VV-14303 for Non-Alcoholic Fatty Liver Disease
(RESTORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called VV-14303 for individuals with Metabolic dysfunction-associated steatohepatitis (MASH), a liver condition linked to metabolic issues like obesity and diabetes. The goal is to assess how different doses of VV-14303 affect this condition. Participants must have a biopsy-confirmed diagnosis of MASH and at least two metabolic risk factors, such as obesity, high blood pressure, or type 2 diabetes. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking research.
Is there any evidence suggesting that VV-14303 is likely to be safe for humans?
Without specific data on VV-14303, the trial phase can offer some insight into its safety. This trial is in the early stages, which primarily focus on safety. These stages assess how well participants tolerate the treatment and identify any side effects.
A treatment in these early stages may have some initial safety information, but it is still under careful study to ensure safety for participants. Participants might experience unknown side effects because the treatment hasn't undergone extensive testing yet.
Consult the trial organizers or a healthcare provider for the most detailed and specific safety information.12345Why do researchers think this study treatment might be promising for MASH?
Unlike the standard treatments for Non-Alcoholic Fatty Liver Disease, which often involve lifestyle changes and medications like vitamin E or pioglitazone, VV-14303 offers a fresh approach by targeting the disease at a molecular level. Researchers are excited about VV-14303 because it could provide a more direct and effective treatment by interfering with specific pathways involved in liver fat accumulation. This targeted action might lead to better outcomes with potentially fewer side effects, offering hope for patients who struggle with the limited effectiveness of current therapies.
What evidence suggests that VV-14303 might be an effective treatment for MASH?
Research suggests that VV-14303 might help treat metabolic dysfunction-associated steatohepatitis (MASH) by influencing gut bacteria and bile acid processing. In studies with mice, this treatment showed promise in protecting against non-alcoholic fatty liver disease by managing these factors. Gut bacteria play a crucial role in overall health, and bile acids aid in fat breakdown. By affecting these elements, VV-14303 might reduce liver fat and inflammation. Although early results are promising, further research is needed to confirm its effectiveness in humans.16789
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic fatty liver disease. Participants should not have other major health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Dose-escalation study to evaluate safety and efficacy of VV-14303 in participants with MASH
Treatment Part 2
Administration of VV-14303 at the dose determined from Part 1 to evaluate efficacy in participants with MASH
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VV-14303
Trial Overview
The study is testing a new medication called VV-14303 to see if it helps treat MASH. All participants will receive this treatment, and researchers will monitor its effects on liver health.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
VV-14303 will be administered at the dose determined from Part 1 (Cohorts 1, 2, and 3)
Dose #3 of VV-14303 will be administered
Dose #2 of VV-14303 will be administered
Dose #1 of VV-14303 will be administered
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kriya Therapeutics, Inc.
Lead Sponsor
Citations
1.
papers.ssrn.com
papers.ssrn.com/sol3/Delivery.cfm/040fc56b-da4d-4a28-81a8-a102c94eb964-MECA.pdf?abstractid\u003d7140074\u0026mirid\u003d1Gut microbiota-bile acid-intestinal FXR signaling mediates the anti
protect against non-alcoholic fatty liver disease via regulation of gut microbiota and bile acid. 850 metabolism in mice. Phytomedicine. 2024;133:155919. doi ...
Inhibition of store-operated calcium entry mitigates ...
Furthermore, viral infection, toxins, alcohol, and medication poisoning are major causes of liver diseases and associated death. ... fatty ...
3.
researchgate.net
researchgate.net/publication/385494686_Development_and_validation_of_a_model_for_predicting_who_can_benefit_from_multiple_TACE_in_HCC_patients(PDF) Development and validation of a model for ...
... alcoholic. fatty liver is the main cause in Europe and America [1, 2]. For early-stage HCC, radical treatment measures are mainly. used ...
Vincent Ho
10.1111/nmo.14303. PMID: 34913225. Contributors: Vincent Ho. Show more detail ... Liver Fibrosis in Non-Alcoholic Fatty Liver Disease. Journal of Clinical ...
Copper and Zinc Homeostasis: Lessons from Drosophila ...
Zn plays key roles in metabolism of CO2 and alcohol, immunological ... not in the optic lobes, salivary glands and fat body. In the adult nervous ...
Application of biodegradable microsphere injections
it is the only natural, degradable, safe, non-toxic, and environment-friendly vascular embolization agent commercially available in the world.
Published Research | OBGYN | Michigan State University
Non-malignant gynaecological disease and risk of cardiovascular or cerebrovascular disease: a systematic review and meta-analysis.
Integrated Science Assessment for Oxides of Nitrogen ...
These various lines of evidence 13 suggest that comorbidities in older adults could contribute to their higher risk of 14 NO2-related health effects.
NATIONAL FAMILY HEALTH SURVEY (NFHS-3) 2005–06
The survey was tasked with producing a) HIV prevalence estimates at the national level ・ robust estimates of population and health indicators for slum areas ...
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