NAFLD (Non-alcoholic Fatty Liver Disease)Phase 2NASH/MASHNCT07308548
A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
A Phase 2 study testing HP515 10 mg Tablet and HP515 20 mg Tablet in people with NAFLD (Non-alcoholic Fatty Liver Disease), run by Hinova Pharmaceuticals Inc. at 2 sites in China.
Trial summary
Primary Objective: To evaluate the efficacy of HP515 tablets in participants with non-alcoholic fatty liver disease. Secondary objectives: To evaluate the safety of HP515 tablets in participants with non-alcoholic fatty liver disease; To evaluate the pharmacokinetic of HP515 tablets in participants with non-alcoholic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD (Non-alcoholic Fatty Liver Disease)
- What is being tested?
- HP515 10 mg Tablet and HP515 20 mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 11 Oct 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must voluntarily sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions.
- Participants must be aged between 18 and 65 years old, including those at the borderline age.
- At the screening stage, the liver fat fraction must be ≥ 10%
- Female participants must not donate eggs from the start of the screening until the end of the study and within 28 days after discontinuing the study drug; male participants must not donate sperm from the start of the screening until the end of the study and within 28 days after discontinuing the study drug.
- Participants must agree to use contraception during the study period and for the next 6 months after the last administration of the study drug, and must agree to continuously use effective contraceptive measures.
Who cannot join
- The participants have known or suspected allergic reactions
- Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis
- Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%);
- Suspected other liver and gallbladder diseases through medical history and laboratory tests, which, based on the investigator's judgment, may affect safety or efficacy evaluation
- Any abnormality in thyroid function tests with clinical significance or a previous history of thyroid disease
- Within the previous 1 year, had myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack, or other cardiovascular and cerebrovascular events that led to hospitalization;
Show all 12Show fewer
- History of liver transplantation or planning to undergo liver transplantation;
- Had significant changes in diet or exercise habits in the past 2 months or a weight change of more than 5%;
- Participants who used drugs that changed the activity of CYP2C8 of liver enzymes within 4 weeks or 5 half-lives (whichever is longer), including strong inhibitors and inducers of liver metabolic enzymes;
- Pregnant or lactating women;
- Participants with contraindications to MRI scans;
- Participants judged by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Liu Man Ting LMT Liu, +86-01056118567, IRB@btch.edu.cn
- Recruiting
Chengdu Seventh People's Hospital
Chengdu, Sichuan, 610041
Liu JingYu LJY chief physician, +86-13540087274, liujy92@163.com
chief physician
About this study
Official title: A Phase IIa Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HP515 Tablets in Participants With Non - Alcoholic Fatty Liver Disease
Primary Objective:
- To evaluate the efficacy of HP515 tablets in participants with non-alcoholic fatty liver disease.
Read more
Secondary objectives:
- To evaluate the safety of HP515 tablets in participants with non-alcoholic fatty liver disease;
- To evaluate the pharmacokinetic of HP515 tablets in participants with non-alcoholic fatty liver disease;
- To evaluate the pharmacodynamic effects of HP515 tablets in participants with non-alcoholic fatty liver disease;
Exploratory objective:
- To evaluate the impact of HP515 tablets on target markers in participants with non-alcoholic fatty liver disease.
The study includes a screening period of 4 weeks, a treatment period of 12 weeks, and a safety follow-up period of 4 weeks.
Read the detailed description
This study is a multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial conducted in participants with non-alcoholic fatty liver disease.
The trial includes a screening period (D-28 to D-1), a treatment period (Week 1 to Week 12), and a safety follow-up period (Week 13 to Week 16).
Eligible participants are randomized based on stratification factors \[D1 body weight <80 kg vs ≥80 kg]. Participants with body weight <80 kg are randomized in a 2:2:1 ratio to HP515 40 mg group, HP515 50 mg group, and placebo group. Participants with body weight ≥80 kg are randomized in a 2:1 ratio to HP515 60 mg group and placebo group. Each HP515 group enrolls 20 participants, totaling 60 participants, and the placebo group enrolls 20 participants, with a total of 80 participants enrolled.
All participants receive 12 weeks of medication, and the entire study process includes evaluation of efficacy and safety for all participants, as well as evaluation of targeted biomarkers.
All participants provided Pop-PK blood samples on an empty stomach before morning dosing at the end of Weeks 2, 6, 8, 10, and 12. Intensive blood sampling was performed for all participants completing 4 weeks of treatment or withdrawing early before the end of Week 4. Participants who completed the early withdrawal visit after at least 1 week of continuous dosing and did not discontinue medication prior to the in-person visit were encouraged to complete intensive PK sampling. ≥MRI-PDFF and FibroScan examinations were performed during the screening period, at 12 weeks of treatment, and at early withdrawal visits (requiring a minimum of 6 weeks of medication duration). Participants who completed 12 weeks of treatment completed the treatment phase, while those who completed the 16-week safety follow-up completed the trial.
- Being tested
- HP515 10 mg Tablet, Placebo of HP515 10 mg Tablet, HP515 20 mg Tablet, Placebo of HP515 20mg Tablet
- Keywords
- non-alcoholic, Fatty Liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP515 10 mg TabletDrug
Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C. HP515 10mg Tablet, qd
Placebo of HP515 10 mg TabletDrug
Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C. Placebo of HP515 10 mg Tablet ,qd , 12 weeks.
HP515 20 mg TabletDrug
Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C; HP515 20 mg Tablet, qd,12 weeks
Placebo of HP515 20mg TabletDrug
Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C; Placebo of HP515 20 mg Tablet, qd,12 weeks
| Study group | Role | What they receive |
|---|---|---|
| HP515 40mg group | Experimental | Two HP515 20 mg Tablets +Two Placebos of HP515 10mg Tablets Receives: Drug: Placebo of HP515 10 mg Tablet; Drug: HP515 20 mg Tablet |
| HP515 50mg group | Experimental | Two HP515 20mg Tablets + One HP515 10mg Tablet + One Placebo of HP515 10mg Tablet Receives: Drug: HP515 10 mg Tablet; Drug: Placebo of HP515 10 mg Tablet; Drug: HP515 20 mg Tablet |
| HP515 60mg group | Experimental | Two HP515 20mg Tablets + Two HP515 10mg Tablets Receives: Drug: Placebo of HP515 10 mg Tablet; Drug: HP515 20 mg Tablet |
| Placebo | Placebo comparator | Two Placebos of HP515 20mg Tablet +Two Placebos of HP515 10mg Tablet Receives: Drug: Placebo of HP515 10 mg Tablet; Drug: Placebo of HP515 20mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative change in liver fat fraction from the baseline by magnetic resonance proton density fat fraction (MRI-PDFF).
Relative change from baseline is calculated for each subject as 100% x [(Week 12 Value - Baseline Value)/Baseline Value].
Measured: Baseline and Week 12.
Secondary outcomes (7)
The absolute change in liver fat fraction from the baseline by magnetic resonance proton density fat fraction (MRI-PDFF).
Absolute change from baseline is calculated for each subject as [(Week 12 Value - Baseline Value)].
Measured: Baseline and Week 12.
At the 12-week treatment period, through MRI-PDFF measurement, the proportion of participants whose liver fat fraction decreased by more than 30% or 50%.
Proportion of subjects with ≥30% or 50% relative reduction in liver fat content by MRI-PDFF at Week 12
Measured: Week 12.
The percentage changes of blood lipid
Percent change from baseline of low-density lipoprotein cholesterol (LDL-C)
Measured: Baseline, up to 12 weeks.
Number and Percentage of participants with any Treatment Emergent adverse events as assessed by CTCAE v5.0.[Time Frame: up to 16 weeks.]
Safety of HP515 based on Adverse Events and Changes in Laboratory Values、vital signs, physical examination, 12-lead electrocardiogram.
Measured: Up to 16 weeks.
Assessment of pharmacokinetic parameters of HP515 : Maximum concentration (Cmax)
Measured: Baseline, up to 12 weeks
Assessment of pharmacokinetic parameters of HP515 : area under the concentration-time curve (AUC)
Measured: Base line and up to 12 weeks
Assessment of pharmacokinetic parameters of HP515: Time to maximum concentration (Tmax)
Measured: Base line and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start11 Oct 2025
- Primary completion13 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD (Non-alcoholic Fatty Liver Disease)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hinova Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308548
- Sponsor's protocol ID
- HP515 - 201
- Acronym
- NASH/MASH
- Status last verified
- Dec 2025
- First submitted
- 14 Sep 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the unpublished information provided by the sponsor to the researchers and any data generated from this trial are confidential and are exclusive to the sponsor. The researchers agree to keep this information confidential and use it only to complete this study. Such information may not be used for any other purpose without the written consent of the sponsor. The trial results will be presented in the form of a clinical trial report (CSR), which includes the data from all participating units. Any data derived from the trial and involving copyright protection belong to the sponsor. The sponsor has the right to publish these materials and information.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HP515 Tablets in Participants With Non - Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07308548
- Acronym / sponsor ID
- NASH/MASH / HP515 - 201
- Keywords
- non-alcoholic, Fatty Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hinova Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- 13 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To evaluate the efficacy of HP515 tablets in participants with non-alcoholic fatty liver disease.
Secondary objectives:
- To evaluate the safety of HP515 tablets in participants with non-alcoholic fatty liver disease;
- To evaluate the pharmacokinetic of HP515 tablets in participants with non-alcoholic fatty liver disease;
- To evaluate the pharmacodynamic effects of HP515 tablets in participants with non-alcoholic fatty liver disease;
Exploratory objective:
- To evaluate the impact of HP515 tablets on target markers in participants with non-alcoholic fatty liver disease.
The study includes a screening period of 4 weeks, a treatment period of 12 weeks, and a safety follow-up period of 4 weeks.
Detailed description
This study is a multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial conducted in participants with non-alcoholic fatty liver disease.
The trial includes a screening period (D-28 to D-1), a treatment period (Week 1 to Week 12), and a safety follow-up period (Week 13 to Week 16).
Eligible participants are randomized based on stratification factors \[D1 body weight <80 kg vs ≥80 kg]. Participants with body weight <80 kg are randomized in a 2:2:1 ratio to HP515 40 mg group, HP515 50 mg group, and placebo group. Participants with body weight ≥80 kg are randomized in a 2:1 ratio to HP515 60 mg group and placebo group. Each HP515 group enrolls 20 participants, totaling 60 participants, and the placebo group enrolls 20 participants, with a total of 80 participants enrolled.
All participants receive 12 weeks of medication, and the entire study process includes evaluation of efficacy and safety for all participants, as well as evaluation of targeted biomarkers.
All participants provided Pop-PK blood samples on an empty stomach before morning dosing at the end of Weeks 2, 6, 8, 10, and 12. Intensive blood sampling was performed for all participants completing 4 weeks of treatment or withdrawing early before the end of Week 4. Participants who completed the early withdrawal visit after at least 1 week of continuous dosing and did not discontinue medication prior to the in-person visit were encouraged to complete intensive PK sampling. ≥MRI-PDFF and FibroScan examinations were performed during the screening period, at 12 weeks of treatment, and at early withdrawal visits (requiring a minimum of 6 weeks of medication duration). Participants who completed 12 weeks of treatment completed the treatment phase, while those who completed the 16-week safety follow-up completed the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HP515 40mg group | Experimental | Drug: Placebo of HP515 10 mg Tablet, Drug: HP515 20 mg TabletTwo HP515 20 mg Tablets +Two Placebos of HP515 10mg Tablets |
| HP515 50mg group | Experimental | Drug: HP515 10 mg Tablet, Drug: Placebo of HP515 10 mg Tablet, Drug: HP515 20 mg TabletTwo HP515 20mg Tablets + One HP515 10mg Tablet + One Placebo of HP515 10mg Tablet |
| HP515 60mg group | Experimental | Drug: Placebo of HP515 10 mg Tablet, Drug: HP515 20 mg TabletTwo HP515 20mg Tablets + Two HP515 10mg Tablets |
| Placebo | Placebo comparator | Drug: Placebo of HP515 10 mg Tablet, Drug: Placebo of HP515 20mg TabletTwo Placebos of HP515 20mg Tablet +Two Placebos of HP515 10mg Tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must voluntarily sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions.
- Participants must be aged between 18 and 65 years old, including those at the borderline age.
- At the screening stage, the liver fat fraction must be ≥ 10%
- Female participants must not donate eggs from the start of the screening until the end of the study and within 28 days after discontinuing the study drug; male participants must not donate sperm from the start of the screening until the end of the study and within 28 days after discontinuing the study drug.
- Participants must agree to use contraception during the study period and for the next 6 months after the last administration of the study drug, and must agree to continuously use effective contraceptive measures.
Key exclusion criteria (12 listed)
- The participants have known or suspected allergic reactions
- Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis
- Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%);
- Suspected other liver and gallbladder diseases through medical history and laboratory tests, which, based on the investigator's judgment, may affect safety or efficacy evaluation
- Any abnormality in thyroid function tests with clinical significance or a previous history of thyroid disease
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 |
|---|---|---|
| HP515 10 mg TabletProvided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C. HP515 10mg Tablet, qd | Drug | HP515 50mg group |
| Placebo of HP515 10 mg TabletProvided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C. Placebo of HP515 10 mg Tablet ,qd , 12 weeks. | Drug | HP515 40mg group, HP515 50mg group, HP515 60mg group, Placebo |
| HP515 20 mg TabletProvided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C; HP515 20 mg Tablet, qd,12 weeks | Drug | HP515 40mg group, HP515 50mg group, HP515 60mg group |
| Placebo of HP515 20mg TabletProvided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C; Placebo of HP515 20 mg Tablet, qd,12 weeks | Drug | Placebo |
Primary outcome
The relative change in liver fat fraction from the baseline by magnetic resonance proton density fat fraction (MRI-PDFF).
Time frame: Baseline and Week 12.
Relative change from baseline is calculated for each subject as 100% x [(Week 12 Value - Baseline Value)/Baseline Value].
7 secondary outcomes
The absolute change in liver fat fraction from the baseline by magnetic resonance proton density fat fraction (MRI-PDFF).
Time frame: Baseline and Week 12.
At the 12-week treatment period, through MRI-PDFF measurement, the proportion of participants whose liver fat fraction decreased by more than 30% or 50%.
Time frame: Week 12.
The percentage changes of blood lipid
Time frame: Baseline, up to 12 weeks.
Number and Percentage of participants with any Treatment Emergent adverse events as assessed by CTCAE v5.0.[Time Frame: up to 16 weeks.]
Time frame: Up to 16 weeks.
Assessment of pharmacokinetic parameters of HP515 : Maximum concentration (Cmax)
Time frame: Baseline, up to 12 weeks
Assessment of pharmacokinetic parameters of HP515 : area under the concentration-time curve (AUC)
Time frame: Base line and up to 12 weeks
Assessment of pharmacokinetic parameters of HP515: Time to maximum concentration (Tmax)
Time frame: Base line and up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. All the unpublished information provided by the sponsor to the researchers and any data generated from this trial are confidential and are exclusive to the sponsor. The researchers agree to keep this information confidential and use it only to complete this study. Such information may not be used for any other purpose without the written consent of the sponsor. The trial results will be presented in the form of a clinical trial report (CSR), which includes the data from all participating units. Any data derived from the trial and involving copyright protection belong to the sponsor. The sponsor has the right to publish these materials and information.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HP515 10 mg Tablet and HP515 20 mg Tablet in people with NAFLD (Non-alcoholic Fatty Liver Disease), run by Hinova Pharmaceuticals Inc. at 2 sites in China.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Ming YM Chief physician (+86-15810092973, ymicecream@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative change in liver fat fraction from the baseline by magnetic resonance proton density fat fraction (MRI-PDFF). (time frame: Baseline and Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.