A Study to Evaluate Efficacy and Safety of GW906 in Patients With Essential Hypertension
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
1 other identifier
interventional
319
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hypertension
Started Dec 2025
Shorter than P25 for phase_2 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2026
CompletedFirst Submitted
Initial submission to the registry
September 17, 2026
CompletedFirst Posted
Study publicly available on registry
September 23, 2026
CompletedSeptember 23, 2026
September 1, 2026
9 months
September 17, 2026
September 17, 2026
Conditions
Keywords
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
EXPERIMENTALSubcutaneous injection
Placebo
PLACEBO COMPARATORSubcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
December 24, 2025
Primary Completion
September 15, 2026
Study Completion
September 15, 2026
Last Updated
September 23, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share