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

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

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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