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

Last updated: November 26, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

2

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

XXB750 High Dose

XXB750 Low dose

XXB750 Medium Dose

Clinical Study ID

NCT06142383
CXXB750A12201
2023-504678-39-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Current acute decompensated HF or hospitalization for HF within 3 months prior toscreening.

  • 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

Total Participants: 136
Treatment Group(s): 5
Primary Treatment: XXB750 High Dose
Phase: 2
Study Start date:
December 12, 2023
Estimated Completion Date:
November 01, 2024

Study 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

Connect with a study center

  • Novartis Investigative Site

    Blagoevgrad, 270 0
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Kyustendil, 2500
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Sofia, 1709
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Varna, 9010
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Novartis Investigative Site

    Luoyang, Henan 471002
    China

    Site Not Available

  • Novartis Investigative Site

    Changzhou, Jiangsu 213004
    China

    Site Not Available

  • Novartis Investigative Site

    Changchun, Jilin 130041
    China

    Site Not Available

  • Novartis Investigative Site

    Shenyang, Liaoning 110003
    China

    Site Not Available

  • Novartis Investigative Site

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Novartis Investigative Site

    Xian, Shanxi 710061
    China

    Site Not Available

  • Novartis Investigative Site

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Novartis Investigative Site

    Tianjin, Tianjin 300121
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100029
    China

    Site Not Available

  • Novartis Investigative Site

    Jinan, 250012
    China

    Site Not Available

  • Novartis Investigative Site

    Brno, Czech Republic 60200
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Liberec, 46063
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Praha, 12808
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Herlev, DK 2730
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Roskilde, 4000
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Beziers Cedex, 34525
    France

    Site Not Available

  • Novartis Investigative Site

    Chambray les Tours, 37170
    France

    Site Not Available

  • Novartis Investigative Site

    Creteil, 94010
    France

    Site Not Available

  • Novartis Investigative Site

    Montpellier, 34295
    France

    Site Not Available

  • Novartis Investigative Site

    Paris cedex 10, 75010
    France

    Site Not Available

  • Novartis Investigative Site

    Rennes, 35033
    France

    Site Not Available

  • Novartis Investigative Site

    Rouen, 76031
    France

    Site Not Available

  • Novartis Investigative Site

    Saint Herblain - Nantes, 44093
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse 4, 31054
    France

    Site Not Available

  • Novartis Investigative Site

    Essen, Nordrhein Westfalen 45355
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, Sachsen 01099
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 10787
    Germany

    Site Not Available

  • Novartis Investigative Site

    Coburg, 96450
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gladbeck, 45968
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kiel, 24105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 51065
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04289
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ludwigshafen, 67067
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neuwied, 56564
    Germany

    Site Not Available

  • Novartis Investigative Site

    Papenburg, 26871
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schwaebisch Hall, 74523
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stuttgart, 70376
    Germany

    Site Not Available

  • Novartis Investigative Site

    Budapest, Pest Megye 1134
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Balatonfured, 8230
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Mosanmagyarovar, 9200
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Bikaner, Rajasthan 334003
    India

    Site Not Available

  • Novartis Investigative Site

    Belgavi, 590010
    India

    Site Not Available

  • Novartis Investigative Site

    Ancona, AN 60128
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bergamo, BG 24127
    Italy

    Site Not Available

  • Novartis Investigative Site

    Brescia, BS 25123
    Italy

    Site Not Available

  • Novartis Investigative Site

    Cona, FE 44100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Messina, ME 98125
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Padova, PD 35128
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pisa, PI 56126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pordenone, PN 33170
    Italy

    Site Not Available

  • Novartis Investigative Site

    Reggio Emilia, RE 42123
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma, RM 00161
    Italy

    Site Not Available

  • Novartis Investigative Site

    Trieste, TS 34149
    Italy

    Site Not Available

  • Novartis Investigative Site

    Napoli, 80131
    Italy

    Site Not Available

  • Novartis Investigative Site

    Koriyama, Fukushima 963-8501
    Japan

    Site Not Available

  • Novartis Investigative Site

    Maebashi city, Gunma 371 8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawasaki-city, Kanagawa 216-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sagamihara, Kanagawa 252-0375
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsumoto, Nagano 390-8621
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kawaguchi-city, Saitama 333-0842
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hachioji, Tokyo 192-0918
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hachioji-city, Tokyo 192-0918
    Japan

    Site Not Available

  • Novartis Investigative Site

    Itabashi-ku, Tokyo 173-8610
    Japan

    Site Not Available

  • Novartis Investigative Site

    Rotterdam, Zuid Holland 3015 GD
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Heerlen, 6419 PC
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Nijmegen, 6500HB
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Lisboa, 1495 005
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Vila Nova De Gaia, 4434 502
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Bardejov, 085 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Kosice, 040 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Martin, 036 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Nitra, 949 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Nove Zamky, 940 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Presov, 080 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Svidnik, 089 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Huelva, Andalucia 21005
    Spain

