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

Recruiting
18 years of age
Both
Phase 2

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Overview

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.

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

Eligibility

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.

Study details

Heart Failure

NCT06142383

Novartis Pharmaceuticals

15 June 2024

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