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

Phase 1

Completed

• Conditions: NAFLD
• Interventions: Drug: HM15211; Drug: Placebo of HM15211

• Registration Number: NCT03744182
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Primary Completion: 2020-03-18
• Study Completion: 2020-03-18
• Results First Submitted: 2022-03-18
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Results First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HM15211	HM15211	-
Placebo	Placebo of HM15211	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	baseline and 12 weeks	Change of Body Mass Index from baseline to 12 weeks after IP injection

Trial Locations

Locations (1)

ProSciento Inc.; 🇺🇸 Chula Vista, California, United States