Clareo Health | A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease
A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For T2DM Cohort only:
Body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2.
A confirmed diagnosis of Type 2 diabetes ≥ 6 months at screening
Current stable treatment (at least 3 months) for diabetes
Hemoglobin A1c (HbA1c) ≥ 6.8% and ≤ 9.0%.
For women of childbearing potential, agreement to remain abstinent or use reliable contraception during treatment period and for at least 42 days after last dose of study drug
For men, agreement to remain abstinent or use reliable contraception and agree to refrain from donating sperm
For NAFLD cohort only:
BMI ≥ 25 kg/m2 and ≤ 40 kg/m2
At screening, confirmed liver fat by ultrasound OR calculated Liver Fat ≥ 10% using variables from the NAFLD liver fat score
Hepatic steatosis on magnetic resonance imaging (MRI; ≥ 10% average liver proton density fat fraction \[PDFF\]) prior to randomization.
You may not be if
Pregnant, lactating, or intending to become pregnant within 42 days after the last dose of study drug is administered
Suspected or confirmed diagnosis of Type 1 diabetes
Significant cardiac disease
Any psychiatric illness that increases the risk of participation in the study
History of severe allergic, anaphylactic, or other hypersensitivity reactions, or severe systemic bacterial, fungal, or parasitic infections
Poor peripheral venous access
Received blood products within 2 months before dosing
Donation or loss of blood within 30-56 days prior to study drug administration
Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
Liver enzymes greater than acceptable limits
History of eating disorders or surgical procedures for weight loss
Active participation in a structured weight loss or dietary program
Treatment with investigational therapy or exposure to any biological therapy
Illicit drug use, marijuana use, or alcohol abuse
Current use of more than one pack of cigarettes a day or equivalent nicotine- containing products
Any serious medical condition or abnormality in clinical laboratory tests
