nonalcoholic fatty liver disease
Conditions
Interventions
BFKB8488A : 50-130mg Q2W
Sponsors
Nanki Toshihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who signed informed consent form - Japanese subjects at 20-75 years old - Diagnosed with NAFLD - Body Mass Index (BMI) of 25-40 - Confirmed a certain amount of liver fat by ultrasonography and MRI
Exclusion criteria
Exclusion criteria: - With a history or current liver diseases, liver dysfunction, or liver disease-related symptoms other than NAFLD - With a history of liver transplantation - With a history or current of eating disorders - Current with Type 1 diabetes, or uncontrolled type 2 diabetes - With a history or current of significant cardiac disease - With a history or current of severe allergic reaction - Current receiving weight loss therapy or diet therapy - With a history of alcohol abuse - A certain amount of blood loss due to blood donation - Women who are pregnant, breastfeeding, possibly pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Confirm the safety and tolerability of repeated subcutaneous administration of BFKB8488A by comparison with placebo - Adverse events - Vital signs - Laboratory examination - 12-lead electrocardiogram phamacokinetics Evaluate the pharmacokinetic profile of repeated subcutaneous doses of BFKB8488A - BFKB8488A serum levels and other pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| other Evaluate immunogenicity after repeated subcutaneous administration of BFKB8488A - Expression frequency of Anti-Drug Antibodies against BFKB8488A | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed