Status:
UNKNOWN
Phase 2a Study of HPG1860 in Subjects With NASH
Lead Sponsor:
Hepagene (Shanghai) Co., Ltd.
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ph...
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 ph...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05338034
Start Date
November 22 2021
End Date
March 1 2023
Last Update
September 16 2022
Active Locations (1)
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1
South Texas Research Institute (STRI)
Texas City, Texas, United States, 78240