HypertensionPhase 2NCT07833098
A Phase II Study of VB19055 in Uncontrolled or Resistant Hypertension
A Phase 2 study testing VB19055 Dose A QD, VB19055 Dose B QD and VB19055 Dose C QD in people with Hypertension and Resistant Hypertension, run by Zhejiang Yangli Pharmaceutical Technology Co., Ltd. at 24 sites in China.
Trial summary
A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial of VB19055 for 12 weeks in 240 adults with uncontrolled hypertension (including resistant hypertension). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Resistant Hypertension, Uncontrolled Hypertension
- What is being tested?
- VB19055 Dose A QD, VB19055 Dose B QD and VB19055 Dose C QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 24 sitesChina
- Study dates
- Sep 2026to Feb 2028
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female aged ≥18 years;
- Mean seated systolic blood pressure (SBP) ≥140 mmHg and <170 mmHg at screening, and SBP ≥135 mmHg and <170 mmHg at randomization (Mean seated SBP/DBP is defined as the average of 3 seated SBP/DBP measurements obtained by automated office blood pressure measurement at a single clinic visit. If the trial participant has not taken routine antihypertensive medication prior to the visit, a repeat mean blood pressure measurement may be performed within 2 days after dosing.)
- Meet at least one of the following two criteria:
- Uncontrolled hypertension: At screening and randomization, as judged by the investigator, stably taking antihypertensive medications of two different therapeutic classes at maximum tolerated dose for ≥4 weeks (at least one must be a non-potassium-sparing diuretic). Beta-blockers used for other indications (e.g., migraine, heart failure, coronary artery disease) shall not count toward antihypertensive medications for eligibility;
- Resistant hypertension: At screening and randomization, as judged by the investigator, stably taking antihypertensive medications of ≥3 different therapeutic classes at maximum tolerated dose for ≥4 weeks (at least one must be a non-potassium-sparing diuretic). Beta-blockers used for other indications (e.g., migraine, heart failure, coronary artery disease) shall not count toward antihypertensive medications for eligibility.
- Serum potassium (K⁺) ≥3.5 and <5.0 mmol/L at screening (local laboratory);
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- Morning (08:00 ± 2 hours) serum cortisol >3 µg/dL (local or central laboratory);
- Female participants of childbearing potential agree to no pregnancy plans and use highly effective contraception from ICF signing until 30 days after last dose; male participants agree to no fertility plans and use highly effective contraception from ICF signing until 90 days after last dose (see Appendix 2 for details);
- Voluntarily participate in this clinical study and have the capacity to sign the informed consent form.
Who cannot join
- Known causes of secondary hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism/hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation, or obstructive sleep apnea syndrome being treated with continuous positive airway pressure (CPAP) (participants with primary aldosteronism may be considered for enrollment unless adrenalectomy is planned before study completion);
- Have undergone coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or any major surgery (e.g., valve replacement, peripheral artery bypass surgery) within 6 months prior to ICF signing, or plan to undergo such procedures during the study;
- Arrhythmia requiring treatment or left bundle branch block at screening;
- Known chronic permanent atrial fibrillation;
- New York Heart Association (NYHA) Class III or IV chronic heart failure at screening;
- Glycated hemoglobin (HbA1c) >9.5% at screening;
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- Adrenal insufficiency diagnosed within 6 months prior to ICF signing;
- Any of the following abnormal laboratory/physical examination findings at screening:
- Serum sodium <135 mmol/L;
- Mean seated SBP ≥170 mmHg or mean seated DBP ≥110 mmHg;
- Aspartate aminotransferase (AST) >3.0 × upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3.0 × ULN;
- Total bilirubin >2.0 × ULN, unless the participant has a history of Gilbert's syndrome;
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²;
- Body mass index (BMI) <18 kg/m² or ≥45 kg/m²;
- Any of the following ECG abnormalities: heart rate <45 bpm or >110 bpm; QT interval corrected by Fridericia's formula (QTcF) >470 ms;
- Clinically significant abnormal chest imaging (chest X-ray or computed tomography [CT]) assessed by the investigator as posing a safety risk;
