Phase 2a Study of HPG1860 in Subjects With NASH

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hepagene (Shanghai) Co., Ltd.

Criteria

Inclusion Criteria:

1. Provision of written informed consent prior to any study-specific procedure.

2. Males and females between 18 and 75 years of age

3. Nonpregnant, nonlactating women.

4. Male subjects must agree to utilize a highly effective method of contraception.

5. Body mass index (BMI) of ≥25 kg/m2 at Screening.

6. Non-cirrhotic NASH subjects.

7. NASH subjects with hepatic fat assessed by a central reader

8. Willing and able to adhere to study restrictions and agree to comply with study protocol.

Exclusion Criteria:

1. Pregnant or lactating females

2. Current significant alcohol consumption

3. Elevated LDL-C with stable dose of statin an or PCSK9 inhibitor

4. Renal dysfunction or nephritic syndrome or a history of nephritis

5. Recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia

6. Uncontrolled hypertension

7. Type 1 diabetes or uncontrolled T2DM

8. Uncontrolled hypothyroidism

9. Liver transplant and/or other significant liver disease or dysfunction

10. HIV antibody positive

11. Known hypersensitivity or formulation excipient

12. Gastrointestinal conditions or procedures that may affect drug absorption

13. Hematologic or coagulation disorders

14. Unstable weight within the last 3 months

15. Active malignancy

16. Unexplained creatine kinase (CK) >3 × ULN

17. Blood donation, blood transfusion

18. Unable to undergo or contraindication to MRI procedure

19. A medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study.