A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure
NCT ID: NCT06142383
Last Updated: 2025-12-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
136 participants
INTERVENTIONAL
2023-12-12
2024-11-01
Brief Summary
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Detailed Description
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The study planned to randomize adult participants with LVEF \< 50% receiving ACEI/ARB/ARNI and guideline-recommended HF therapies for HFrEF or HFmrEF to three XXB750 target dose levels; a cohort of participants treated with ACEI/ARB before the study was randomized to be converted to open-label sacubitril/valsartan in place of their pre-study ACEI/ARB. A total of 720 participants were planned to be randomized in this study.
Due to safety concerns, in August 2024 the study was halted and dosing of all double-blind injectable medication of XXB750 and matching Placebo was suspended until further notice. All randomized participants actively involved in the study continued to attend study visits as per the study schedule and underwent all study procedures. This included safety, pharmacokinetic, antidrug antibody, and biomarker biological sample collections, physical examinations, and reporting of adverse events. As directed above, injectable study medication (i.e., XXB750 and its matching Placebo) was not administered. On 26-Sep-2024, Novartis made the decision to terminate the study due to safety findings and DMC recommendation.
Due to the early study termination, all participants who had been randomized to receive XXB750 or Placebo were followed up for 12 weeks after they received the last dose which is in accordance with the originally planned follow-up duration as per protocol. Participants who were randomized to the open-label treatment arm 5 and received sacubitril/valsartan as study medication were not further followed up after discontinuation of the open-label study medication. Sacubitril/valsartan is authorized in all participating countries and was, within this study, used as a comparator within the respective labels only. Hence, an additional follow-up for the safety of the participants was not performed; and the investigator could treat the participant with standard-of-care treatment (which includes sacubitril/valsartan) as per his/her clinical judgment.
To help guard the safety of study participants, randomization initially excluded the planned highest target dose of 240 mg XXB750 (i.e., arm 4). The study was terminated prematurely prior to the pre-planned early safety analysis due to an imbalance in worsening heart failure events among participants randomized to XXB750 60 mg and 120 mg. Thus, no participants were exposed to the planned highest target dose of 240 mg every 4 weeks.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
XXB750 Placebo
Placebo
S.C. Injection
Arm 2
XXB750 60 mg
XXB750 Low dose
S.C. Injection
Arm 3
XXB750 120 mg
XXB750 Medium Dose
S.C. Injection
Arm 4
XXB750 240 mg
XXB750 High Dose
S.C. Injection
Arm 5
Sacubitril/valsartan, open label tablet, 97/103 mg bid (Sac/Val)
Sacubitril/valsartan
Tablet
Interventions
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Placebo
S.C. Injection
XXB750 Low dose
S.C. Injection
XXB750 Medium Dose
S.C. Injection
XXB750 High Dose
S.C. Injection
Sacubitril/valsartan
Tablet
Eligibility Criteria
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Inclusion Criteria
* Elevated NT-proBNP levels at screening.
* Receiving standard of care background HF therapy.
Exclusion Criteria
* Current symptomatic hypotension (for example dizziness/presyncope).
* K+ \> 5.4 mmol/L at screening
* eGFR \< 30 mL/min/1.73m2 at screening
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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SEC Clinical Research
Dothan, Alabama, United States
Heart Center Research Llc
Huntsville, Alabama, United States
Nature Coast Clinical Research LLC
Inverness, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
American Clinical Trials
Acworth, Georgia, United States
The Research Group
Lexington, Kentucky, United States
Heart Clinic of Hammond
Hammond, Louisiana, United States
Anderson Medical Research
Ft. Washington, Maryland, United States
Revival Research Institute
Troy, Michigan, United States
Aultman Hospital
Canton, Ohio, United States
NexGen Research
Lima, Ohio, United States
Tennessee Center For Clinical Trials
Tullahoma, Tennessee, United States
Dominion Medical Associates
Richmond, Virginia, United States
Novartis Investigative Site
Blagoevgrad, , Bulgaria
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Gabrovo, , Bulgaria
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Kyustendil, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Xian, Shanxi, China
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Berlin, , Germany
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Cologne, , Germany
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Gladbeck, , Germany
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Kiel, , Germany
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Ludwigshafen, , Germany
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Papenburg, , Germany
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Schwäbisch Hall, , Germany
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Budapest, Pest County, Hungary
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Balatonfüred, , Hungary
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Belagavi, Karnataka, India
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Bikaner, Rajasthan, India
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Brescia, BS, Italy
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Messina, ME, Italy
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Milan, MI, Italy
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Pordenone, PN, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Trieste, TS, Italy
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Maebashi, Gunma, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Matsumoto, Nagano, Japan
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Lisbon, , Portugal
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Vila Nova de Gaia, , Portugal
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Bardejov, Slovakia, Slovakia
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Košice, Slovakia, Slovakia
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Martin, Slovakia, Slovakia
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Nitra, Slovakia, Slovakia
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Prešov, Slovakia, Slovakia
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Svidník, Slovakia, Slovakia
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Santiago Compostela, A Coruna, Spain
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Huelva, Andalusia, Spain
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Majadahonda, Madrid, Spain
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Las Palmas GC, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Taichung, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2023-504678-39-00
Identifier Type: OTHER
Identifier Source: secondary_id
CXXB750A12201
Identifier Type: -
Identifier Source: org_study_id