A Study to Evaluate Efficacy and Safety of GW906 Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by One or Two Antihypertensive Medications

September 17, 2026 updated by: Shenzhen Salubris Pharmaceuticals Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of GW906 Injection (SAL0132) Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by One or Two Antihypertensive Medications

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 as add-on therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy, safety, and pharmacokinetics of GW906 Injection used as add-on therapy in patients with hypertension not adequately controlled by one or two antihypertensive medications.

Participants are randomized to receive either GW906 Injection or placebo for 6 months.

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years, of either sex.
  • Treated hypertension on stable therapy with up to 1 or 2 antihypertensive medications. Stable therapy is defined as having no change in antihypertensive medication or dose within 4 weeks prior to randomization.
  • Mean sitting systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at the randomization visit.
  • Willing to participate in the study and provide written informed consent.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GW906

Subcutaneous injection. 24 weeks
Drug: GW906

Subcutaneous injection. 24 weeks
Placebo Comparator: Placebo

Subcutaneous injection. 24 weeks
Drug: Placebo

Subcutaneous injection. 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Change from baseline, calculated as the Week 24 value minus the baseline value, expressed in mmHg
Baseline, Weeks 4, 8, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 17, 2026

First Submitted That Met QC Criteria

September 17, 2026

First Posted (Actual)

September 23, 2026

Study Record Updates

Last Update Posted (Actual)

September 23, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAL0132A202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe