Short Bowel SyndromePhase 2NCT07704047
A Clinical Study of FT1 in Patients With Short Bowel Syndrome
A Phase 2 study testing FT1 in people with Short Bowel Syndrome and SBS, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if FT1 is safe and works to treat short bowel syndrome (SBS) in adults. It will also learn about the PK/PD profile of FT1. Researchers will compare FT1 to a placebo (a look-alike substance that contains no drug) to see if FT1 is safe and effective in patients with SBS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome, SBS
- What is being tested?
- FT1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 15 Apr 2027
- Phase
- Phase 2
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female.
- SBS secondary to surgical resection of the small intestine, screened for at least 12 months after pre intestinal resection surgery;
- Stable weight before screening; For patients requiring parenteral support (PS), PS volume remained stable (with changes in volume or energy content<25%) within 14 days prior to randomization;
- Willing to undergo colonoscopy and remove polyps assessed by researchers to be at risk of cancer;
- During the trial period, there were no plans to perform any major abdominal surgeries (such as intestinal resection exceeding 10% or surgeries that alter intestinal anatomy, such as stoma surgery);
- During the baseline metabolic balance study, the average daily fecal wet rearrangement amount was ≥ 800g;
Who cannot join
- Having undergone major abdominal surgery (such as intestinal resection exceeding 10%) within the past 6 months prior to screening;
- History of clinically significant intestinal adhesions and/or chronic abdominal pain;
- History of persistent radiation enteritis, celiac disease, refractory diarrhea, etc;
- Patients with malignant tumors within the past 5 years (excluding fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery);
- History of gallstones in the past 3 years, except for those who have undergone cholecystectomy for gallstones; Acute cholecystitis or biliary obstruction related diseases that have not been treated within the previous month or during the screening period;
- IBD patients with active inflammatory bowel disease (IBD), or requiring increased or altered immunosuppressive therapy in the past 3 months, or receiving biologic therapy in the past 6 months;
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- Occurrence of central venous catheter-related bloodstream infections within 2 months prior to and during the screening period;
- Patients diagnosed with decompensated heart failure (NYHA grade III or above) and/or unstable angina and/or myocardial infarction from 6 months prior to screening until the first administration of the study drug;
- Screening for individuals with rectal bleeding within the first 3 months;
- Individuals with absorption instability caused by cystic fibrosis, untreated megacolon disease, or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome);
- Serious active, uncontrolled, untreated, acute onset systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system, etc.);
- Pregnant or breastfeeding women.
- The investigator believes the subject is unsuitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002
Xinying Wang, 86-13983367811, sunj@pegbiocq.com
Xinying Wang
About this study
Official title: A Randomized, Double-blind, Crossover, Placebo-controlled Phase IIa Clinical Study Evaluating the Efficacy and Safety of Recombinant Acylated Glucagon Like Peptide-2 Analog (FT1) for Injection in Patients With Short Bowel Syndrome
The goal of this clinical trial is to learn if FT1 is safe and works to treat short bowel syndrome (SBS) in adults. It will also learn about the PK/PD profile of FT1.
Researchers will compare FT1 to a placebo (a look-alike substance that contains no drug) to see if FT1 is safe and effective in patients with SBS.
Participants will
- Receive multiple injections of FT1 or placebo according to weight.
- Visit the clinic for assessment.
Read the detailed description
In this placebo-controlled, double-blind, randomized, crossover phase 2 trial, 8 adult SBS patients are treated with once-weekly FT1 or placebo (1:1) for 5 weeks, followed by a washout period of at least 6 weeks, and then the alternate treatment for a further 5 weeks.
Efficacy is evaluated through a 72 hour metabolic balance study conducted at baseline and at the end of each treatment cycle.
- Conditions
- Short Bowel Syndrome, SBS
- Being tested
- FT1, Placebo
- Keywords
- short bowel syndrome, SBS, GLP-2, FT1
- 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.
FT1Drug
FT1 treatment, once weekly for 5 weeks
PlaceboDrug
Placebo, once weekly for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| FT1 | Experimental | FT1 will be administered subcutaneously once a week for 5 weeks during each treatment cycle. Receives: Drug: FT1 |
| FT1 Placebo | Placebo comparator | FT1 Placebo will be administered subcutaneously once a week for 5 weeks during each treatment cycle. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events
To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, timing, seriousness, and relationship to study therapy after administration.
Measured: From the first administration to study completion, appropriately 5 months.
Changes in fecal wet weight from baseline to the end of treatment
The difference in changes in fecal wet weight in the 72-hour metabolic balance study after treatment compared to baseline
Measured: At the end of the second cycle (each cycle is 5 weeks, with a washout period of at least 6 weeks between two cycles)
Secondary outcomes (4)
Changes in urine volume from baseline to the end of treatment
The difference in changes in urine volume in the 72-hour metabolic balance study after treatment compared to baseline
Measured: At the end of the second cycle (each cycle is 5 weeks, with a washout period of at least 6 weeks between two cycles)
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Pharmacokinetic parameter
Measured: Up to 8 days, from Day 29 (the last dose administration) to Day 36 (7 days after the last dose) in each treatment cycle (each cycle is 5 weeks)
Maximum plasma concentration (Cmax)
Pharmacokinetic parameter
Measured: Up to 8 days, from Day 29 (the last dose administration) to Day 36 (7 days after the last dose) in each treatment cycle (each cycle is 5 weeks)
Changes in L-citrulline levels in plasma
Pharmacodynamic parameter
Measured: From Day 1 of the first cycle to the end of the second cycle (each cycle is 5 weeks, with a washout period of at least 6 weeks between two cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start30 Aug 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this placebo-controlled, double-blind, randomized, crossover trial, SBS patients are treated with once-weekly FT1 or placebo (1:1) for 5 weeks, followed by a washout period of at least 6 weeks, and then the alternate treatment for a further 5 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704047
- Sponsor's protocol ID
- FT1-A201
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No