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New shot could tame stubborn high blood pressure

NCT ID NCT05562934

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called XXB750 in 189 people with resistant hypertension—high blood pressure that doesn't get better with standard treatments. Participants received either a placebo or one of several doses of XXB750 as a shot under the skin, on top of their usual medications. The goal was to see if XXB750 could safely lower blood pressure over 20 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XXB750 (a biologic drug given as a shot under the skin)
What this could lead to
If successful, XXB750 could offer a new treatment option for people with hard-to-control high blood pressure, potentially reducing their risk of heart attack and stroke.
What could go wrong
This is a mid-stage trial with only 189 participants, so results may not apply to everyone. The drug may not lower blood pressure enough or could have side effects. It is not a cure, and patients will still need other medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

189 people

The number who actually took part.

Started

Nov 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female participants who are ≥ 18 years old. 2. Signed informed consent prior to participation in the study. 3. 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. 4. 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. Exclusion Criteria: 1. Subjects with the following blood pressures at the specified time points are not eligible to participate in the study: 1. Office msSBP \<140 mmHg at Visit 20 OR 2. Office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at the end-of-run-in visit (Visit 30) OR 3. 24h mean SBP \>170 mmHg or 24h mean DBP \>105mmHg measured by ABPM at the end of the run-in (Visit 30). 2. 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). 3. Estimated GFR \<30 mL/min/1.73m2 using CKD-Epi equation at screening (Visit 1) or at end-of-run-in visit (Visit 30). 4. Serum potassium \>5.0 mmol/L (or equivalent plasma potassium value) at screening or end-of-run-in visit (Visit 30). 5. 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. 6. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥9%) 7. 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. 8. Chronic non-paroxysmal atrial fibrillation. 9. 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 10. History of a renal denervation procedure. 11. Mid-arm circumference ≥44 cm. The cuff should snugly fit on the arm with out the margins of cuff overhanging arm musculature. 12. 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 13. Receiving more than 4 antihypertensive medications. 14. Night shift workers. 15. History of presence of any other disease where the life expectancy is less than 3 years. 16. 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. 17. 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. 18. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. 19. History of drug abuse or alcohol dependency. 20. 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. 21. Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional registries is acceptable). 22. 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). 23. 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. 24. History of hypersensitivity to any of the study drugs, excipients or drugs of similar class.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder resistant hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Resistant hypertension

Contacts and locations

Locations

  • Alliance for Multispecialty Resrch

    Wichita, Kansas, 67207, United States

  • American Clinical Trials

    Acworth, Georgia, 30101, United States

  • Anderson Medical Research

    Ft. Washington, Maryland, 20744, United States

  • Canvas Clinical Research

    Lake Worth, Florida, 33467, United States

  • Capitol Cardiology Associates

    Lanham, Maryland, 20706, United States

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida, 33449, United States

  • Clinical Trials Research Sacramento

    Sacramento, California, 95821-2134, United States

  • Dominion Medical Associates

    Richmond, Virginia, 23219, United States

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • MD Medical Research

    Oxon Hill, Maryland, 20745, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • NexGen Research

    Lima, Ohio, 45801, United States

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Perth, Western Australia, 6000, Australia

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Vienna, 1190, Austria

  • Novartis Investigative Site

    Pleven, 5800, Bulgaria

  • Novartis Investigative Site

    Sofia, 1202, Bulgaria

  • Novartis Investigative Site

    Sofia, 1233, Bulgaria

  • Novartis Investigative Site

    Sofia, 1709, Bulgaria

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Baotou, Inner Mongolia, 014010, China

  • Novartis Investigative Site

    Beijing, 101200, China

  • Novartis Investigative Site

    Qingdao, 266000, China

  • Novartis Investigative Site

    Shanghai, 200025, China

  • Novartis Investigative Site

    Brandýs nad Labem, Czech Republic, 250 01, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Bobigny, 93009, France

  • Novartis Investigative Site

    Lille, 59000, France

  • Novartis Investigative Site

    Paris, 75015, France

  • Novartis Investigative Site

    Tours, 37044, France

  • Novartis Investigative Site

    Elsterwerda, Brandenburg, 04910, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60594, Germany

  • Novartis Investigative Site

    Berlin, 10787, Germany

  • Novartis Investigative Site

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    Ulm, 89077, Germany

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Pisa, PI, 56124, Italy

  • Novartis Investigative Site

    Chikushino-shi, Fukuka, 818-8516, Japan

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920 8650, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232 0024, Japan

  • Novartis Investigative Site

    Yokosuka, Kanagawa, 239-8567, Japan

  • Novartis Investigative Site

    Kishiwada, Osaka, 596-0042, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 103-0027, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-0031, Japan

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0027, Japan

  • Novartis Investigative Site

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Novartis Investigative Site

    Gdynia, 81-157, Poland

  • Novartis Investigative Site

    Katowice, 40-648, Poland

  • Novartis Investigative Site

    Krakow, 30-002, Poland

  • Novartis Investigative Site

    Wroclaw, 52-416, Poland

  • Novartis Investigative Site

    Bardejov, 085 01, Slovakia

  • Novartis Investigative Site

    Košice, 040 01, Slovakia

  • Novartis Investigative Site

    Nitra, 949 11, Slovakia

  • Novartis Investigative Site

    Svidník, 089 01, Slovakia

  • Novartis Investigative Site

    Seville, Andalusia, 41014, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • Novartis Investigative Site

    Terrassa, Catalonia, 08221, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Barcelona, 08025, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taipei, 110, Taiwan

  • Novartis Investigative Site

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    London, GBR, EC1M 6BQ, United Kingdom

  • Novartis Investigative Site

    London, W1T 7HA, United Kingdom

  • Novartis Investigative Site

    Salford, M6 8HD, United Kingdom

  • Orange County Research Center

    Tustin, California, 92780, United States

  • Parkway Medical Center

    Birmingham, Alabama, 35206, United States

  • Pinnacle Research Group Llc

    Anniston, Alabama, 36207, United States

  • Tennessee Center For Clinical Trials

    Tullahoma, Tennessee, 37388, United States

  • The Research Center of the Upstate

    Greenville, South Carolina, 29607, United States

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