Phase 2a Study of HPG1860 in Subjects With NASH

NASH - Nonalcoholic Steatohepatitis Clinical Trial

— RISE  

Official title:

A Randomized, Double-blind, Placebo-controlled Parallel Group Phase 2a Study to Evaluate the Efficacy and Safety of HPG1860 in Subjects With Nonalcoholic Steatohepatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05338034
• Other study ID #: HPG1860-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 22, 2021
• Est. completion date: March 2023

Study information

• Verified date: September 2022
• Source: Hepagene (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 89
• Est. completion date: March 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• HPG1860
The dosage form for clinical research is a dry-filled capsule for oral administration manufactured as strengths of 3 mg, 5 mg, and 8 mg.
• Placebo
Capsule

Locations

Country	Name	City	State
United States	South Texas Research Institute (STRI)	Texas City	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hepagene (Shanghai) Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of treatment	Number of participants Treatment-emergent adverse events (TEAEs)	12 weeks
Secondary	liver fat content	Change from baseline (CFB) in liver fat content (LFC) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12	12 week
Secondary	Percentage of subjects with =30% reduction in LFC from baseline	measured by MRI-PDFF at Week 4 and Week 12	4 week and 12 week
Secondary	Change from baseline (CFB) in liver fat content (LFC) at 4 week	measured by MRI-PDFF at Week 4	4 week