Phase 3: testing HSK31679 for MASH - Metabolic Dysfunction-Associated Steatohepatitis
A phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating the whether it is safe and how hard side effects are to live with of HSK31679 compared to dummy treatment (placebo) in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
Official registry: https://clinicaltrials.gov/study/NCT07581951 · Haisco Pharmaceutical Group Co., Ltd. · enrollment listed as 886
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are HSK31679, or Placebo. The registry lists allocation as randomized. A phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating the whether it is safe and how hard side effects are to live with of HSK31679 compared to dummy treatment (placebo) in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
They plan to enroll about 886 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)
Interventions: HSK31679, Placebo
Primary outcome (registry wording): Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52.
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Male and female adults ≥ 18 years of age
- Have at least one cardiometabolic risk factors at screening
- MRI-PDFF fat fraction ≥8%
- Body weight fluctuation \< 5% for at least 6 weeks before randomization
Who the registry excludes
- 1\. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening
- MELD score ≥12 due to hepatic disease。
- Received medication therapy that may induce MAFLD/MASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy)
- Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study
- Chronic liver diseases other than NASH
- Active autoimmune disease. 9.Serum ALT \> 250 U/L. 10.Active, serious medical disease with a likely life expectancy \< 2 years
Public study contact (from the registry)
fangqiong li
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (recruiting)
FAQ about this NCT record
Is NCT07581951 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07581951?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07581951?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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