Clinical trial NCT06142383: A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Heart failure
randomized
double-blind
dose finding
XXB750
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in log NT-proBNP from baseline to Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change in log NT-proBNP from baseline to Week 16
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Dothan
country: United States
facility: SEC Clinical Research Research
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research Llc .
state: Alabama
city: Tucson
country: United States
facility: Pima Heart And Vascular Clin Rch Research
state: Arizona
city: Long Beach
country: United States
facility: Memorial Care Health System Memorialcare Long Beach
state: California
city: West Hartford
country: United States
facility: Hartford Healthcare Headache Center Research
state: Connecticut
city: Inverness
country: United States
facility: Nature Coast Clinical Research LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Ctr For Clin Rea Main Centre
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research East Coast Inst for Res ECIR
state: Florida
city: Miami Lakes
country: United States
facility: Inpatient Research Clinical LLC
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research .
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Research
state: Florida
city: Ponte Vedra
country: United States
facility: St Johns Center Research
state: Florida
city: Saint Augustine
country: United States
facility: East Coast Inst for Research LLC
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Acworth
country: United States
facility: American Clinical Trials
state: Georgia
city: Richmond
country: United States
facility: Reid Hosp And Hlth Care Services
state: Indiana
city: Lexington
country: United States
facility: The Research Group Lewis Hargett Circle
state: Kentucky
city: Alexandria
country: United States
facility: Cambridge Medical Trials .
state: Louisiana
city: Hammond
country: United States
facility: Heart Clinic of Hammond .
state: Louisiana
city: Shreveport
country: United States
facility: Grace Research Llc .
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Research
state: Maryland
city: Baltimore
country: United States
facility: Sinai Ctr Thrombois Res Drug Dev
state: Maryland
city: Fort Washington
country: United States
facility: Anderson Medical Research Main Center
state: Maryland
city: Troy
country: United States
facility: Revival Research Institute .
state: Michigan
city: Troy
country: United States
facility: Troy Internal Medicine Research .
state: Michigan
city: Saint Paul
country: United States
facility: Fairview Health Services St Johns
state: Minnesota
city: Saint Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: St Louis Heart and Vascular .
state: Missouri
city: New York
country: United States
facility: Clinilabs Inc Clinilabs
state: New York
city: Rosedale
country: United States
facility: Laurelton Heart Specialist PC Research
state: New York
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University Of Cincinnati UCMC Facility Address
state: Ohio
city: Lima
country: United States
facility: NexGen Research
state: Ohio
city: Columbia
country: United States
facility: Prisma Health Research
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Tullahoma
country: United States
facility: Tennessee Center For Clinical Trials .
state: Tennessee
city: Cypress
country: United States
facility: Cypress Heart and Vascular Center
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center Facility
state: Texas
city: Fort Worth
country: United States
facility: John Peter Smith Hospital
state: Texas
city: Houston
country: United States
facility: Northwest Houston Cardiology PA Horizons Clin Resrch Group
state: Texas
city: Marshall
country: United States
facility: Grace Research .
state: Texas
city: Richmond
country: United States
facility: Dominion Medical Associates
state: Virginia
city: Tacoma
country: United States
facility: Universal Research Group LLC Suite 202
state: Washington
city: Blagoevgrad
country: Bulgaria
facility: Novartis Investigative Site
city: Gabrovo
country: Bulgaria
facility: Novartis Investigative Site
city: Kyustendil
country: Bulgaria
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Luoyang
country: China
facility: Novartis Investigative Site
state: Henan
city: Changzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Changchun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Shanghai
country: China
facility: Novartis Investigative Site
state: Shanghai
city: Xian
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Jinan
country: China
facility: Novartis Investigative Site
city: Brno
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Liberec
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Hvidovre
country: Denmark
facility: Novartis Investigative Site
city: Roskilde
country: Denmark
facility: Novartis Investigative Site
city: Beziers Cedex
country: France
facility: Novartis Investigative Site
city: Chambray les Tours
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Paris cedex 10
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Saint Herblain - Nantes
country: France
facility: Novartis Investigative Site
city: Toulouse 4
country: France
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
state: Nordrhein Westfalen
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Coburg
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gladbeck
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Neuwied
country: Germany
facility: Novartis Investigative Site
city: Papenburg
country: Germany
facility: Novartis Investigative Site
city: Schwaebisch Hall
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
state: Pest Megye
city: Balatonfured
country: Hungary
facility: Novartis Investigative Site
city: Mosanmagyarovar
country: Hungary
facility: Novartis Investigative Site
city: Bikaner
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Belgavi
country: India
facility: Novartis Investigative Site
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Pordenone
country: Italy
facility: Novartis Investigative Site
state: PN
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Trieste
country: Italy
facility: Novartis Investigative Site
state: TS
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Koriyama
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Matsumoto
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Kawaguchi-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
state: Zuid Holland
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Heerlen
country: Netherlands
facility: Novartis Investigative Site
city: Leeuwarden
country: Netherlands
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Vila Nova De Gaia
country: Portugal
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Svidnik
country: Slovakia
facility: Novartis Investigative Site
city: Huelva
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Utrera
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Santiago De Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: East Yorkshire
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: