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

Use our guide to learn which trials are right for you!

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


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
Principal Investigator: Linda Morrow, VP, CMO
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials