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

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HPG1860

Placebo

About this trial

This is an interventional prevention trial for NASH - Nonalcoholic Steatohepatitis focused on measuring NASH

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

South Texas Research Institute (STRI)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

HPG1860 3 mg

HPG1860 5 mg

HPG1860 8 mg

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Safety and tolerability of treatment

Number of participants Treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

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

Percentage of subjects with ≥30% reduction in LFC from baseline

measured by MRI-PDFF at Week 4 and Week 12

Change from baseline (CFB) in liver fat content (LFC) at 4 week

measured by MRI-PDFF at Week 4

Full Information

NCT ID

NCT05338034

First Posted

October 24, 2021

Last Updated

September 15, 2022

Sponsor

Hepagene (Shanghai) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05338034

Brief Title

Phase 2a Study of HPG1860 in Subjects With NASH

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 22, 2021 (Actual)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hepagene (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NASH - Nonalcoholic Steatohepatitis

Keywords

NASH

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

During this study, subjects, investigators, the Sponsor, and the clinical research organization (CRO) (except specific vendors whose role in study conduct requires their unblinding, eg, personnel operationally associated with the interactive response technology [IRT]) will be blinded to the study intervention assignment. Study team personnel will remain blinded throughout the study with the exception of a Sponsor Committee who will review interim analysis results and make decisions regarding dropping and/or adding a treatment cohort and an unblinded study team member assigned to monitor that at least 6 subjects in each dose cohort had serial PK measurements taken.

Allocation

Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HPG1860 3 mg

Arm Type

Experimental

Arm Description

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

Arm Title

HPG1860 5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

HPG1860 8 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HPG1860

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsule

Primary Outcome Measure Information:

Title

Safety and tolerability of treatment

Description

Number of participants Treatment-emergent adverse events (TEAEs)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

liver fat content

Description

Change from baseline (CFB) in liver fat content (LFC) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12

Time Frame

12 week

Title

Percentage of subjects with ≥30% reduction in LFC from baseline

Description

measured by MRI-PDFF at Week 4 and Week 12

Time Frame

4 week and 12 week

Title

Change from baseline (CFB) in liver fat content (LFC) at 4 week

Description

measured by MRI-PDFF at Week 4

Time Frame

4 week

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Males and females between 18 and 75 years of age; inclusive based on the date of Screening

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naim Alkhouri

Organizational Affiliation

Arizona Liver Health - Tucson

Official's Role

Principal Investigator

Facility Information:

Facility Name

South Texas Research Institute (STRI)

City

Texas City

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

still pending

Learn more about this trial

Phase 2a Study of HPG1860 in Subjects With NASH

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