A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD

Hanmi Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

NAFLD

Treatments

Drug: Placebo of HM15211

Drug: HM15211

Study type

Interventional

Funder types

Industry

Identifiers

NCT03744182

HM-TRIA-102

Details and patient eligibility

About

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

Full description

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.

Enrollment

66 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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