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

NAFLD Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211 in Obese Subjects With NAFLD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744182
• Other study ID #: HM-TRIA-102
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: March 18, 2020

Study information

• Verified date: September 2021
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• HM15211
A sterile solution of HM15211 contained in pre-filled syringes
• Placebo of HM15211
A sterile, matching solution in pre-filled syringes

Locations

Country	Name	City	State
United States	ProSciento Inc.	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence of adverse events	12 weeks
Primary	Clinical lab abnormalities	Incidence of clinical lab abnormalities	12 weeks
Primary	Physical examination	Incidence and severity of clinical findings on physical examination	12 weeks
Primary	Vital signs	Change from baseline in vital signs	12 weeks
Primary	12-lead ECG	Change from baseline in 12-lead ECG	12 weeks