspartate transaminase (AST) ≥ 5.0 × ULN, alanine transaminase (ALT) ≥5.0 × ULN;
- With renal function impairment:
- Serum creatinine ≥2.0 × ULN;
- Creatinine clearance < 60 ml/min (calculated according to the Cockcroft-Gault formula, see Appendix 3 for details);
- Pancreatic abnormalities:
- Serum amylase ≥ 2.0 × ULN;
- Serum lipase ≥ 2.0 × ULN;
- More than 4 SBS or PN-related hospitalizations (such as catheter sepsis, intestinal obstruction, severe water and electrolyte disorders) within 12 months before screening;
- Unplanned hospitalization within 30 days before screening;
- Pregnant or lactating women, women or men who have fertility plans or do not agree to take effective contraceptive measures during the trial;
- 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;
- Other condition the investigator believes would be unsuitable for participation in this clinical study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
The Third Xiangya Hospital of Central South University
Changsha, Hu'Nan, 410013
Chongqing General Hospital
Chongqing, Chongqing Municipality, 401147
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210016
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
The main aim of this clinical trial is to assess the efficacy and safety of PJ009 in patients aged ≥14 with short bowel syndrome (SBS) requiring parenteral nutrition. The main questions it aims to answer are:
- How effective is PJ009 in treating short bowel syndrome?
- Is PJ009 safe in these patients? Researchers will compare PJ009 to a placebo (a look-alike substance that contains no drug) to see if PJ009 works to treat SBS.
Read more
Participants will
- Receive daily subcutaneous injections of PJ009 or placebo according to weight for 24 weeks, and then the participants receive placebo will be switched to receive PJ009 for another 12 weeks, while participants receive PJ009 continued the same treatment until the end of 36 weeks,
- Visit the clinic at the end of week 1(w1), w2, w4, w8, w12, w16, w20, w24, w30 and w36 for assessment,
- Keep a diary of the amount of their parenteral nutrition/ intravenous fluids (PN/IV), enteral nutrition and urine volume.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled clinical study, aiming to evaluate the efficacy, safety, immunogenicity and pharmacokinetic of PJ009 in patients with short bowel syndrome requiring parenteral nutrition, using placebo as a control.
The trial is divided into 3 periods. Period 1 of this trial is the screening, optimization (if applicable, up to 8 weeks) and stabilization (4-8 weeks) period. At the end of the stabilization period, a baseline enrollment evaluation will be performed, and all eligible participants will enter the 24 weeks of double-blind treatment period (period 2). Period 3 is a 12-week open label extension to period 2. Safety follow-up assessments will be performed 4 weeks after the last dose in treatment period 3.
- Conditions
- Short Bowel Syndrome
- Being tested
- PJ009, PJ009 Placebo
- Keywords
- Short Bowel Syndrome
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PJ009Drug
Also called Glucagon-Like Peptide 2 (GLP-2) analogue
subcutaneous injections, 0.05 mg/kg once daily
PJ009 PlaceboDrug
Also called GLP-2 analogue Placebo
subcutaneous injections, once daily
| Study group | Role | What they receive |
|---|---|---|
| PJ009 | Experimental | subcutaneous injections, 0.05 mg/kg once daily Receives: Drug: PJ009 |
| PJ009 Placebo | Placebo comparator | subcutaneous injections, once daily Receives: Drug: PJ009 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of responders
A responder's PN/IV volume per week shows a reduction of at least 20% from baseline from week 20 to 24 in treatment period.
Measured: Week 20 to 24 of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start3 Sep 2024
- Primary completion28 Sep 2026
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huanlong Qin, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512584
- Sponsor's protocol ID
- CQPJ-PJ009-III
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No