Proof of Concept Study in Patients With Short Bowel Syndrome

• Status: Active, not recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I/II. proof of concept, open label, two-dose, dose escalation study of NM-002 in adult patients with SBS who previously responded to exenatide. NM-002 is planned to be administered twice, at up to 3 different dose levels, in up to 3 cohorts, each consisting of 3-4 patients. Doses will be administered on Days 1 and 15 by subcutaneous injection. Patients will be monitored for their usage of parenteral supplementation, and will fill out a daily diary for their symptoms of SBS. Urine output will be measured on a daily basis. Patients will be followed for 6 weeks after the second dose.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 9 Meters Biopharma, Inc.; Naia Pharmaceuticals

Criteria

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.