The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease)… (NCT06044467) | Clinical Trial Compass
CompletedPhase 1
The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects
Israel16 participantsStarted 2018-12-11
Plain-language summary
A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) \< 3 that are in general good health and have normal liver functions to be treated with CM-101.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with US confirmation of NAFLD without evidence of NASH;
✓. Patients with normal liver function tests (i.e. ALT, AST and ALP).
✓. Patients in general good health expected for the preceding 6 months;
✓. Women of childbearing potential must agree to use an approved form of contraception prior to study entry and for the duration of study participation through 60 days after the last dose of the study medication. Confirmation that female patients are not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women;
✓. Male patients must agree to use a barrier method of contraception or abstinence for the duration of study participation through 60 days after the last dose of the study medication;
✓. Patient must be able to read, understand, and sign the informed consent forms (ICF), communicate with the investigator, and understand and comply with protocol requirements
Exclusion criteria
✕. Patients with medical/surgical history of gastric bypass surgery, orthotopic liver transplant (OLT) or patients that are planned for such interventions;
✕. Documented history of chronic liver disease (e.g., autoimmune hepatitis (\>1:160 ANA with histologic features), Wilson's disease, Hemochromatosis (Ferritin \>500 ug/L and percent iron saturation \>45%), Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Alcoholic Liver Disease);
✕
What they're measuring
1
Incidence and characteristics of adverse events (AEs) occurring following multiple doses
Timeframe: Up to 18 weeks
2
Evaluation of the development of anti-drug antibodies (ADA) - Study Part 1
✕. Known human immunodeficiency virus (HIV) infection (HIV Ab and HIV ribonucleic acid (HIV RNA) positive);
✕. Patients with diabetes mellitus type 1;
✕. Patients with uncontrolled diabetes mellitus type 2, i.e. HbA1c ≥ 9% (75 mmol/mol) at the time of screening or patients that are treated with insulin;
✕. Patients treated with chronic medication including but not limited to anti-retrovirals, tamoxifen, methotrexate, cyclophosphamide, isotretinoin, bile acid binding resins, or pharmacologic doses of oral glucocorticoids (≥10 mg of prednisone per day or equivalent) within the 12 weeks of screening;