Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hanmi Pharmaceutical Company Limited
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.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Body mass index ≥ 30 kg/m2
Waist circumference ≤ 57 inches
Fasting Plasma Glucose \< 7 mmol/L (126 mg/dL)
HbA1c \< 6.5%
Controlled Attenuation Parameter ≥ 300 dB/m by FibroScan
Liver fat by MRI-PDFF ≥ 10%.
You may not be if
A history of or active chronic liver disease due to alcohol, auto-immune, HIV, HBV or active HCV-infection or NASH disease
Any history of clinically significant chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease (MELD) ≥ 10
Previous surgical treatment for obesity
Uncontrolled hypertension
Any weight control treatment
History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment
History or current diagnosis of heart disease
Presence of clinically significant ECG findings
History of renal disease or abnormal kidney function tests
History of alcohol or illicit drug abuse
Daily heavy use of cigarettes or any tobacco product
Clareo Health | A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
