Last Update: Aug 02, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CXXB750A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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

Heart Failure
Phase2
Recruiting
720
Dec 12, 2023
Dec 22, 2025
All
18 Years - (Adult, Older Adult)

Interventions

Biological

Placebo

S.C. Injection
Drug

Sacubitril/valsartan

Tablet
Biological

XXB750 High Dose

S.C. Injection
Biological

XXB750 Low dose

S.C. Injection
Biological

XXB750 Medium Dose

S.C. Injection

Eligibility 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.

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals