EDG-7500 for Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a new treatment, EDG-7500, behaves in the blood and its safety for individuals with varying levels of liver disease. The trial compares results from participants with mild or moderate liver impairment to those with normal liver function. Participants should be non-smokers or moderate smokers and generally in good health. Those with liver problems must have stable liver disease without recent severe episodes. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have used antiviral or immune modulating therapy for hepatitis within 90 days before the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that EDG-7500 is likely to be safe for humans?
Studies have shown that EDG-7500 was well-tolerated in healthy people. In a previous study, participants did not experience serious side effects. Reports from another trial indicated that EDG-7500 was safe to use, even when it lowered pressure in the heart muscle without affecting heart function. Since this trial is in its early phase, it focuses on assessing safety in healthy adults and those with liver issues. The goal is to monitor for any side effects and ensure the treatment is safe for everyone involved.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about EDG-7500 for liver disease because it offers a fresh approach compared to existing treatments like antiviral medications and liver transplants. Unlike these standard options, EDG-7500 is designed to potentially target the underlying mechanisms of liver damage directly, which could lead to better outcomes in managing liver impairment. This innovative approach could mean more effective treatment with fewer side effects, making it a promising candidate for improving liver health and quality of life for patients with varying degrees of hepatic impairment.
What evidence suggests that EDG-7500 might be an effective treatment for liver disease?
Research has shown that EDG-7500 was well-tolerated in past studies. One study demonstrated its ability to treat heart-related issues without harming heart function. In this trial, researchers are studying EDG-7500 for its effects on liver disease across various participant groups, including healthy adults and those with mild or moderate hepatic impairment. Its well-tolerated nature is encouraging. EDG-7500 targets specific pathways that may improve liver function. Early results suggest potential effectiveness, but further research is needed to confirm its benefits for liver conditions.12345
Are You a Good Fit for This Trial?
Adults over 18 with varying levels of liver function, including those with mild to moderate hepatic impairment, can join this trial. Participants must be non-smokers or moderate smokers, have a BMI between 18 and 40 kg/m2, and normal kidney function. They should also agree to follow contraception guidelines.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of EDG-7500
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EDG-7500
Trial Overview
The study is testing EDG-7500 in adults to see how different levels of liver health affect the drug's presence in the blood after one dose. It will compare results from those with normal liver function to those with impaired liver function.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edgewise Therapeutics, Inc.
Lead Sponsor
Citations
A Study to Evaluate EDG-7500 in Adults With Hepatic ...
The safety of EDG-7500 in adult participants with different levels of liver function impairment will also be evaluated in this study. Official ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/815347d763b81093/nct07324616-edg-7500-pharmacokinetics-impaired-normal-hepatic-functionA Study to Evaluate EDG-7500 in Adults With Hepatic ...
The safety of EDG-7500 in adult participants with different levels of liver function impairment will also be evaluated in this study. Detailed ...
EDG-7500 for Liver Disease · Info for Participants
The study is testing EDG-7500 in adults to see how different levels of liver health affect the drug's presence in the blood after one dose. It will compare ...
A Study to Evaluate EDG-7500 in Adults With Hepatic ...
The safety of EDG-7500 in adult participants with different levels of liver function impairment will also be evaluated in this study. Enrollment.
EDG-7500 Achieves Positive Phase 2 Results in ...
EDG-7500 was well-tolerated in healthy patients in Phase 1 while achieving gradient relief without LVEF reductions in the Phase 2 CIRRUS-HCM trial.
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