Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
Status:
Withdrawn
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be
randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of
0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Subjects will record
adverse events and daily administration of study medication in a subject diary. This will
serve as a measure of compliance and record of safety and tolerability. Subjects will be
followed up for 30 days following completion of treatment.
Study visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters
(body mass index [BMI] and waist circumference), serum lipid profiles, immunological markers
(c-reactive protein [CRP] and an array of cytokines), hepatic enzymes and functions
(13C-methacetin breath test [MBT]) and liver steatosis/fibrosis, which will be compared to
baseline levels (Day 1).
The safety and tolerability of the treatment regimen will be determined by monitoring vital
signs, laboratory values, adverse events and physical findings throughout the study. In
addition, its efficacy will be established upon either reduced Day 30 serum alanine
aminotransferase (ALT) levels, reduced hemoglobin A1c (HbA1c) or improved homeostasis model
assessment (HOMA) or HOMA of insulin resistance (HOMA-IR) scores as compared to baseline (Day
1). In addition, to assess the efficacy of the tested Foralumab Solution regimen in improving
overall subject status, a battery of exploratory metabolic, immunologic and hepatic markers
will be evaluated on Days 30 and 60.