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

Last Update: Jun 11, 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:

NCT06142383

Novartis Reference Number:CXXB750A12201

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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

Condition

Heart Failure

Phase

Phase2

Overall Status

Recruiting

Number of Participants

720

Start Date

Dec 12, 2023

Completion Date

Dec 22, 2025

Gender

All

Age(s)

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

Recruiting

Hammond,Louisiana,70403,United States

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

Study Description

Interventions

Placebo

Sacubitril/valsartan

XXB750 High Dose

XXB750 Low dose

XXB750 Medium Dose

Eligibility Criteria

Study Location

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Heart Clinic of Hammond .

Juliana Roberts

Ghiath Mikdadi

Nature Coast Clinical Research LLC

Donald Bowen

Rafik Abadier

St Louis Heart and Vascular .

Mohammad Tahir

Amber Mica

Clinical Research of Rock Hill

Michael Denenberg

Treacy McTier

Grace Research .

William Eaves

Kristen Terry

Laurelton Heart Specialist PC Research

Bomi Odumosu

Olakunle Akinboboye

Revival Research Institute .

Khalida Makin

Qaiser Shafiq

American Clinical Trials

Iasia Williams

Chinedu Nweke

Universal Research Group LLC Suite 202

Sabrina Benjamin

Iliana Mcdaniel

East Coast Inst for Research LLC

Ferris George

Inpatient Research Clinical LLC

Alexis Gutierrez

Ormond Beach Clinical Research

Dinesh Arab

Taylor Lenholt

Tennessee Center For Clinical Trials .

Bethany Jernigan

Dinesh Gupta

Grace Research Llc .

Anil Chhabra

Taylor Moore

Anderson Medical Research Main Center

Felton Anderson

Washington Univ School of Medicine

Amy Ronsick

Greg Ewald

East Coast Institute for Research East Coast Inst for Res ECIR

Jerry W Chandler

Leann Petschonek

NexGen Research

Nneamaka Ezema

Nonso Ezema

Cypress Heart and Vascular Center

Fadi Alameddine

Aultman Hospital

Ataul Qureshi