56 Participants NeededMy employer runs this trial

VV-14303 for Non-Alcoholic Fatty Liver Disease

(RESTORE Trial)

Recruiting at 2 trial locations
VM
Overseen ByVP, Medical Affairs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I am able to understand and sign the consent form for this study.
Must be willing to refrain from donation of blood, plasma, platelets, eggs, or sperm during 12-month post-treatment follow-up
Previous history or presence of ≥2 metabolic risk factors: obesity (BMI ≥25 kg/m²), hypertension (BP ≥140/90 mmHg or on antihypertensive medication), dyslipidemia (triglycerides ≥150 mg/dL or HDL-C <40 mg/dL in men/<50 mg/dL in women or on lipid-lowering therapy), type 2 diabetes mellitus
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Exclusion Criteria

Prior participation in systemic experimental or investigational treatments within 6 weeks or 5 half-lives prior to Screening
I have not had major muscle injuries or ongoing symptoms in injection areas recently.
I have received gene therapy or participated in a gene therapy trial before.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Dose-escalation study to evaluate safety and efficacy of VV-14303 in participants with MASH

6 weeks

Treatment Part 2

Administration of VV-14303 at the dose determined from Part 1 to evaluate efficacy in participants with MASH

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

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

Group I: Part 2 doseExperimental Treatment1 Intervention
Group II: Part 1 Cohort 3, dose #3Experimental Treatment1 Intervention
Group III: Part 1 Cohort 2, dose #2Experimental Treatment1 Intervention
Group IV: Part 1 Cohort 1, dose #1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kriya Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
60+

Citations

Gut 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 ...

(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 ...