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

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211(Efocipegtrutide) 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

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.

• 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: Yes

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: Sequential 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
Number of Participants With Adverse Events	Cardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation [cholelithiasis] were managed following a separate AE guidance document	12 weeks
Incidence of Clinical Renal Function Lab Abnormalities	Observed Values and Change from Baseline in Renal Function of Urea Nitrogen	baseline and 12 weeks
Vital Signs	Change from baseline in vital signs (Systolic Blood)	baseline and 12 weeks
12-lead ECG	Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF	baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Change of Body Mass Index from baseline to 12 weeks after IP injection	baseline and 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

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