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NCT05562934

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.

Completed Phase 2 Results posted Last updated 12 January 2026
What this trial tests

Phase 2 trial testing XXB750 drug in Resistant Hypertension in 189 participants. Completed in 27 August 2024.

Timeline
8 November 2022
Primary endpoint
2 July 2024
27 August 2024

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment189
Start date8 November 2022
Primary completion2 July 2024
Estimated completion27 August 2024
Sites78 locations across France, Italy, Japan, Netherlands, Slovakia, Austria, Taiwan, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Resistant Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dose-response (DR) Relationship of XXB750 With Respect to Change From Baseline in Systolic Blood Pressure (SBP) 24 Hours Primary · Baseline, Week 12

To evaluate the efficacy and dose-response relationship of different doses of XXB750 compared to placebo in reducing the mean 24 hours ambulatory systolic blood pressure from baseline at Week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device. The primary outcome measure was evaluated using an optimally weighted contrast test following the Multiple Comparison Procedure-Modeling (MCP-MOD) methodology. There were five candidate models to capture the shape of the dose-response relationship for XXB750 at Week

GroupValue95% CI
Placebo-5.77-10.74 – -1.12
XXB750 30 mg-6.41-10.15 – -2.85
XXB750 60 mg-6.63-10.40 – -3.53
XXB750 120 mg-6.66-12.57 – -3.16
XXB750 120 mg/240 mg-5.40-9.58 – -0.36
Change From Baseline in SBP 24 Hours at Week 12 (Difference Between Highest XXB750 Dose and Placebo) Secondary · Baseline, Week 12

To evaluate the treatment effect of the highest XXB750 dose versus placebo in reducing the mean 24 hours SBP from baseline to Week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device.

GroupValue95% CI
Placebo-6.01± 2.42
XXB750 120 mg/240 mg-4.64± 2.49
Change From Baseline in SBP 24 Hours of Average of Week 9 and Week 12 (Difference Between Highest XXB750 Dose and Placebo) Secondary · Baseline, Week 9 and Week 12

To evaluate the treatment effect of the highest XXB750 dose versus placebo in the dosing interval average of ambulatory SBP as assessed by average of mean 24 hours SBP measured at week 9 and week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device.

GroupValue95% CI
Placebo-5.77± 2.13
XXB750 120 mg/240 mg-4.62± 2.21
The Model-based Estimated Percentage of Participants Achieving Blood Pressure (BP) Control Secondary · Week 12

To evaluate the percentage of participants achieving ambulatory BP control defined as mean 24 hours SBP \<130 mmHg and mean 24 hours DBP \< 80 mmHg with respect to the dose-response relationship of the four XXB750 dose level groups compared to placebo at week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device. Percentage of participants is derived from dose response analysis, using generalized MCP-Mod methodology for binary data.

GroupValue95% CI
Placebo13.2
XXB750 30 mg15.0
XXB750 60 mg17.7
XXB750 120 mg22.0
XXB750 120 mg/240 mg25.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 20 weeks.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 1/42 (2%)
Deaths: 0/42
XXB750 30 mg
Serious: 2/32 (6%)
Deaths: 0/32
XXB750 60 mg
Serious: 3/36 (8%)
Deaths: 0/36
XXB750 120 mg
Serious: 1/37 (3%)
Deaths: 0/37
XXB750 120 mg/240 mg
Serious: 3/42 (7%)
Deaths: 0/42

Serious adverse events (13 terms)

ReactionSystemPlaceboXXB750 30 mgXXB750 60 mgXXB750 120 mgXXB750 120 mg/240 mg
PneumoniaInfections and infestations
Cardiac failureCardiac disorders
Coronary artery diseaseCardiac disorders
Device related infectionInfections and infestations
Infectious pleural effusionInfections and infestations
Osteomyelitis acuteInfections and infestations
DehydrationMetabolism and nutrition disorders
HypokalaemiaMetabolism and nutrition disorders
Exertional rhabdomyolysisMusculoskeletal and connective tissue disorders
Plasma cell myelomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
DizzinessNervous system disorders
SyncopeNervous system disorders
Acute kidney injuryRenal and urinary disorders
Other adverse events (140 terms — click to expand)

ReactionSystemPlaceboXXB750 30 mgXXB750 60 mgXXB750 120 mgXXB750 120 mg/240 mg
COVID-19Infections and infestations
Urinary tract infectionInfections and infestations
DiarrhoeaGastrointestinal disorders
Oedema peripheralGeneral disorders
Blood creatine phosphokinase increasedInvestigations
HypokalaemiaMetabolism and nutrition disorders
DizzinessNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
Atrial fibrillationCardiac disorders
NasopharyngitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
Blood creatinine increasedInvestigations
Prothrombin time prolongedInvestigations
HyperkalaemiaMetabolism and nutrition disorders
HyperlipidaemiaMetabolism and nutrition disorders
HyperuricaemiaMetabolism and nutrition disorders
Pain in extremityMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
ProteinuriaRenal and urinary disorders
AnaemiaBlood and lymphatic system disorders
Iron deficiency anaemiaBlood and lymphatic system disorders
Angina pectorisCardiac disorders
BradycardiaCardiac disorders
Cardiac failureCardiac disorders
Diastolic dysfunctionCardiac disorders
Left ventricular hypertrophyCardiac disorders
Myocardial ischaemiaCardiac disorders
PalpitationsCardiac disorders
Sinus bradycardiaCardiac disorders
Supraventricular extrasystolesCardiac disorders
VertigoEar and labyrinth disorders
Eyelid oedemaEye disorders
Abdominal discomfortGastrointestinal disorders
Abdominal painGastrointestinal disorders
ToothacheGastrointestinal disorders
AstheniaGeneral disorders
FatigueGeneral disorders
Influenza like illnessGeneral disorders
Injection site painGeneral disorders
Injection site pruritusGeneral disorders

Most-reported serious reactions: Pneumonia, Cardiac failure, Coronary artery disease, Device related infection, Infectious pleural effusion, Osteomyelitis acute, Dehydration, Hypokalaemia.

Data from ClinicalTrials.gov NCT05562934 adverse events section.

Sponsor's own description

The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC) injections, compared to placebo. Since all study participants will be patients with rHTN, all study treatments will be given on top of maximally tolerated background antihypertensive therapy recommended by international guidelines for treatment of HTN (i.e., a thiazide or a thiazide-like diuretic, an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), and a long-acting dihydropyridine calcium channel blocker (CCB).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Natriuretic Peptide Receptor-1 Agonist for Resistant Hypertension: A Randomized Phase 2 Trial.
    White WB, Azizi M, Ferdinand K, Cohen DL, et al · · 2026 · cited 1× · PMID 41563174 · DOI 10.1016/j.jacc.2025.11.045

Verify or expand the search:

Other recruiting trials for Resistant Hypertension

Currently open trials in the same condition.

Other Novartis Pharmaceuticals trials

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05562934.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing