NCT05328752

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2022

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

March 30, 2022

Last Update Submit

September 24, 2025

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)or Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Keywords

heart failurereduced ejection fractionmildly reduced ejection fractionHFrEFHFmrEFXXB750

Outcome Measures

Primary Outcomes (1)

  • Adverse events, which may include abnormal vital signs, safety lab tests, or ECG parameters that induce clinical signs or symptoms, are considered clinically significant or require therapy

    To evaluate the safety and tolerability of XXB750 in adult participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF).

    91 days (Cohort 1), 146 days (Cohort 2)

Secondary Outcomes (8)

  • Pharmacokinetics parameters Tmax

    91 days (Cohort 1), 146 days (Cohort 2)

  • Pharmacokinetics parameters Cmax

    91 days (Cohort 1), 146 days (Cohort 2)

  • Pharmacokinetics parameters AUClast for Cohort 1

    91 days

  • Pharmacokinetics parameters AUCinf for Cohort 1

    91 days

  • Pharmacokinetics parameters Vz/F

    91 days (Cohort 1), 146 days (Cohort 2)

  • +3 more secondary outcomes

Study Arms (4)

XXB750 Cohort 1

EXPERIMENTAL

XXB750, single dose

Drug: XXB750

Placebo Cohort 1

PLACEBO COMPARATOR

Placebo, single dose

Drug: Placebo

XXB750 Cohort 2

EXPERIMENTAL

XXB750, multiple doses

Drug: XXB750

Placebo Cohort 2

PLACEBO COMPARATOR

Placebo, multiple doses

Drug: Placebo

Interventions

XXB750DRUG

XXB750

XXB750 Cohort 1XXB750 Cohort 2
PlaceboDRUG

Placebo

Placebo Cohort 1Placebo Cohort 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to LV dilatation at screening
  • Implantation of a CRT device within 3 months prior to screening or intent to implant a CRT during the study period
  • History of severe pulmonary disease (e.g. COPD) requiring chronic supplemental oxygen therapy or pulmonary hypertension requiring pharmacology treatment at Screening
  • eGFR \<45 mL/min/1.73 m2 at screening
  • 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
  • BMI \>40 kg/m2
  • Other protocol-specific criteria may apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nature Coast Clinical Research LLC

Inverness, Florida, 34452, United States

Location

Jacksonville Ctr for Clin Rea Main Centre

Jacksonville, Florida, 32216, United States

Location

Fairview Health Services .

Saint Paul, Minnesota, 55102, United States

Location

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Site will have masked and unmasked investigators. An unmasked investigator will prepare and administer dose while a masked investigator will perform all assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, placebo-controlled safety study of XXB750
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 14, 2022

Study Start

May 17, 2022

Primary Completion

January 18, 2024

Study Completion

January 18, 2024

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)US(3)