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

NCT07835984 | Not Yet Recruiting Phase 2

• 1 other identifier: SAL0132A202
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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 as add-on therapy.

Conditions

Hypertension

Keywords

Hypertension; siRNA; GW906; SAL0132; Add-on Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Baseline, Weeks 4, 8, and 24

Study Arms (2)

GW906

ACTIVE COMPARATOR

Subcutaneous injection. 24 weeks

Drug: GW906

Placebo

PLACEBO COMPARATOR

Subcutaneous injection. 24 weeks

Drug: Placebo

Interventions

GW906 DRUG

Subcutaneous injection. 24 weeks

GW906

Placebo DRUG

Subcutaneous injection. 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jianan Wang, Professor

CONTACT

86-1599008651; jiguangwang@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (1)