- Positive hepatitis B surface antigen (HBsAg) with possible viral replication (positive HBV DNA) as judged by the investigator based on further testing, or positive anti-hepatitis C virus (HCV) antibody, or positive human immunodeficiency virus (HIV) antibody.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou
Xin Zhang
Peking University People's Hospital
Beijing
Jing Liu
The Third Hospital of Changsha
Changsha
Weifen Liang
The Third Xiangya Hospital of Central South University
Changsha
Hong Yuan
Chengdu Second People's Hospital
Chengdu
Jianxiong Liu
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Fang Qing
Daqing People's Hospital
Daqing
Xianyou Ji
The First Hospital of Hebei Medical University
Hebei
Jun Liu
The First Affiliated Hospital of University of South China
Hengyang
Jie Wu
Affiliated Hospital of Jining Medical University
Jining
Yuchuan Dai
The Third People's Hospital of Luoyang
Luoyang
Lipeng Li
Zhongda Hospital, Southeast University
Nanjing
Qiming Dai
Panjin Liaohe Oilfield Gem Flower Hospital
Panjin
Liqun Liu
Qilu Hospital of Shandong University
Shandong
Peili Bu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Jiguang Wang
Shanxi Cardiovascular Hospital
Shaxi
Xuling Wang
Liaoning Provincial People's Hospital
Shenyang
Aijie Hou
Shengjing Hospital of China Medical University
Shenyang
Xiaodong Li
Suzhou Municipal Hospital of Anhui Province
Suzhou
Hailong Qiu
China Resources WISCO General Hospital
Wuhan
Nian Li
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Xiang Cheng
The First People's Hospital of Xinxiang
Xinxiang
Tao Yang
The Seventh People's Hospital of Zhengzhou City
Zhengzhou
Jing Li
Zhengzhou Central Hospital
Zhengzhou
Shuhua Yu
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase II Clinical Study to Evaluate the Efficacy and Safety of VB19055 in Participants With Hypertension (Including Resistant Hypertension) Whose Blood Pressure Remains Uncontrolled Despite Treatment With Two or More Antihypertensive Medications
A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial of VB19055 for 12 weeks in 240 adults with uncontrolled hypertension (including resistant hypertension).
Read the detailed description
This study is a multicenter, randomized, double-blind, placebo parallel-controlled, dose-ranging Phase II clinical trial designed to evaluate the efficacy and safety of 12-week treatment with VB19055 in trial participants with hypertension (including resistant hypertension) whose blood pressure remains uncontrolled despite treatment with two or more antihypertensive medications, and to explore the dosing regimen for confirmatory studies.
- Being tested
- VB19055 Dose A QD, VB19055 Dose B QD, VB19055 Dose C QD, VB19055 placebo QD
- Keywords
- Hypertension, Resistant Hypertension, Uncontrolled Hypertension, Aldosterone Synthase Inhibitor
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB19055 Dose A QDDrug
VB19055 Dose A orally once daily (QD) for 12 weeks
VB19055 Dose B QDDrug
VB19055 DoseB orally once daily (QD) for 12 weeks
VB19055 Dose C QDDrug
VB19055 Dose C orally once daily (QD) for 12 weeks
VB19055 placebo QDDrug
VB19055 placebo orally once daily (QD) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| VB19055 Arm A | Experimental | Not described Receives: Drug: VB19055 Dose A QD |
| VB19055 Arm B | Experimental | Not described Receives: Drug: VB19055 Dose B QD |
| VB19055 Arm C | Experimental | Not described Receives: Drug: VB19055 Dose C QD |
| VB19055 placebo QD | Placebo comparator | Not described Receives: Drug: VB19055 placebo QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in seated clinic systolic blood pressure at Week 12.
Measured: at the end of the 12-week treatment period
Secondary outcomes (5)
Change from baseline in seated clinic diastolic blood pressure at Week 12
Measured: at the end of the 12-week treatment period
Percentage of participants with a seated blood pressure of less than 140/90 mmHg at the end of the 12-week treatment period
Measured: at the end of the 12-week treatment period
Percentage of participants with a seated blood pressure of less than 130/80 mmHg at the end of the 12-week treatment period
Measured: at the end of the 12-week treatment period
Change from baseline in mean SBP and DBP, daytime SBP and DBP, nighttime SBP and DBP, and trough-to-peak ratio (T/P) of SBP and DBP by ambulatory blood pressure monitoring (ABPM) at Week 12
Measured: at the end of the 12-week treatment period
Adverse events, including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), TEAEs leading to permanent discontinuation, adverse events of special interest (AESI), etc.
Measured: 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiguang Wang, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833098
- Sponsor's protocol ID
- VB19055-201
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No