Trial | NCT03875183  Report issue

Title

Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    INL1 ...

  • Study Participants

    200
This is a multicenter, randomized, double-blind, placebo-controlled, dose-response trial in patients with chronic stable Heart Failure (HF) and reduced Left Ventricular Ejection Fraction (LVEF) to evaluate the efficacy and safety of three INL1 doses compared with placebo. Patients will be treated for approximately 12 weeks with one of three INL1 doses: 50 mg, 150 mg, 300 mg, or, placebo capsules, taken twice daily (BID).
Study Started
Jan 20
2020
Primary Completion
Dec 31
2022
Anticipated
Study Completion
Jan 31
2023
Anticipated
Last Update
Mar 31
2022

Drug INL1

Capsules

Other Placebo

Capsules

INL1 50mg BID Experimental

INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose

INL1 150 mg BID Experimental

INL1 150mg dose to be given twice daily using three 50mg capsules at each dose

INL1 300 mg BID Experimental

INL1 300mg dose to be given twice daily using three 100mg capsules at each dose

Placebo Placebo Comparator

Placebo dose to be given twice daily using 3 placebo capsules at each dose

Criteria 

Inclusion Criteria:

Clinical diagnosis of HF requiring chronic treatment of loop diuretics
Left Ventricular Ejection Fraction (LVEF) ≤ 40% at screening by echocardiography
N-Terminal-prohormone of Brain Natriuretic Peptide (NT-proBNP) ≥400 pg/mL at screening for patients without atrial fibrillation or atrial flutter, or, NT-proBNP ≥ 1,200 pg/mL at screening for patients with atrial fibrillation or atrial flutter
Treated for Heart Failure with stable, optimal pharmacological therapy
Acceptable screening echocardiographic image quality

Exclusion Criteria:

Female patients of childbearing potential
Patients with a New York Heart Association (NYHA) Class I or IV
Heart failure that is clearly caused by toxin / drug such as Adriamycin
Significant medical conditions or recent history suggesting the patient's study participation will potentially pose a major risk to patient's safety and well-being
Need for routine scheduled outpatient IV infusions for Heart Failure or scheduled ultrafiltration
History of rhabdomyolysis or history of autoimmune diseases
Severe renal disease
Hepatic disease
Pulmonary disease limiting exercise capacity
Atrial fibrillation with rapid ventricular response
Life expectancy of less than 6 months
Type 1 diabetes mellitus or Type 2 diabetes mellitus with very poor glycemic control
Patients with anemia
No Results Posted