A Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD

• Status: Completed
• Trial end date: 2020-03-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

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