New pill aims to shrink fatty liver in 12 weeks
NCT ID NCT07308548
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental pill called HP515 for people with non-alcoholic fatty liver disease (NAFLD). About 80 adults aged 18 to 65 with at least 10% liver fat will take the drug for 12 weeks. The main goal is to see if it reduces liver fat measured by MRI, while also checking safety and how the body processes the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tsinghua Changgung Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 102218, China
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Chengdu Seventh People's Hospital
RECRUITINGChengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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