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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06142383

Collaborator

(none)

720

Enrollment

Arms

25.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Biological: Placebo Biological: XXB750 Low dose Biological: XXB750 Medium Dose Biological: XXB750 High Dose Drug: Sacubitril/valsartan	Phase 2

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

720 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Patients will receive either active XXB750 injection or a placebo injection that looks identical to the active injection. Sacubitril/valsartan will be administered in an open-label fashion

Primary Purpose:

Treatment

Official Title:

A Multi-center, Randomized, Placebo- and Active-controlled, Parallel-group, 24-week Proof of Concept and Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of XXB750 in Patients With Heart Failure

Anticipated Study Start Date :

Dec 14, 2023

Anticipated Primary Completion Date :

Dec 4, 2025

Anticipated Study Completion Date :

Jan 29, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 1 Placebo Treatment	Biological: Placebo S.C. Injection
Experimental: Arm 2 XXB750 Low Dose	Biological: XXB750 Low dose S.C. Injection
Experimental: Arm 3 XXB750 Medium Dose	Biological: XXB750 Medium Dose S.C. Injection
Experimental: Arm 4 XXB750 High Dose	Biological: XXB750 High Dose S.C. Injection
Active Comparator: Arm 5 Sacubitril/valsartan, open label tablet	Drug: Sacubitril/valsartan Tablet

Outcome Measures

Primary Outcome Measures

Change in log NT-proBNP from baseline to Week 16 [Baseline to Week 16]
To evaluate the efficacy and dose-response relationship of three XXB750 target dose levels compared to placebo in reducing NT-proBNP.

Secondary Outcome Measures

Change in log NT-proBNP from baseline to Week 16 [Baseline to Week 16]
To evaluate the efficacy of the highest and combined two highest XXB750 target dose levels compared to placebo and sacubitril/valsartan, respectively, in reducing NT-proBNP.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.