Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
Purpose
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).
Conditions
- Heart Failure
- Reduced Ejection Fraction
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental INL1 50mg BID |
INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose |
|
|
Experimental INL1 150 mg BID |
INL1 150mg dose to be given twice daily using three 50mg capsules at each dose |
|
|
Experimental INL1 300 mg BID |
INL1 300mg dose to be given twice daily using three 100mg capsules at each dose |
|
|
Placebo Comparator Placebo |
Placebo dose to be given twice daily using 3 placebo capsules at each dose |
|
Recruiting Locations
More Details
- NCT ID
- NCT03875183
- Status
- Unknown status
- Sponsor
- Innolife Co., Ltd.