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

Phase 2

Terminated

• Conditions: Heart Failure
• Interventions: Biological: Placebo; Biological: XXB750 Low dose; Biological: XXB750 High Dose; Biological: XXB750 Medium Dose; Drug: Sacubitril/valsartan

• Registration Number: NCT06142383
• Lead Sponsor: Novartis Pharmaceuticals

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.

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 Timeline

• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-21
• Study Start: 2023-12-12
• Status Verified: 2024-11
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 720

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Placebo	Placebo Treatment
Arm 2	XXB750 Low dose	XXB750 Low Dose
Arm 4	XXB750 High Dose	XXB750 High Dose
Arm 3	XXB750 Medium Dose	XXB750 Medium Dose
Arm 5	Sacubitril/valsartan	Sacubitril/valsartan, open label tablet

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (44)

SEC Clinical Research Research; 🇺🇸 Dothan, Alabama, United States

Heart Center Research Llc .; 🇺🇸 Huntsville, Alabama, United States

Pima Heart And Vascular Clin Rch Research; 🇺🇸 Tucson, Arizona, United States

Memorial Care Health System Memorialcare Long Beach; 🇺🇸 Long Beach, California, United States

Hartford Healthcare Headache Center Research; 🇺🇸 West Hartford, Connecticut, United States

Nature Coast Clinical Research LLC; 🇺🇸 Inverness, Florida, United States

Jacksonville Ctr For Clin Rea Main Centre; 🇺🇸 Jacksonville, Florida, United States

East Coast Institute for Research East Coast Inst for Res ECIR; 🇺🇸 Jacksonville, Florida, United States

Inpatient Research Clinical LLC; 🇺🇸 Miami Lakes, Florida, United States

Miami Clinical Research .; 🇺🇸 Miami, Florida, United States

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