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

Completed · Phase 1 · Has a placebo group

Conditions studied: NAFLD

In brief

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

Key facts

Study ID: NCT03744182
Run by: Hanmi Pharmaceutical Company Limited
People needed: 66
Starts: 2018-11-01
Expected to finish: 2020-03-18
Last updated by the study team: 2025-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify 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 qualify 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

Where it is running

ProSciento Inc. — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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