Phase 2a Study of HPG1860 in Subjects With NASH
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05338034
- Lead Sponsor
- Hepagene (Shanghai) Co., Ltd.
- Brief Summary
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.
- Detailed Description
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH. Screening will occur up to 5 weeks prior to randomization; all eligible subjects will have baseline hepatic imaging during Screening, prior to randomization. Approximately 80 eligible subjects will be randomized 1:1:1:1 on Day 1/Week 0 (T1) to receive either HPG1860 3 mg (n = 20), or 5 mg (n = 20), or 8 mg (n = 20), or placebo (n = 20) for 12 weeks. Following a preplanned interim analysis, a dose cohort may be dropped and/or added.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 89
- Provision of written informed consent prior to any study-specific procedure.
- Males and females between 18 and 75 years of age
- Nonpregnant, nonlactating women.
- Male subjects must agree to utilize a highly effective method of contraception.
- Body mass index (BMI) of ≥25 kg/m2 at Screening.
- Non-cirrhotic NASH subjects.
- NASH subjects with hepatic fat assessed by a central reader
- Willing and able to adhere to study restrictions and agree to comply with study protocol.
- Pregnant or lactating females
- Current significant alcohol consumption
- Elevated LDL-C with stable dose of statin an or PCSK9 inhibitor
- Renal dysfunction or nephritic syndrome or a history of nephritis
- Recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes or uncontrolled T2DM
- Uncontrolled hypothyroidism
- Liver transplant and/or other significant liver disease or dysfunction
- HIV antibody positive
- Known hypersensitivity or formulation excipient
- Gastrointestinal conditions or procedures that may affect drug absorption
- Hematologic or coagulation disorders
- Unstable weight within the last 3 months
- Active malignancy
- Unexplained creatine kinase (CK) >3 × ULN
- Blood donation, blood transfusion
- Unable to undergo or contraindication to MRI procedure
- A medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HPG1860 3 mg HPG1860 20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food. HPG1860 5 mg HPG1860 20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food. Placebo Placebo 20 subjects will be treated with Placebo once daily at a similar time with or without food. HPG1860 8 mg HPG1860 20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
- Primary Outcome Measures
Name Time Method Safety and tolerability of treatment 12 weeks Number of participants Treatment-emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method Change from baseline (CFB) in liver fat content (LFC) at 4 week 4 week measured by MRI-PDFF at Week 4
liver fat content 12 week Change from baseline (CFB) in liver fat content (LFC) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12
Percentage of subjects with ≥30% reduction in LFC from baseline 4 week and 12 week measured by MRI-PDFF at Week 4 and Week 12
Trial Locations
- Locations (1)
South Texas Research Institute (STRI)
🇺🇸Texas City, Texas, United States