A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
NCT ID: NCT07308548
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-10-11
2026-12-31
Brief Summary
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• 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HP515 40mg group
Two HP515 20 mg Tablets +Two Placebos of HP515 10mg Tablets
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.
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
HP515 50mg group
Two HP515 20mg Tablets + One HP515 10mg Tablet + One Placebo of HP515 10mg Tablet
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
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.
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
HP515 60mg group
Two HP515 20mg Tablets + Two HP515 10mg Tablets
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.
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
Placebo
Two Placebos of HP515 20mg Tablet +Two Placebos of HP515 10mg Tablet
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.
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
Interventions
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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
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.
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
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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Hinova Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Chengdu Seventh People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Liu Man Ting LMT Liu
Role: primary
Liu JingYu LJY chief physician
Role: primary
chief physician
Role: backup
Other Identifiers
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HP515 - 201
Identifier Type: -
Identifier Source: org_study_id