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A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients

ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent.

Males or females aged 18 to 75 years.

Diagnosis of primary hypertension without anti-HTN medication or with one anti-HTN medication

Mean sitting SBP ≥140 mmHg and < 170 mmHg measured by OBPM.

Disqualifiers

Known history of secondary hypertension.

Orthostatic hypotension.

Laboratory parameter assessments outside of range at screening：

Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2× Upper Limit of Normal (ULN)

Trial design

Design model

Parallel

Treatments tested in this trial

  • IBI3016

    Drug

    Solution of Injection

  • Placebo

    Other intervention

    0.9% sodium chloride saline solution

Treatment groups

352 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: IBI3016 dose 4Experimental treatment 1 intervention
Group B: IBI3016 dose 1Experimental treatment 1 intervention
Group C: IBI3016 dose 2Experimental treatment 1 intervention
Group D: placeboPlacebo comparator 1 intervention
Group E: IBI3016 dose 3Experimental treatment 1 intervention
Group F: IBI3016 dose 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in SBP by OBPM

Change from baseline at Month 3 in systolic blood pressure (SBP) by office blood pressure measurement (OBPM)

Time frame
From baseline through month 3

Secondary outcomes

1

Change in Mean 24hr SBP by ABPM

Change from baseline at Month 3 in mean 24hr SBP by ambulatory blood pressure measurement (ABPM)

Time frame
From baseline through month 3
2

Change in SBP and DBP by OBPM

Change from baseline through month 6 in SBP and diastolic blood pressure (DBP) by OBPM

Time frame
From baseline through month 6
3

Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM

From baseline through month 6

Time frame
Change from baseline through month 6 in Mean 24hr, mean daytime, mean nighttime SBP and DBP by OBPM
4

Percentage Change in AGT by blood test

Percentage Change from baseline through month 24 in Angiotensinogen (AGT) by blood test

Time frame
From baseline through month 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: