Resistant HypertensionPhase 2NCT05562934
An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.
A Phase 2 study testing XXB750 drug in people with Resistant Hypertension, run by Novartis Pharmaceuticals at 78 sites in 16 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- XXB750 drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 78 sitesin 16 countries
- Study dates
- 8 Nov 2022to 27 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants who are ≥ 18 years old.
- Signed informed consent prior to participation in the study.
- Apparent rHTN at screening (Visit 1) defined as uncontrolled BP with an office msSBP ≥ 140 mmHg despite treatment with stable (i.e., unchanged for ≥4 weeks), optimal or maximally tolerated doses of three or four antihypertensive drugs of different classes, including an ACEI/ARB, a long-acting dihydropyridine CCB, and a thiazide or thiazide-like diuretic. Participant with documented intolerance to any doses of CCBs may be eligible if receiving another class of antihypertensive medication at an optimal or maximally tolerated dose (referred to as triple background antihypertensive therapy. An optimal dose is defined as the highest dose taking in to account participant's documented comorbidities and tolerability per investigator's clinical judgment.
- Mean 24hr SBP ≥135 mmHg (measured by ABPM) at the end-of Run-in-Visit (Visit 30) on treatment with optimal or maximally tolerated doses of an ACEI/ARB, a long-acting dihydropyridine CCB (or a suitable alternative in case of intolerance per inclusion criterion above), and a thiazide or thiazide-like diuretic.
Who cannot join
- Subjects with the following blood pressures at the specified time points are not eligible to participate in the study:
- Office msSBP <140 mmHg at Visit 20 OR
- Office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at the end-of-run-in visit (Visit 30) OR
- 24h mean SBP >170 mmHg or 24h mean DBP >105mmHg measured by ABPM at the end of the run-in (Visit 30).
- Known history of secondary hypertension (moderate-to-severe obstructive sleep apnea without receiving CPAP therapy (either face mask or nasal device), renovascular hypertension, primary aldosteronism, pheochromocytoma, Cushing syndrome, aortic coarctation or other cause of secondary hypertension).
- Estimated GFR <30 mL/min/1.73m2 using CKD-Epi equation at screening (Visit 1) or at end-of-run-in visit (Visit 30).
Show all 35Show fewer
- Serum potassium >5.0 mmol/L (or equivalent plasma potassium value) at screening or end-of-run-in visit (Visit 30).
- Current therapy with a mineralocorticoid receptor antagonist (MRA) or sacubitril/valsartan or received an MRA or sacubitril/valsartan within the 4 weeks prior to screening.
- Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥9%)
- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), high-grade AV block (e.g., Mobitz type II and third-degree AV block in absence of a pacemaker) within 6 months of screening according to investigator's judgement.
- Chronic non-paroxysmal atrial fibrillation.
- Acute myocardial infarction (AMI) or unstable angina, or any history of ischemic or hemorrhagic stroke within 12 months of screening; or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 12 months of screening
- History of a renal denervation procedure.
- Mid-arm circumference ≥44 cm. The cuff should snugly fit on the arm with out the margins of cuff overhanging arm musculature.
- Patients with history of hospitalisation for hypertensive emergencies characterised by severe hypertension (usually grade 3) associated with funduscopic changes (flame haemorrhages and/or papilloedema), microangiopathy, disseminated intravascular coagulation, encephalopathy, acute aortic dissection, acute myocardial ischaemia, or acute heart failure any time prior to screening or hospitalisation for non-emergent/non-urgent uncontrolled hypertension without target organ damage within 3 months prior to screening
- Receiving more than 4 antihypertensive medications.
- Night shift workers.
- History of presence of any other disease where the life expectancy is less than 3 years.
- History of malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin or localized prostate cancer), treated or untreated, within the past 3 years, regardless of whether there is evidence of local recurrence or metastases.
- Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x the upper limit of normal (ULN), or bilirubin >1.5 mg/dl at Visit 1.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- History of drug abuse or alcohol dependency.
- Lacking the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, a participant that would be unlikely or unable to comply with study protocol.
- Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional registries is acceptable).
- Requiring prolonged/regular use of NSAIDs except for prophylactic use of low dose aspirin up to 325 mg QD or other prohibited medications during of the study (i.e., required use for longer than 1 week).
- Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required within a maximum of 7 days prior to enrollment of all women of childbearing potential). Documentation of highly effective contraception is also required for women of childbearing potential (see below).
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 months after stopping medication. Highly effective contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant.
- Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.
- In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women are considered not of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential.
- If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.
- History of hypersensitivity to any of the study drugs, excipients or drugs of similar class.
Trial locations and contacts
78 sites in 16 countries.
78 sites in 16 countries
United States18 sites
American Clinical Trials
Acworth, Georgia, 30101
Pinnacle Research Group Llc
Anniston, Alabama, 36207
Parkway Medical Center
Birmingham, Alabama, 35206
Anderson Medical Research
Ft. Washington, Maryland, 20744
The Research Center of the Upstate
Greenville, South Carolina, 29607
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Canvas Clinical Research
Lake Worth, Florida, 33467
Capitol Cardiology Associates
Lanham, Maryland, 20706
NexGen Research
Lima, Ohio, 45801
Manassas Clinical Research Center
Manassas, Virginia, 20110
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
MD Medical Research
Oxon Hill, Maryland, 20745
Dominion Medical Associates
Richmond, Virginia, 23219
Clinical Trials Research Sacramento
Sacramento, California, 95821-2134
Tennessee Center For Clinical Trials
Tullahoma, Tennessee, 37388
Orange County Research Center
Tustin, California, 92780
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
Alliance for Multispecialty Resrch
Wichita, Kansas, 67207
Japan8 sites
Novartis Investigative Site
Chikushino-shi, Fukuka, 818-8516
Novartis Investigative Site
Chuo Ku, Tokyo, 103-0027
Novartis Investigative Site
Chuo Ku, Tokyo, 104-0031
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0027
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920 8650
Novartis Investigative Site
Kishiwada, Osaka, 596-0042
Novartis Investigative Site
Yokohama, Kanagawa, 232 0024
Novartis Investigative Site
Yokosuka, Kanagawa, 239-8567
Spain7 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Seville, Andalusia, 41014
Novartis Investigative Site
Terrassa, Catalonia, 08221
Novartis Investigative Site
Valencia, 46010
China5 sites
Novartis Investigative Site
Baotou, Inner Mongolia, 014010
Novartis Investigative Site
Beijing, 101200
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Novartis Investigative Site
Qingdao, 266000
Novartis Investigative Site
Shanghai, 200025
Germany5 sites
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Elsterwerda, Brandenburg, 04910
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt am Main, Hesse, 60594
Novartis Investigative Site
Ulm, 89077
Italy5 sites
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Pisa, PI, 56124
Bulgaria4 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Sofia, 1202
Novartis Investigative Site
Sofia, 1233
Novartis Investigative Site
Sofia, 1709
France4 sites
Novartis Investigative Site
Bobigny, 93009
Novartis Investigative Site
Lille, 59000
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Tours, 37044
Poland4 sites
Novartis Investigative Site
Gdynia, 81-157
Novartis Investigative Site
Katowice, 40-648
Novartis Investigative Site
Krakow, 30-002
Novartis Investigative Site
Wroclaw, 52-416
Slovakia4 sites
Novartis Investigative Site
Bardejov, 085 01
Novartis Investigative Site
Košice, 040 01
Novartis Investigative Site
Nitra, 949 11
Novartis Investigative Site
Svidník, 089 01
Taiwan4 sites
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 110
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taoyuan, 33305
United Kingdom3 sites
Novartis Investigative Site
London, GBR, EC1M 6BQ
Novartis Investigative Site
London, W1T 7HA
Novartis Investigative Site
Salford, M6 8HD
Australia2 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Perth, Western Australia, 6000
Austria2 sites
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Vienna, 1190
Czechia2 sites
Novartis Investigative Site
Brandýs nad Labem, Czech Republic, 250 01
Novartis Investigative Site
Prague, 128 08
Netherlands1 site
Novartis Investigative Site
Amsterdam, North Holland, 1105 AZ
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, 20-week Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of XXB750 in Patients With Resistant Hypertension
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).
Read the detailed description
Subjects will enter run-in period which lasts for approximately 2 weeks. The study duration is for 20 weeks during which each participant will receive a total of 3 doses of study medication (in addition to 1 dose of study medication during run-in). Participants will be followed to monitor their safety for an additional 8 weeks during which time no active study medication will be given.
- Conditions
- Resistant Hypertension
- Being tested
- XXB750 drug, Placebo
- Keywords
- hypertension, resistant hypertension, rHTN, not controlled hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XXB750 drugBiological
SC injection
PlaceboOther
SC injection
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Lowest dose Receives: Biological: XXB750 drug |
| Dose 2 | Experimental | Dose 2 Receives: Biological: XXB750 drug |
| Dose 3 | Experimental | Dose 3 Receives: Biological: XXB750 drug |
| Dose 4 | Experimental | Highest dose Receives: Biological: XXB750 drug |
| Dose 5 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-response (DR) Relationship of XXB750 With Respect to Change From Baseline in Systolic Blood Pressure (SBP) 24 Hours
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 12 endpoint. The outcome for the single best candidate model is shown in the Statistical Analysis section.
Measured: Baseline, Week 12
Secondary outcomes (3)
Change From Baseline in SBP 24 Hours at Week 12 (Difference Between Highest XXB750 Dose and Placebo)
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.
Measured: Baseline, Week 12
Change From Baseline in SBP 24 Hours of Average of Week 9 and Week 12 (Difference Between Highest XXB750 Dose and Placebo)
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.
Measured: Baseline, Week 9 and Week 12
The Model-based Estimated Percentage of Participants Achieving Blood Pressure (BP) Control
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start8 Nov 2022
- Primary completion2 Jul 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The planned duration of treatment is 12 weeks per participant. Participants may be discontinued from treatment earlier due to unacceptable adverse events, disease progression and/or if treatment is discontinued at the discretion of the investigator or the participant. Following the conclusion of the 12-week Randomized Treatment Period, participants will enter an 8-week Safety Follow-up Period in which participants may be treated at the discretion of the investigator taking into account that their blood pressure may still be affected by the study treatment for some time after its discontinuation, especially those who were randomized to XXB750.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562934
- Sponsor's protocol ID
- CXXB750B12201
- Other IDs
- 2021-005738-41
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2022
- Last updated
- 12 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
White WB, Azizi M, Ferdinand K, Cohen DL, Nuhrenberg T, Lefkowitz M, Jiao R, Rizkala AR, Maboudian M, Williams B. Natriuretic Peptide Receptor-1 Agonist for Resistant Hypertension: A Randomized Phase 2 Trial. J Am Coll Cardiol. 2026 May 12;87(18):2373-2387. doi: 10.1016/j.jacc.2025.11.045. Epub 2026 Jan 21.
PubMed 41563174
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group, 20-week Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of XXB750 in Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT05562934
- Acronym / sponsor ID
- CXXB750B12201
- Conditions
- Resistant Hypertension
- Keywords
- hypertension, resistant hypertension, rHTN, not controlled hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Subjects will enter run-in period which lasts for approximately 2 weeks. The study duration is for 20 weeks during which each participant will receive a total of 3 doses of study medication (in addition to 1 dose of study medication during run-in). Participants will be followed to monitor their safety for an additional 8 weeks during which time no active study medication will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- The planned duration of treatment is 12 weeks per participant. Participants may be discontinued from treatment earlier due to unacceptable adverse events, disease progression and/or if treatment is discontinued at the discretion of the investigator or the participant. Following the conclusion of the 12-week Randomized Treatment Period, participants will enter an 8-week Safety Follow-up Period in which participants may be treated at the discretion of the investigator taking into account that their blood pressure may still be affected by the study treatment for some time after its discontinuation, especially those who were randomized to XXB750.
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Biological: XXB750 drugLowest dose |
| Dose 2 | Experimental | Biological: XXB750 drugDose 2 |
| Dose 3 | Experimental | Biological: XXB750 drugDose 3 |
| Dose 4 | Experimental | Biological: XXB750 drugHighest dose |
| Dose 5 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants who are ≥ 18 years old.
- Signed informed consent prior to participation in the study.
- Apparent rHTN at screening (Visit 1) defined as uncontrolled BP with an office msSBP ≥ 140 mmHg despite treatment with stable (i.e., unchanged for ≥4 weeks), optimal or maximally tolerated doses of three or four antihypertensive drugs of different classes, including an ACEI/ARB, a long-acting dihydropyridine CCB, and a thiazide or thiazide-like diuretic. Participant with documented intolerance to any doses of CCBs may be eligible if receiving another class of antihypertensive medication at an optimal or maximally tolerated dose (referred to as triple background antihypertensive therapy. An optimal dose is defined as the highest dose taking in to account participant's documented comorbidities and tolerability per investigator's clinical judgment.
- Mean 24hr SBP ≥135 mmHg (measured by ABPM) at the end-of Run-in-Visit (Visit 30) on treatment with optimal or maximally tolerated doses of an ACEI/ARB, a long-acting dihydropyridine CCB (or a suitable alternative in case of intolerance per inclusion criterion above), and a thiazide or thiazide-like diuretic.
Key exclusion criteria (35 listed)
- Subjects with the following blood pressures at the specified time points are not eligible to participate in the study:
- Known history of secondary hypertension (moderate-to-severe obstructive sleep apnea without receiving CPAP therapy (either face mask or nasal device), renovascular hypertension, primary aldosteronism, pheochromocytoma, Cushing syndrome, aortic coarctation or other cause of secondary hypertension).
- Estimated GFR <30 mL/min/1.73m2 using CKD-Epi equation at screening (Visit 1) or at end-of-run-in visit (Visit 30).
- Serum potassium >5.0 mmol/L (or equivalent plasma potassium value) at screening or end-of-run-in visit (Visit 30).
- Current therapy with a mineralocorticoid receptor antagonist (MRA) or sacubitril/valsartan or received an MRA or sacubitril/valsartan within the 4 weeks prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XXB750 drugSC injection | Biological | Dose 1, Dose 2, Dose 3, Dose 4 |
| PlaceboSC injection | Other | Dose 5 |
Primary outcome
Dose-response (DR) Relationship of XXB750 With Respect to Change From Baseline in Systolic Blood Pressure (SBP) 24 Hours
Time frame: 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 12 endpoint. The outcome for the single best candidate model is shown in the Statistical Analysis section.
3 secondary outcomes
Change From Baseline in SBP 24 Hours at Week 12 (Difference Between Highest XXB750 Dose and Placebo)
Time frame: Baseline, Week 12
Change From Baseline in SBP 24 Hours of Average of Week 9 and Week 12 (Difference Between Highest XXB750 Dose and Placebo)
Time frame: Baseline, Week 9 and Week 12
The Model-based Estimated Percentage of Participants Achieving Blood Pressure (BP) Control
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41563174White WB, Azizi M, Ferdinand K, Cohen DL, Nuhrenberg T, Lefkowitz M, Jiao R, Rizkala AR, Maboudian M, Williams B. Natriuretic Peptide Receptor-1 Agonist for Resistant Hypertension: A Randomized Phase 2 Trial. J Am Coll Cardiol. 2026 May 12;87(18):2373-2387. doi: 10.1016/j.jacc.2025.11.045. Epub 2026 Jan 21.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
78 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XXB750 drug in people with Resistant Hypertension, run by Novartis Pharmaceuticals at 78 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, Japan, Spain, China, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-response (DR) Relationship of XXB750 With Respect to Change From Baseline in Systolic Blood Pressure (SBP) 24 Hours (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.