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
Qualifiers
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
Treatments tested in this trial
- IBI362
- Placebo
Treatment groups
336 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov