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

Phase 2
Waitlist Available
Led By Naim Alkhouri
Research Sponsored by Hepagene (Shanghai) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 week and 12 week

Summary

This trial is testing a new drug called HPG1860 on patients with a liver disease known as NASH. The drug aims to reduce liver damage and improve liver function. Different doses of the drug will be compared over a few months.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 week and 12 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 week and 12 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of treatment
Secondary study objectives
Change from baseline (CFB) in liver fat content (LFC) at 4 week
Percentage of subjects with ≥30% reduction in LFC from baseline
liver fat content

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: HPG1860 8 mgExperimental Treatment1 Intervention
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
Group II: HPG1860 5 mgExperimental Treatment1 Intervention
20 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
Group III: HPG1860 3 mgExperimental Treatment1 Intervention
20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
Group IV: PlaceboPlacebo Group1 Intervention
20 subjects will be treated with Placebo once daily at a similar time with or without food.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HPG1860
2019
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Hepagene (Shanghai) Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Naim AlkhouriPrincipal InvestigatorArizona Liver Health - Tucson
~22 spots leftby Dec 2025
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