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HPG1860 for Non-alcoholic Fatty Liver Disease (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
Body mass index (BMI) of ≥25 kg/m2 at Screening.
Nonpregnant, nonlactating women.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 week and 12 week
Awards & highlights

RISE Trial Summary

This trial is testing a new medication for NASH, a Liver disease. It's comparing 3 different doses of the medication to placebo, in order to see if the medication is effective.

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

RISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have provided written informed consent prior to any study-specific procedure.
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You are between the ages of 18 and 75 years.
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You are male and you agree to use a highly effective method of contraception.
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You have hepatic fat assessed by a central reader.
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You are willing and able to comply with study protocol.

RISE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of treatment
Secondary outcome measures
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

RISE 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this clinical investigation?

"This clinical trial is enrolling a cohort of 89 individuals between 18 and 75 years old, who have been diagnosed with fatty liver. In addition to the age requirement, participants must be male or female, employ an effective contraception method for males only; as well as agree to all other restrictions outlined in the study protocol such as BMI ≥ 25 kg/m2 at screening and provide informed consent before any procedures related to this study can occur. Non-pregnant women are also eligible."

Answered by AI

Is enrollment in this study ongoing?

"Clinicaltrials.gov indicates that this trial is not presently enrolling patients, although it was originally posted on November 22nd 2021 and revised at the end of September 2022. Fortunately, there are 234 other medical studies actively looking for research participants currently."

Answered by AI

Is this experiment open to enrollees aged eighty or higher?

"The parameters for enrollment in this trial dictate that each patient is between 18 to 75 years old. Additionally, there are 22 studies specifically catering towards people younger than 18 and 192 clinical trials targeting individuals above the age of 65."

Answered by AI

Could you please elucidate the safety profile of HPG1860?

"Due to the lack of clinical data supporting its efficacy, HPG1860 was scored a 2 in terms of safety. However, there is still some evidence that it can be used safely."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
65+
What site did they apply to?
South Texas Research Institute (STRI)
What portion of applicants met pre-screening criteria?
Met criteria
~27 spots leftby Mar 2025