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

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

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

Study Overview

• Status: Completed
• Conditions: NAFLD
• Intervention / Treatment: Drug: HM15211; Drug: Placebo of HM15211

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • ProSciento Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo of HM15211; A sterile, matching solution in pre-filled syringes
Experimental: HM15211	Drug: HM15211; A sterile solution of HM15211 contained in pre-filled syringes

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): March 18, 2020

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HM-TRIA-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No