Phase 1 Completed N=66 Randomized Double-blind Treatment

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

Non-Alcoholic Fatty Liver Disease

Source: ClinicalTrials.gov NCT03744182 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcomePrimary: Number of Participants With Adverse Events — 7; 9; 9; 8 Participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	7; 9; 9; 8; 6; 8	—
PRIMARY Incidence of Clinical Renal Function Lab Abnormalities	-1.111; -0.238; 0.036; -0.754; -0.893; 0.190	—
PRIMARY Vital Signs	7.2; 7.1; -0.7; -3.3; -4.5; 2.2	—
PRIMARY 12-lead ECG	4.2; 1.3; -1.3; 0; -2.2; 2.5	—
SECONDARY Body Mass Index	35.46; 32.91; 37.86; 40.13; 35.74; 34.61	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03744182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.