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

JRCT ID: jRCT2031230649

Registered date:22/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure
• Date of first enrollment: 01/03/2024
• Target sample size: 18
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

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
Treatment arm5: Sacubitril/valsartan at target doses of 97/103 mg bid

Outcome(s)

• Primary Outcome: Change in log NT-proBNP from baseline

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Iwasaki Ryohei
• Secondary ID(s): NCT06142383