NCT06512584

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	PJ009	subcutaneous injections, 0.05 mg/kg once daily
DRUG	PJ009 Placebo	subcutaneous injections, once daily

Timeline

• Start date: 2024-09-03
• Primary completion: 2026-03-30
• Completion: 2026-04-27
• First posted: 2024-07-22
• Last updated: 2026-03-02

Locations

8 sites across 1 country: China