HP515 for non-alcoholic fatty liver disease (NASH/MASH)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chengdu Seventh People's Hospital
  Chengdu, Sichuan, China Recruiting
• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Yang Ming YM Chief physician
• Email: ymicecream@163.com
• Phone: +86-15810092973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low‑methoxy pectin for inflammation, gut microbiome, and metabolic health in MASLD

  This tests whether taking daily low‑methoxy pectin for six weeks can reduce inflammation and improve gut bacteria and metabolic markers in adults with MASLD.

  Recruiting at 3 sites University of Nottingham · Nottingham, United Kingdom and 2 other locations · NCT07093346

• Ultrasound method to measure liver fat percentage

  This study will test whether a new ultrasound technique can accurately measure the percentage of fat in the liver for adults with or at risk for MASLD (formerly NAFLD) and for healthy volunteers.

  Recruiting ContextVision AB · Seattle, Washington · NCT07270601

• Community-based study of fatty liver in older adults

  This study tests how common fatty liver disease is among people 65 and older and looks at lifestyle, environment, and genetics to see what factors influence it.

  Recruiting The Affiliated Hospital of Hangzhou Normal University · Hangzhou, Zhejiang · NCT07241195

• Multiple under-the-skin injections of B1344 for adults with NAFLD and NASH

  This trial will test whether repeated subcutaneous injections of an experimental drug called B1344 are safe and affect liver fat and related measures in adults with NAFLD or NASH.

  Recruiting Phase 1 Tasly Biopharmaceuticals Co., Ltd. · Beijing, Beijing Municipality and 4 other locations · NCT07128797

• Telehealth program for weight management and related health issues

  This study is testing a new telehealth program for weight management to see if it helps obese adults with type 2 diabetes and liver issues lose weight and improve their health better than traditional in-person programs.

  Recruiting Changi General Hospital · Singapore · NCT06890169

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.