NASH - Nonalcoholic SteatohepatitisPhase 2RISENCT05338034

Phase 2a Study of HPG1860 in Subjects With NASH

A Phase 2 study testing HPG1860 in people with NASH - Nonalcoholic Steatohepatitis, run by Hepagene (Shanghai) Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis
What is being tested?: HPG1860
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 22 Nov 2021to 28 Mar 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

South Texas Research Institute (STRI)
Texas City, Texas, 78240

Other trials in United States

About this study

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

Read the 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.

Conditions: NASH - Nonalcoholic Steatohepatitis
Being tested: HPG1860, Placebo
Keywords: NASH
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HPG1860Drug
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.
PlaceboDrug
Capsule

Study groups in NCT05338034
Study group	Role	What they receive
HPG1860 3 mg	Experimental	20 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food. Receives: 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. Receives: 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. Receives: Drug: HPG1860
Placebo	Placebo comparator	20 subjects will be treated with Placebo once daily at a similar time with or without food. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of Treatment
Number of participants Treatment-emergent adverse events (TEAEs)
Measured: 12 weeks

Secondary outcomes (3)

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
Measured: 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
Measured: 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
Measured: 4 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 202128 Mar 2023

First posted20 Apr 2022
Study start22 Nov 2021
Primary completion28 Feb 2023
Study completion28 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05338034
Sponsor's protocol ID: HPG1860-201
Acronym: RISE
Status last verified: May 2026
First submitted: 24 Oct 2021
Last updated: 28 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: still pending

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)

All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05338034
Acronym / sponsor ID: RISE / HPG1860-201
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: NASH
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Hepagene (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 Nov 2021 (actual)
Primary completion: 28 Feb 2023 (actual)
Study completion: 28 Mar 2023 (actual)
First posted: 20 Apr 2022 (actual)
Results: Posted 28 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
HPG1860 3 mg	Experimental	Drug: HPG186020 subjects will be treated with HPG1860 3 mg once daily at a similar time with or without food.
HPG1860 5 mg	Experimental	Drug: HPG186020 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
HPG1860 8 mg	Experimental	Drug: HPG186020 subjects will be treated with HPG1860 5 mg once daily at a similar time with or without food.
Placebo	Placebo comparator	Drug: Placebo20 subjects will be treated with Placebo once daily at a similar time with or without food.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HPG1860The dosage form for clinical research is a dry-filled capsule for oral administration manufactured as strengths of 3 mg, 5 mg, and 8 mg.	Drug	HPG1860 3 mg, HPG1860 5 mg, HPG1860 8 mg
PlaceboCapsule	Drug	Placebo

Primary outcome

Safety and Tolerability of Treatment
Time frame: 12 weeks
Number of participants Treatment-emergent adverse events (TEAEs)

3 secondary outcomes

Liver Fat Content
Time frame: 12 week
Percentage of Subjects With ≥30% Reduction in LFC From Baseline
Time frame: 4 week and 12 week
Change From Baseline (CFB) in Liver Fat Content (LFC) at 4 Week
Time frame: 4 week

Results and safety

Results posted to the registry on 28 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	22	18
HPG1860 3 mg	22	19
HPG1860 5 mg	21	18
HPG1860 8 mg	22	18

Primary outcome: Safety and Tolerability of Treatment

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 22	HPG1860 3 mg n = 22	HPG1860 5 mg n = 21	HPG1860 8 mg n = 22
Value	12	13	13	18

Population analysed: The Safety Population, used for all the safety summaries, was defined as all randomized subjects who received at least 1 dose of blinded IMP. Subjects were reported according to actual treatment received at the first dose.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 22 (4.5%)	5 of 22 (22.7%)	0 of 22
HPG1860 3 mg	0 of 22 (0%)	9 of 22 (40.9%)	0 of 22
HPG1860 5 mg	0 of 21 (0%)	9 of 21 (42.9%)	0 of 21
HPG1860 8 mg	3 of 22 (13.6%)	12 of 22 (54.5%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. still pending

Related trials for NASH - Nonalcoholic Steatohepatitis

RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Naim Alkhouri principal investigator

Arizona Liver Health - Tucson

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HPG1860 in people with NASH - Nonalcoholic Steatohepatitis, run by Hepagene (Shanghai) Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of Treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05338034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.