HP515 for 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

This trial tests whether daily HP515 tablets can reduce liver fat and are safe in adults (18–65) with non-alcoholic fatty liver disease and liver fat ≥10%.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hinova Pharmaceuticals Inc. (industry)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07308548 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase IIa trial enrolling about 80 adults with NAFLD and liver fat ≥10%. Participants are stratified by body weight and randomized to one of three HP515 dose groups or placebo, receive 12 weeks of treatment, and are followed for safety for 4 additional weeks. The protocol includes serial PK (population and intensive) sampling and PD/biomarker measurements, with efficacy measured by imaging and laboratory markers. The trial tests efficacy, safety, pharmacokinetics, pharmacodynamics, and exploratory target-marker effects.

Who should consider this trial

Good fit: Adults aged 18–65 with non-alcoholic fatty liver disease and liver fat fraction ≥10%, able to use effective contraception and attend study visits, are the intended participants.

Not a fit: People with cirrhosis on biopsy, known allergy to the investigational product, pregnant or unwilling to use contraception, or with liver fat below entry criteria are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, HP515 could lower liver fat and improve liver-related biomarkers, potentially offering a new oral treatment option for people with NAFLD.

How similar studies have performed: Other Phase II programs of oral agents for NAFLD have produced reductions in liver fat by MRI-PDFF in some cases, but no universally approved disease-modifying oral therapy for NAFLD has emerged yet.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Chengdu Seventh People's Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Yang Ming YM Chief physician

Conditions: NAFLD, non-alcoholic, Fatty Liver