A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure
- Conditions
- Heart Failure
- Interventions
- Biological: PlaceboBiological: XXB750 Low doseBiological: XXB750 High DoseBiological: XXB750 Medium Dose
- Registration Number
- NCT06142383
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.
- Detailed Description
Eligible participants will be randomized to receive either subcutaneous (s.c.) XXB750 or placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 720
- Current symptom(s) of HF NYHA class II-III and LVEF < 50%
- Elevated NT-proBNP levels at screening.
- Receiving standard of care background HF therapy.
- Current acute decompensated HF or hospitalization for HF within 3 months prior to screening.
- Current symptomatic hypotension (for example dizziness/presyncope).
- K+ > 5.4 mmol/L at screening
- eGFR < 30 mL/min/1.73m2 at screening
Other protocol-specific criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Placebo Placebo Treatment Arm 2 XXB750 Low dose XXB750 Low Dose Arm 4 XXB750 High Dose XXB750 High Dose Arm 3 XXB750 Medium Dose XXB750 Medium Dose Arm 5 Sacubitril/valsartan Sacubitril/valsartan, open label tablet
- Primary Outcome Measures
Name Time Method Change in log NT-proBNP from baseline to Week 16 Baseline to Week 16 To evaluate the efficacy and dose-response relationship of three XXB750 target dose levels compared to placebo in reducing NT-proBNP.
- Secondary Outcome Measures
Name Time Method Change in log NT-proBNP from baseline to Week 16 Baseline to Week 16 To evaluate the efficacy of the highest and combined two highest XXB750 target dose levels compared to placebo and sacubitril/valsartan, respectively, in reducing NT-proBNP.
Trial Locations
- Locations (44)
SEC Clinical Research Research
🇺🇸Dothan, Alabama, United States
Heart Center Research Llc .
🇺🇸Huntsville, Alabama, United States
Pima Heart And Vascular Clin Rch Research
🇺🇸Tucson, Arizona, United States
Memorial Care Health System Memorialcare Long Beach
🇺🇸Long Beach, California, United States
Hartford Healthcare Headache Center Research
🇺🇸West Hartford, Connecticut, United States
Nature Coast Clinical Research LLC
🇺🇸Inverness, Florida, United States
Jacksonville Ctr For Clin Rea Main Centre
🇺🇸Jacksonville, Florida, United States
East Coast Institute for Research East Coast Inst for Res ECIR
🇺🇸Jacksonville, Florida, United States
Inpatient Research Clinical LLC
🇺🇸Miami Lakes, Florida, United States
Miami Clinical Research .
🇺🇸Miami, Florida, United States
Ormond Beach Clinical Research
🇺🇸Ormond Beach, Florida, United States
St Johns Center Research
🇺🇸Ponte Vedra, Florida, United States
East Coast Inst for Research LLC
🇺🇸Saint Augustine, Florida, United States
Cardiology Partners Clinical Research Institute
🇺🇸Wellington, Florida, United States
American Clinical Trials
🇺🇸Acworth, Georgia, United States
Reid Hosp And Hlth Care Services
🇺🇸Richmond, Indiana, United States
The Research Group Lewis Hargett Circle
🇺🇸Lexington, Kentucky, United States
Cambridge Medical Trials .
🇺🇸Alexandria, Louisiana, United States
Heart Clinic of Hammond .
🇺🇸Hammond, Louisiana, United States
Grace Research Llc .
🇺🇸Shreveport, Louisiana, United States
University of Maryland Research
🇺🇸Baltimore, Maryland, United States
Sinai Ctr Thrombois Res Drug Dev
🇺🇸Baltimore, Maryland, United States
Anderson Medical Research Main Center
🇺🇸Fort Washington, Maryland, United States
Revival Research Institute .
🇺🇸Troy, Michigan, United States
Troy Internal Medicine Research .
🇺🇸Troy, Michigan, United States
Fairview Health Services St Johns
🇺🇸Saint Paul, Minnesota, United States
Washington Univ School of Medicine
🇺🇸Saint Louis, Missouri, United States
St Louis Heart and Vascular .
🇺🇸Saint Louis, Missouri, United States
Clinilabs Inc Clinilabs
🇺🇸New York, New York, United States
Laurelton Heart Specialist PC Research
🇺🇸Rosedale, New York, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
University Of Cincinnati UCMC Facility Address
🇺🇸Cincinnati, Ohio, United States
NexGen Research
🇺🇸Lima, Ohio, United States
Prisma Health Research
🇺🇸Columbia, South Carolina, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Tennessee Center For Clinical Trials .
🇺🇸Tullahoma, Tennessee, United States
Cypress Heart and Vascular Center
🇺🇸Cypress, Texas, United States
Baylor University Medical Center Facility
🇺🇸Dallas, Texas, United States
John Peter Smith Hospital
🇺🇸Fort Worth, Texas, United States
Northwest Houston Cardiology PA Horizons Clin Resrch Group
🇺🇸Houston, Texas, United States
Grace Research .
🇺🇸Marshall, Texas, United States
Dominion Medical Associates
🇺🇸Richmond, Virginia, United States
Universal Research Group LLC Suite 202
🇺🇸Tacoma, Washington, United States
Novartis Investigative Site
🇬🇧East Yorkshire, United Kingdom