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

NCT ID: NCT03744182

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-03-18

Brief 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

Detailed 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.

Conditions

NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HM15211

Group Type: EXPERIMENTAL

HM15211

Intervention Type: DRUG

A sterile solution of HM15211 contained in pre-filled syringes

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo of HM15211

Intervention Type: DRUG

A sterile, matching solution in pre-filled syringes

Interventions

HM15211

A sterile solution of HM15211 contained in pre-filled syringes

Intervention Type: DRUG

Placebo of HM15211

A sterile, matching solution in pre-filled syringes

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ProSciento Inc.

Chula Vista, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HM-TRIA-102

Identifier Type: -

Identifier Source: org_study_id