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

ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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/1.73m².

Received an investigational agent within the last 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GW906

    Drug

    Subcutaneous injection. 24 weeks

  • Placebo

    Drug

    Subcutaneous injection. 24 weeks

Treatment groups

560 Participants
are divided into 2 treatment groups
Group A: GW906Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
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

Time frame
Baseline, Weeks 4, 8, and 24

Other outcomes

Sponsors and contacts

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