Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588699
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Digoxin in NASH CODIN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Trial of Oral Digoxin in NASH CODIN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CODIN
Brief Summary:
Nonalcoholic steatohepatitis NASH is a severe subtype of nonalcoholic fatty liver disease NAFLD which affects 1 in 3 Americans The mainstay of treatment for NASH which was recently renamed metabolic associated steatohepatitis MASH involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension hyperlipidemia and diabetes mellitus There is thus a substantial unmet need for pharmacological therapies that are effective for treatment of NASH especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis thus supporting the repurposing of digoxin as treatment for NASH
Detailed Description:
Prospective randomized double-blind placebo-controlled single center trial of digoxin in patients with nonalcoholic steatohepatitis NASH
Primary objective
To compare the effect of digoxin oral administered once daily QD either as titration-based or weight-based dose versus placebo on histologic resolution of NASH
Key secondary objectives
To investigate the effect of digoxin oral administered once daily QD either as titration-based or weight-based dose compared to placebo on histologic imaging and biochemical markers of NASH and to assess the safety and tolerability of digoxin compared to placebo
Primary objective
To compare the effect of digoxin oral administered once daily QD either as titration-based or weight-based dose versus placebo on histologic resolution of NASH
Key secondary objectives
To investigate the effect of digoxin oral administered once daily QD either as titration-based or weight-based dose compared to placebo on histologic imaging and biochemical markers of NASH and to assess the safety and tolerability of digoxin compared to placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None