A Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD and in Subjects With NASH
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 11/18/2018 |
Start Date: | November 1, 2018 |
End Date: | September 28, 2019 |
Contact: | Jahoon Kang, Executive Director |
Email: | jhkang@hanmi.co.kr |
Phone: | +82 2 410 9041 |
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211 in Obese Subjects With NAFLD and in Subjects With NASH
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 and in subjects
with NASH
pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD and in subjects
with NASH
Inclusion Criteria:
- 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%.
Exclusion Criteria:
- 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
We found this trial at
1
site
855 3rd Avenue
Chula Vista, California 91911
Chula Vista, California 91911
Principal Investigator: Linda Morrow, VP, CMO
Click here to add this to my saved trials