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

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

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.

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: Placebo; Drug: HPG1860

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Texas City, Texas, United States, 78240
      • South Texas Research Institute (STRI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPG1860 3 mg; 20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.	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.
Experimental: HPG1860 5 mg; 20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.	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.
Experimental: HPG1860 8 mg; 20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.	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 Comparator: Placebo; 20 subjects will be treated with Placebo once daily at a similar time with or without food.	Drug: Placebo; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of Treatment	Number of participants Treatment-emergent adverse events (TEAEs)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of Subjects With ≥30% Reduction in LFC From Baseline	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
Change From Baseline (CFB) in Liver Fat Content (LFC) at 4 Week	Change from baseline (CFB) in liver fat content (LFC) measured by MRI-PDFF at Week 4	4 week

Collaborators and Investigators

• Sponsor: Hepagene (Shanghai) Co., Ltd.
• Investigators: Principal Investigator: Naim Alkhouri, Arizona Liver Health - Tucson

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: October 24, 2021
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NASH
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HPG1860-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: still pending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No