    Site Not Available

  • Novartis Investigative Site

    Malaga, Andalucia 29010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Sevilla, Andalucia 41014
    Spain

    Site Not Available

  • Novartis Investigative Site

    Utrera, Andalucia 41710
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Santiago De Compostela, Galicia 15706
    Spain

    Site Not Available

  • Novartis Investigative Site

    El Palmar, Murcia 30120
    Spain

    Site Not Available

  • Novartis Investigative Site

    Alicante, 03700
    Spain

    Site Not Available

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28041
    Spain

    Site Not Available

  • Novartis Investigative Site

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Taichung, 40447
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Tainan, 71004
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Taipei, 11217
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    East Yorkshire, HU16 5JQ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Dothan, Alabama 36305
    United States

    Active - Recruiting

  • SEC Clinical Research Research

    Dothan, Alabama 36305
    United States

    Site Not Available

  • Heart Center Research Llc .

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Pima Heart And Vascular Clin Rch .

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Pima Heart And Vascular Clin Rch Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Memorial Care Health System Memorialcare Long Beach

    Long Beach, California 90806
    United States

    Site Not Available

  • Hartford Healthcare Headache Center Research

    West Hartford, Connecticut 06109
    United States

    Site Not Available

  • Nature Coast Clinical Research LLC

    Inverness, Florida 34452
    United States

    Site Not Available

  • Novartis Investigative Site

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • East Coast Institute for Research East Coast Inst for Res ECIR

    Jacksonville, Florida 32223
    United States

    Site Not Available

  • Jacksonville Ctr For Clin Rea Main Centre

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novartis Investigative Site

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Miami Clinical Research .

    Miami, Florida 33155
    United States

    Site Not Available

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Novartis Investigative Site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Ormond Beach Clinical Research

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Novartis Investigative Site

    Ponte Vedra, Florida 32801
    United States

    Active - Recruiting

  • St Johns Center Research

    Ponte Vedra, Florida 32801
    United States

    Site Not Available

  • East Coast Inst for Research LLC

    Saint Augustine, Florida 32086
    United States

    Site Not Available

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida 33449
    United States

    Site Not Available

  • American Clinical Trials

    Acworth, Georgia 30101
    United States

    Site Not Available

  • Novartis Investigative Site

    Acworth, Georgia 30101
    United States

    Active - Recruiting

  • Reid Hosp And Hlth Care Services

    Richmond, Indiana 47374
    United States

    Site Not Available

  • The Research Group Lewis Hargett Circle

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Cambridge Medical Trials .

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Heart Clinic of Hammond .

    Hammond, Louisiana 70403
    United States

    Site Not Available

  • Grace Research Llc .

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Novartis Investigative Site

    Shreveport, Louisiana 71101
    United States

    Active - Recruiting

  • Sinai Ctr Thrombois Res Drug Dev

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • University of Maryland Research

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Anderson Medical Research Main Center

    Fort Washington, Maryland 20744
    United States

    Site Not Available

  • Novartis Investigative Site

    Fort Washington, Maryland 20744
    United States

    Active - Recruiting

  • Henry Ford Health Research

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Revival Research Institute .

    Troy, Michigan 48084
    United States

    Site Not Available

  • Troy Internal Medicine Research .

    Troy, Michigan 48098
    United States

    Site Not Available

  • Fairview Health Services St Johns

    Saint Paul, Minnesota 55103
    United States

    Site Not Available

  • St Louis Heart and Vascular .

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • Washington Univ School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Clinilabs Inc Clinilabs

    New York, New York 10019
    United States

    Site Not Available

  • Laurelton Heart Specialist PC Research

    Rosedale, New York 11422
    United States

    Site Not Available

  • Aultman Hospital

    Canton, Ohio 44710
    United States

    Site Not Available

  • University Of Cincinnati UCMC Facility Address

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • NexGen Research

    Lima, Ohio 45805
    United States

    Site Not Available

  • Prisma Health Research

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Novartis Investigative Site

    Tullahoma, Tennessee 37388
    United States

    Active - Recruiting

  • Tennessee Center For Clinical Trials .

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • Cypress Heart and Vascular Center

    Cypress, Texas 77429
    United States

    Site Not Available

  • Baylor University Medical Center Facility

    Dallas, Texas 75246
    United States

    Site Not Available

  • John Peter Smith Hospital

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Northwest Houston Cardiology PA Horizons Clin Resrch Group

    Houston, Texas 77070
    United States

    Site Not Available

  • Grace Research .

    Marshall, Texas 75670
    United States

    Site Not Available

  • Novartis Investigative Site

    Marshall, Texas 75670
    United States

    Active - Recruiting

  • Dominion Medical Associates

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Novartis Investigative Site

    Richmond, Virginia 23219
    United States

    Active - Recruiting

  • Universal Research Group LLC Suite 202

    Tacoma, Washington 98405
    United States

    Site Not Available

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