Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 October 2015
• Main ID: NCT02325492
• Date of registration: 12/11/2014
• Prospective Registration: No
• Primary sponsor: Galmed Pharmaceuticals Ltd
• Public title: Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
• Scientific title: Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
• Date of first enrolment: October 2014
• Target sample size: 10
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02325492
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Israel

Contacts

• Name: Asnat Raziel, MD
• Affiliation: Assuta Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female age 18 to 75 years.

2. Presence of newly formed gallstones (size up to 6 mm) with or without sludge
diagnosed by ultrasound within 3 or 6 months after bariatric surgery following normal
ultrasound.

3. Bariatric surgery conducted during the last 12 months

4. Patients with "sleeve gastrectomy" or laparoscopic banding of the upper stomach will
be included.

5. Signature of the written informed consent.

6. Negative pregnancy test at study entry for females of child bearing potential.

7. Females of child bearing potential practicing reliable contraception throughout the
study period (not including oral contraceptives).

8. Hypertensive patients must be well controlled by stable dose of anti-hypertensive
medication for at least 2 months prior to screening (and the stable dose can be
maintained throughout the study).

9. Patients treated with vitamin E(>400IU/die), or Polyunsaturated fatty acid (>2g/d) or
Ursodeoxycholic acid or fish oil can be included if drugs are stopped at least 3
months prior to study enrollment to the study and up to it end.

10. For patients with type 2 Diabetes, glycaemia must be controlled (Glycosylated
Hemoglobin A1C = 8% while any HbA1C increment should not exceed 1% during 6 month
prior to enrollment). If glycaemia is controlled by medications, qualitative change
is not permitted within 3 months prior to randomization and should be avoided during
the study. Treatments with Metformin, Sulfamides and Insulin are authorized.
Sulfamides and insulin are permitted if glycaemia is self-monitored by the patient.

Exclusion Criteria:

1. Patients with ultrasonography evidence of gallstones in gallbladder before having the
bariatric surgery.

2. Patients with no clear ultrasonography evidence of gallstones -free gallbladder
during the year prior their bariatric surgery.

3. Patients with ultrasonography evidence of gallstones more than 1 year following
bariatric surgery.

4. Patients with ultrasonography evidence of gallstones in size greater than 9 mm less
than 1 year following bariatric surgery.

5. Weight >140 Kg or BMI >40

6. Known alcohol and/or any other drug abuse or dependence in the last five years

7. Known history or presence of clinically significant cardiovascular, hepatic,
gastrointestinal, neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder
or nephritic syndrome.

8. History or presence of any disease or condition known to interfere with the
absorption, distribution, metabolism or excretion of drugs including bile salt
metabolism (e.g. inflammatory bowel disease (IDB); previous intestinal (ileal or
colonic) operation; chronic pancreatic; celiac disease or previous vagotomy

9. Uncontrolled blood pressure

10. Patients with HIV

11. Patients with renal dysfunction eGFR< 60.

12. Patients with pancreatitis, cholangitis or cholecystitis in the previous 4 months.

13. Women who are pregnant or breastfeeding

14. Type 1 Diabetes.

15. .Metformin, Fibrates, Statins, Insulin, Sulfonilurea not provided on a stable dose in
the last 6 months.

16. Patients who are treated with Valproic acid, Tamoxifen, Methotreksate, Amiodaron.

17. Treatment with Rifaximin.

18. Homeopathic and/or Alternative treatments. Any treatment should be stopped before the
screening period.

19. Serum creatine phosphokinase (CPK), ALT, AST and/or alkaline phosphatase >3X the
upper limit of normal (ULN). Patients with an intermittent CPK elevation may have the
repeated measurement prior to randomization; a CPK retest > 3X ULN leads to
exclusion.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Gallstones

Intervention(s)

Device: Ultrasound

Drug: Aramchol

Drug: Placebo

Primary Outcome(s)

Complete dissolution of existing gallstones proven by repeated US examined gallbladder [Time Frame: At baseline and week 12]

Secondary Outcome(s)

Prevention of formation of new gallstones during the study period [Time Frame: At baseline and week 12]

Dissolution of sludge. [Time Frame: At baseline and week 12]

Decrease of more than a 50% in number of stones. (change from baseline) [Time Frame: At baseline and week 12]

Secondary ID(s)

Aramchol006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors