Phase 2a Study of HPG1860 in Subjects With NASH

NCT05338034 | Unknown Phase 2 FDA Drug

• 1 other identifier: HPG1860-201
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

NASH

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of treatment

  Number of participants Treatment-emergent adverse events (TEAEs)

  12 weeks

Secondary Outcomes (3)

• liver fat content

  12 week

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

  4 week and 12 week

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

  4 week

Study Arms (4)

HPG1860 3 mg

EXPERIMENTAL

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

Drug: HPG1860

HPG1860 5 mg

EXPERIMENTAL

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

Drug: HPG1860

HPG1860 8 mg

EXPERIMENTAL

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

Drug: HPG1860

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

HPG1860 DRUG

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.

HPG1860 3 mg; HPG1860 5 mg; HPG1860 8 mg

Placebo DRUG

Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Males and females between 18 and 75 years of age; inclusive based on the date of Screening
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hepagene (Shanghai) Co., Ltd.: lead

Study Sites (1)

South Texas Research Institute (STRI)

Texas City, Texas, 78240, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Naim Alkhouri

  Arizona Liver Health - Tucson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: April 20, 2022
• Study Start: November 22, 2021
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)