HypertensionPhase 2NCT07835971
A Study to Evaluate Efficacy and Safety of GW906 in Patients With Essential Hypertension
A Phase 2 study testing GW906 in people with Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of GW906 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of GW906. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- GW906
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2025to 15 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 75 years, of either sex.
- Mean sitting systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at screening.
- Willing to participate in the study and provide written informed consent.
Who cannot join
- Secondary hypertension.
- orthostatic hypotension.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5× upper limit of normal (ULN); Total bilirubin > 1.5 × ULN; International normalized ratio (INR) > 2.0; Serum potassium > 5.0 mmol/L or < 3.5 mmol/L; eGFR≤30 mL/min/1.73m^2.
- Received an investigational agent within the last 3 months.
- Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus.
- History of any cardiovascular event within 12 months.
- History of intolerance to SC injection(s).
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GW906 (SAL0132) Injection in Patients With Essential Hypertension
The purpose of this study is to evaluate the effect of GW906 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of GW906.
Read the detailed description
This study consists of two parts, Part A and Part B. Part A is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy, safety, and pharmacokinetics of GW906 Injection in patients with essential hypertension.
Part B is a multicenter, open-label, long-term study designed to evaluate the long-term safety and efficacy of GW906 Injection in patients with essential hypertension.
In Part A, participants are randomized to receive either GW906 Injection or placebo for 6 months. Participants who complete Part A are eligible to enter Part B and will receive GW906 Injection.
- Conditions
- Hypertension
- Being tested
- GW906, Placebo
- Keywords
- Hypertension, siRNA, GW906, SAL0132
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW906Drug
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| GW906 | Experimental | Subcutaneous injection Receives: Drug: GW906 |
| Placebo | Placebo comparator | Subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12
msSBP will be measured in the office using a validated sphygmomanometer, with the participant seated and resting quietly for at least 5 minutes. The primary endpoint is the change from baseline, calculated as the Week 12 value minus the baseline value, expressed in mmHg
Measured: Baseline and Month 3
Secondary outcomes (1)
Change from baseline in mean sitting systolic blood pressure (msSBP) at Weeks 4, 8, and 24 of the double-blind period
Change from baseline, calculated as the Week 24 value minus the baseline value, expressed in mmHg
Measured: Baseline, Weeks 4, 8, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start24 Dec 2025
- Primary completion15 Sep 2026
- Study completion15 Sep 2026 (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.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835971
- Sponsor's protocol ID
- SAL0132A201
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GW906 (SAL0132) Injection in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT07835971
- Acronym / sponsor ID
- SAL0132A201
- Conditions
- Hypertension
- Keywords
- Hypertension, siRNA, GW906, SAL0132
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
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 study is to evaluate the effect of GW906 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of GW906.
Detailed description
This study consists of two parts, Part A and Part B. Part A is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy, safety, and pharmacokinetics of GW906 Injection in patients with essential hypertension.
Part B is a multicenter, open-label, long-term study designed to evaluate the long-term safety and efficacy of GW906 Injection in patients with essential hypertension.
In Part A, participants are randomized to receive either GW906 Injection or placebo for 6 months. Participants who complete Part A are eligible to enter Part B and will receive GW906 Injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GW906 | Experimental | Drug: GW906Subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 75 years, of either sex.
- Mean sitting systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at screening.
- Willing to participate in the study and provide written informed consent.
Key exclusion criteria (7 listed)
- Secondary hypertension.
- orthostatic hypotension.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5× upper limit of normal (ULN); Total bilirubin > 1.5 × ULN; International normalized ratio (INR) > 2.0; Serum potassium > 5.0 mmol/L or < 3.5 mmol/L; eGFR≤30 mL/min/1.73m^2.
- Received an investigational agent within the last 3 months.
- Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus.
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 |
|---|---|---|
| GW906Subcutaneous injection | Drug | GW906 |
| PlaceboSubcutaneous injection | Drug | Placebo |
Primary outcome
Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12
Time frame: Baseline and Month 3
msSBP will be measured in the office using a validated sphygmomanometer, with the participant seated and resting quietly for at least 5 minutes. The primary endpoint is the change from baseline, calculated as the Week 12 value minus the baseline value, expressed in mmHg
1 secondary outcome
Change from baseline in mean sitting systolic blood pressure (msSBP) at Weeks 4, 8, and 24 of the double-blind period
Time frame: Baseline, Weeks 4, 8, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW906 in people with Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12 (time frame: Baseline and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.