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Proof of Concept Study in Patients With Short Bowel Syndrome
A Phase I/II Proof of Concept, Open-Label, Repeat Dose, Dose Escalation Study of NM-002 in Adult Patients With Short Bowel Syndrome (SBS)
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
12
estimated
Study population
Gastrointestinal (gastroparesis / short bowel / pancreatitis)
Key I/E criterion
—
Primary endpoint
•Treatment-emergent AEs (any)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Males and females with SBS secondary to surgical resection of small intestine, with or without an intact colon
2. 18-75 years of age at the time of screening
3. Female subjects must be postmenopausal (at least 2 years prior to dosing) or surgically sterile or agree to use an acceptable form of birth control from screening until 30 days after last dose. If oral contraceptives are used, Subject must have been on a stable dose for ≥6 months. (See below, "Participation of Women", for additional detail.)
4. Male subjects must agree to use an acceptable form of birth control during the study and for 90 days after the last dose. Male subjects may not donate sperm for 90 days after last dose.
5. At least 6 months since last surgical bowel resection
6. Patients may be on Parenteral support (nutrition and/or fluid and electrolytes [PS]) for at least some of their nutritional needs.
7. If on PS, stable administration of PS volume for 1 month (±20% vol) prior to enrollment.
8. Able to ingest solid foods and drink
9. Willing to adhere to a defined oral intake of fluids on certain days as required by protocol and based on the individual's routine daily consumption.
Exclusion criteria
1. Positive results on the HIV, Hepatitis, or drug screens.
2. Pregnancy or lactation
3. Body mass index <18 or >30 kg/m2
4. Clinically significant intestinal adhesions and/or chronic abdominal pain
5. Active Crohn's disease or IBD (as evaluated by standard procedures employed by the investigator/institution). If in remission, must be ≥12 weeks of remission prior to enrollment.
6. If on chronic systemic narcotics, the patient must have been on a stable dose for >12 weeks
7. Inflammatory bowel disease patients who have NOT been on a stable drug treatment regimen for at least the past 3 months.
8. Visible blood in the stool within the last 3 months
9. Catheter sepsis experienced within the last 3 months
10. Known heart failure or active coronary disease
11. Known celiac disease
12. Radiation enteritis, scleroderma, coeliac disease, refractory or tropical sprue, diabetes
13. Alcohol or drug abuse within the last 12 months
14. Inadequate hepatic function as defined by: ALT and ASAST both >2.0X ULN; TBL >2X ULN; or ALP >2.5X ULN
15. Inadequate renal function as defined by serum creatinine <0.7 or >1.3 mg/dL (in men) and <0.6 or >1.1 mg/dL in women.
16. Personal or family history of medullary thyroid cancer.
17. History of pancreatitis.
18. Any patient who receives insulin in their PS.
19. Any hospitalization within 1 month before screening visit
20. Systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab, or mycophenolate mofetil (CellCept®) within 30 days of screening
21. Any use of growth hormone, or growth factors such as native GLP-2 or GLP-2 analog (teduglutide) within the last 3 months
22. Use of antibiotics within the last 30 days
23. Subject not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements.
Endpoints (1)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
1 endpointTo assess the safety and tolerability of repeated doses of NM002 three different dose levels
Time frame:56 days
Treatment-emergent AEs (any)
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.