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A proof-of-concept and dose-finding study of XXB750 in patients with heart failure

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 - CXXB750A12201

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230649
Enrollment
18
Registered
2024-02-22
Start date
2024-03-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Treatment arm1: Placebo matching XXB750 Treatment arm2: XXB750 60 mg target dose Treatment arm3: XXB750 120 mg target dose Treatment arm4: XXB750 240 mg target dose in one of two up-titration regimens

Sponsors

Maruyama Hideki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Change in log NT-proBNP from baseline

Countries

Japan, United States

Contacts

Public ContactHideki Maruyama

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026