Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.
About this trial
A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in participants with mild to moderate hypertension complicated by overweight/obesity who have not received antihypertensive drug treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years old at the time of signing the informed consent form.
Confirmed diagnosis of hypertension.
No prior history of antihypertensive medication treatment at screening; or previously received only one type of antihypertensive medication during the same period and has discontinued all antihypertensive medications for at least 2 weeks prior to screening.
Voluntarily sign the informed consent form and be willing to strictly comply with the requirements and restrictions stated in the informed consent form and the protocol throughout the study, including but not limited to: maintaining a stable diet and exercise routine, receiving the study drug injections as scheduled, and keeping a study diary.
Disqualifiers
The investigator suspects that the participant may be allergic to the components of the study drug or drugs of the same class.
History of orthostatic hypotension, or blood pressure measured at screening meeting the criteria for orthostatic hypotension.
History or diagnostic evidence of secondary hypertension other than obstructive sleep apnea, including but not limited to: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
Concurrent use of beta-blockers within 1 month prior to screening.
Trial design
Design model
Parallel
Treatments tested in this trial
IBI362
DrugIBI362 will be administered subcutaneously once weekly (QW) in a step-up dose titration regimen over 48 weeks: * Weeks 1-4: 2 mg QW * Weeks 5-8: 4 mg QW * Weeks 9-24: 6 mg QW * Weeks 25-48: 6/9 mg QW.
Placebo
DrugMatching placebo will be administered subcutaneously once weekly (QW) for 48 weeks, with the same number of injections as the IBI362 group to maintain study blinding.
Treatment groups
336 Participants
are divided into 2 treatment groupsGroup A: IBI362 treatment GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment.
Change from baseline in msSBP at trough (end-of-dosing interval) at Week 16
Time frame
Week 16Secondary outcomes
1
To evaluate the effect of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared with placebo at Week 24 of treatment.
Change from baseline in Mean Sitting Systolic Arterial Pressure(msSBP) at Week 24.
Time frame
Week 242
To evaluate the effect of IBI362 on body weight compared with placebo at Weeks 16 and 24 of treatment.
Percent change from baseline in body weight at Weeks 16 and 24.
Time frame
Week 16 and Week 243
To evaluate the trough-to-peak ratio of the antihypertensive effect of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP)and Mean Sitting Diastolic Arterial Pressure（msDBP)at Week 16 of treatment.
Trough-to-peak ratio of the antihypertensive effect on Mean Sitting Systolic Arterial Pressure(msSBP)and Mean Sitting Diastolic Arterial Pressure（msDBP) calculated by ABPM at Week 16.
Time frame
Week 164
The effects of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared to placebo were evaluated at each node during treatment.
At Weeks 4, 8, 12, and 48, changes in msSBP from baseline.
Time frame
Week 4, 8, 12, and 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov