A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )

A Phase IIa Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HP515 Tablets in Participants With Non - Alcoholic Fatty Liver Disease

A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH ) (NCT07308548) is a Phase 2 interventional studying NAFLD (Non-alcoholic Fatty Liver Disease), sponsored by Hinova Pharmaceuticals Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against NAFLD (Non-alcoholic Fatty Liver Disease) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused NAFLD (Non-alcoholic Fatty Liver Disease) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants must voluntarily sign the willing to sign a consent form form before the trial and fully understand the trial content, process, and possible adverse reactions. 2. Participants must be aged between 18 and 65 years old, including those at the borderline age. 3. At the screening stage, the liver fat fraction must be ≥ 10% 4. 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. 5. 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 Should NOT Join This Trial: 1. The participants have known or suspected allergic reactions 2. Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis 3. Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%); 4. 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 5. Any abnormality in thyroid function tests with clinical significance or a previous history of thyroid disease 6. 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; 7. History of liver transplantation or planning to undergo liver transplantation; 8. Had significant changes in diet or exercise habits in the past 2 months or a weight change of more than 5%; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Participants must voluntarily sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions. 2. Participants must be aged between 18 and 65 years old, including those at the borderline age. 3. At the screening stage, the liver fat fraction must be ≥ 10% 4. 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. 5. 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. Exclusion Criteria: 1. The participants have known or suspected allergic reactions 2. Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis 3. Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%); 4. 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 5. Any abnormality in thyroid function tests with clinical significance or a previous history of thyroid disease 6. 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; 7. History of liver transplantation or planning to undergo liver transplantation; 8. Had significant changes in diet or exercise habits in the past 2 months or a weight change of more than 5%; 9. 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; 10. Pregnant or lactating women; 11. Participants with contraindications to MRI scans; 12. Participants judged by the investigator to be unsuitable for participation in the study.

Treatments Being Tested

DRUG

HP515 10 mg Tablet

Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C. HP515 10mg Tablet, qd

DRUG

Placebo of HP515 10 mg Tablet

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.

DRUG

HP515 20 mg Tablet

Provided by provided by Hinova Pharmaceuticals Inc .Storage: Protect from light, keep sealed, store at ≤25°C; HP515 20 mg Tablet, qd,12 weeks

DRUG

Placebo of HP515 20mg Tablet

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

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Chengdu Seventh People's Hospital

Chengdu, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07308548), the sponsor (Hinova Pharmaceuticals Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07308548 clinical trial studying?

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 dise… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07308548?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07308548?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07308548. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07308548. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.