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

NCT06512584 | Recruiting Phase 3 DMC

• 1 other identifier: CQPJ-PJ009-III
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 8

Brief 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 compare PJ009 to a placebo (a look-alike substance that contains no drug) to see if PJ009 works to treat SBS. 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.

Conditions

Short Bowel Syndrome

Keywords

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 20 to 24 of treatment period

Study Arms (2)

PJ009

EXPERIMENTAL

subcutaneous injections, 0.05 mg/kg once daily

Drug: PJ009

PJ009 Placebo

PLACEBO COMPARATOR

subcutaneous injections, once daily

Drug: PJ009 Placebo

Interventions

PJ009 DRUG

subcutaneous injections, 0.05 mg/kg once daily

Also known as: Glucagon-Like Peptide 2 (GLP-2) analogue

PJ009

PJ009 Placebo DRUG

subcutaneous injections, once daily

Also known as: GLP-2 analogue Placebo

PJ009 Placebo

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Chongqing Peg-Bio Biopharm Co., Ltd.: lead

Study Sites (8)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

NOT YET RECRUITING

Chongqing General Hospital

Chongqing, Chongqing Municipality, 401147, China

NOT YET RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

NOT YET RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hu'Nan, 410013, China

NOT YET RECRUITING

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, 210016, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

NOT YET RECRUITING

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Glucagon-Like Peptide 2

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Huanlong Qin

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Sun

CONTACT

86-13983367811; sunj@pegbiocq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: September 3, 2024
• Primary Completion: March 30, 2026
• Study Completion: April 27, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)