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

• Status: Recruiting
• Trial end date: 2025-12-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

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.