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Cardiology Partners Clinical Research Institute | Wellington Office

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A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure

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Novartis

Status and phase

Enrolling
Phase 2

Conditions

Heart Failure

Treatments

Biological: XXB750 High Dose
Drug: Sacubitril/valsartan
Biological: XXB750 Medium Dose
Biological: Placebo
Biological: XXB750 Low dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT06142383
CXXB750A12201
2023-504678-39-00 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

720 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

720 participants in 5 patient groups, including a placebo group

Arm 1
Placebo Comparator group
Description:
Placebo Treatment
Treatment:
Biological: Placebo
Arm 2
Experimental group
Description:
XXB750 Low Dose
Treatment:
Biological: XXB750 Low dose
Arm 3
Experimental group
Description:
XXB750 Medium Dose
Treatment:
Biological: XXB750 Medium Dose
Arm 4
Experimental group
Description:
XXB750 High Dose
Treatment:
Biological: XXB750 High Dose
Arm 5
Active Comparator group
Description:
Sacubitril/valsartan, open label tablet
Treatment:
Drug: Sacubitril/valsartan

Trial contacts and locations

146

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Central trial contact

Novartis Pharmaceuticals; Novartis Pharmaceuticals

Data sourced from clinicaltrials.gov

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