Phase 2a Study of HPG1860 in Subjects With NASH (RISE)

Hepagene

Status and phase: Active, not recruiting; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: HPG1860

Study type: Interventional

Funder types: Industry

Identifiers

NCT05338034

HPG1860-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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89 participants in 4 patient groups, including a placebo group

HPG1860 3 mg

Experimental group

Description:

20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.

Treatment:

Drug: HPG1860

HPG1860 5 mg

Experimental group

Description:

20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.

Treatment:

Drug: HPG1860

HPG1860 8 mg

Experimental group

Description:

20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.

Treatment:

Drug: HPG1860

Placebo

Placebo Comparator group

Description:

20 subjects will be treated with Placebo once daily at a similar time with or without food.

Treatment:

Drug: Placebo