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

NCT07308548 | Recruiting Phase 2

• 1 other identifier: HP515 - 201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

NAFLD (Non-alcoholic Fatty Liver Disease)

Keywords

non-alcoholic; Fatty Liver

Outcome Measures

Primary Outcomes (1)

• 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 \[(Week 12 Value - Baseline Value)/Baseline Value\].

  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).

  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%.

  Week 12.

• The percentage changes of blood lipid

  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.]

  Up to 16 weeks.

• Assessment of pharmacokinetic parameters of HP515 : Maximum concentration (Cmax)

  Baseline, up to 12 weeks

Study Arms (4)

HP515 40mg group

EXPERIMENTAL

Two HP515 20 mg Tablets +Two Placebos of HP515 10mg Tablets

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

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

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

Drug: Placebo of HP515 10 mg Tablet; Drug: Placebo of HP515 20mg Tablet

Interventions

HP515 10 mg Tablet DRUG

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

HP515 50mg group

Placebo of HP515 10 mg Tablet DRUG

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 40mg group; HP515 50mg group; HP515 60mg group; Placebo

HP515 20 mg Tablet DRUG

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 40mg group; HP515 50mg group; HP515 60mg group

Placebo of HP515 20mg Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Hinova Pharmaceuticals Inc.: lead

Study Sites (2)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

NOT YET RECRUITING

Chengdu Seventh People's Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

Tablets

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Yang Ming YM Chief physician

CONTACT

+86-15810092973; ymicecream@163.com

Wei WL chief physician

CONTACT

+86-15810092973; weelai@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: December 29, 2025
• Study Start: October 11, 2025
• Primary Completion (Estimated): August 13, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)