This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD
This study will be single-blind and conducted in up to 6 cohorts comprising a total of up to 72 obese subjects with NAFLD. Each cohort will enroll subjects to ensure that at least 12 subjects per cohort will complete the study. Subjects will be randomized to investigational product (IP) or placebo in a 3:1 ratio via an Interactive Web Response System (IWRS). Per cohort (n=12 subjects), 9 subjects will be randomized to IP and 3 subjects to placebo. Cohorts may partially overlap after at least 9 subjects have completed 2-4 weeks of treatment (2 weeks of treatment is reached at Visit week 3) and a dose escalation decision has been made. Study drug will be administered weekly over a period of 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
A sterile solution of HM15211 contained in pre-filled syringes
A sterile, matching solution in pre-filled syringes
ProSciento Inc.
Chula Vista, California, United States
Number of Participants With Adverse Events
Cardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation \[cholelithiasis\] were managed following a separate AE guidance document
Time frame: 12 weeks
Incidence of Clinical Renal Function Lab Abnormalities
Observed Values and Change from Baseline in Renal Function of Urea Nitrogen
Time frame: baseline and 12 weeks
Vital Signs
Change from baseline in vital signs (Systolic Blood)
Time frame: baseline and 12 weeks
12-lead ECG
Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF
Time frame: baseline and 12 weeks
Body Mass Index
Change of Body Mass Index from baseline to 12 weeks after IP injection
Time frame: baseline and 12 weeks
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