A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

NCT07324616 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EDG-7500-106
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of liver function impairment versus participants with normal liver function. The safety of EDG-7500 in adult participants with different levels of liver function impairment will also be evaluated in this study.

Conditions

Hepatic Impairment (HI)

Keywords

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last)

  Pre-dose to day 10

• Area under the plasma concentration time-curve from time zero extrapolated to infinity (AUC0-inf)

  Pre-dose to day 10

• Maximum observed plasma concentration (Cmax)

  Pre-dose to day 10

Secondary Outcomes (1)

• Safety: incidence of treatment-emergent adverse events

  Up to 14 days of monitoring

Study Arms (3)

Healthy Adults

EXPERIMENTAL

Drug: EDG-7500

Mild Hepatic Impairment

EXPERIMENTAL

Drug: EDG-7500

Moderate Hepatic Impairment

EXPERIMENTAL

Drug: EDG-7500

Interventions

EDG-7500 DRUG

Single dose of EDG-7500

Healthy Adults; Mild Hepatic Impairment; Moderate Hepatic Impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Participants
• Adult, male or female, ≥ 18 years of age.
• Female and male participants must follow protocol-specified contraception guidance.
• Continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing.
• BMI ≥ 18.0 and ≤ 40.0 kg/m2 at screening.
• eGFR \>60 mL/min calculated using the 2021 CKD-EPI creatinine equation.
• Participants with Mild and Moderate Hepatic Impairment (HI)
• With the exception of HI, is in generally good health for study participation including the following:
• Pulse rate is ≥ 40 bpm and ≤ 110 bpm at screening.
• QTcF interval is ≤ 500 msec and has ECG findings considered normal or not clinically significant.
• Has impaired hepatic function as defined by the Child-Pugh classification for severity of liver disease and has a Child-Pugh score in line with one of the following HI cohorts at screening:
• Mild HI (Class A): Child-Pugh score of 5 to 6, inclusive.
• Moderate HI (Class B): Child-Pugh score of 7 to 9, inclusive.
• Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency.
• Participants with Normal Hepatic Function:

You may not qualify if:

• All Participants
• History or presence of alcohol or drug abuse within the past 1 year prior to dosing.
• Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating or breastfeeding.
• Positive urine or breath alcohol results at screening or check-in. Unable to refrain from or anticipates the use of any drugs.
• Positive results for HIV at screening.
• Donation of blood or significant blood loss within 56 days prior to dosing.
• Plasma donation within 7 days prior to dosing.
• Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to dosing.
• Participants with Mild and Moderate HI
• With the exception of HI, history or presence of clinically significant medical or psychiatric condition or disease, or any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study.
• History of severe complications of liver disease within the preceding 3 months of screening.
• Primary biliary cholangitis or biliary obstruction at screening.
• Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing.
• History of liver or other solid organ transplantation.
• Requires paracentesis more often than 2 times per month.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (2)

The University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Central Study Contacts

Edgewise Therapeutics, Inc.

CONTACT

720-262-7002; cardiacstudies@edgewisetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: January 26, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)