This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Pinnacle Research Group Cullman
Anniston, Alabama, United States
Pinnacle Research Group; Llc, Central
Anniston, Alabama, United States
Southern California Research Center, Inc.
Coronado, California, United States
Stanford Health Care
Stanford, California, United States
Diabetes Research Center
Tustin, California, United States
MD Clinical
Hallandale, Florida, United States
Premier Research Associate, Inc
Miami, Florida, United States
Agile Clinical Research Trials
Atlanta, Georgia, United States
MidWest Clinical Research
Overland Park, Kansas, United States
Hassman Research Institute
Berlin, New Jersey, United States
...and 8 more locations
Percentage of Participants with Adverse Events (AE)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Time frame: Up to 18 weeks following first dose administration
Serum BFKB8488A Concentration
Time frame: On multiple days during treatment period and follow-up (up to 18 weeks following first dose administration)
Change from Baseline in Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)
Participants are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and at least one post-baseline samples if above acceptable limits. The number and percentage of ATA-positive and ATA-negative participants will be summarized by treatment group.
Time frame: On multiple days during treatment period and follow-up (up 18 weeks following first dose administration)
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