NCT05328752CompletedPhase 1
Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
A Randomized, Participant- and Investigator-blinded, Sponsor Open-label, Placebo-controlled, Single and Multiple Dose Study to Investigate the Safety and Tolerability of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
Source: ClinicalTrials.gov · Last updated 30 Sept 2025
Brief summary (registry, in English)
This is a multi-center, randomized, sponsor open-label, participant- and investigator-blinded, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 in HFrEF/HFmrEF.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 30 Mar 2022
- Start date
- 17 May 2022
- Primary completion date
- 18 Jan 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Heart failure
- NCT number
- NCT05328752
- EudraCT number
- 2021-006683-24
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 27
- From 17 May 2022 to the primary completion date, 18 Jan 2024
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute decompensated heart failure within 3 months prior to screening. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening
- Implantation of a CRT device within 3 months prior to screening or intent to implant a CRT during the study period
- Cohort 1 only: Treatment with sacubitril/valsartan currently or within 4 weeks from screening
- Cohort 2: Treatment with ACE inhibitor or ARB currently or within 4 weeks from screening
Other illness
- Hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to LV dilatation at screening
- History of severe pulmonary disease (e.g. COPD) requiring chronic supplemental oxygen therapy or pulmonary hypertension requiring pharmacology treatment at Screening
Lab values
- eGFR \<45 mL/min/1.73 m2 at screening
Other
- BMI \>40 kg/m2
- Other protocol-specific criteria may apply.
Who the study is looking for
- NYHA functional class II-III
- LVEF ≤ 50% documented at screening
- Systolic blood pressure 110 - 160 mmHg (cohort 1) or 105-160 mmHg (cohort 2), and heart rate between 50-90 beats per minute, inclusive
- Treatment with a stable dose of a beta blocker.
- Cohort 1: Treatment with a stable dose of ACE inhibitor or ARB
- Cohort 2: Treatment with a stable dose of sacubitril/valsartan.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Investigative Site Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Nature Coast Clinical Research LLC Coordinator of this site? Confirm its status | Inverness | United States | Unknown status |
| Jacksonville Ctr for Clin Rea Main Centre Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Fairview Health Services Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.