A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
Overview
- Phase
- Phase 1
- Intervention
- HM15211
- Conditions
- NAFLD
- Sponsor
- Hanmi Pharmaceutical Company Limited
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Arms & Interventions
HM15211
Intervention: HM15211
Placebo
Intervention: Placebo of HM15211
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: 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
Time Frame: baseline and 12 weeks
Observed Values and Change from Baseline in Renal Function of Urea Nitrogen
Vital Signs
Time Frame: baseline and 12 weeks
Change from baseline in vital signs (Systolic Blood)
12-lead ECG
Time Frame: baseline and 12 weeks
Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF
Secondary Outcomes
- Body Mass Index(baseline and 12 weeks)