Overview

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

Inclusion Criteria:

1. Aged ≥ 18 years old at the time of signing the informed consent form.
2. Confirmed diagnosis of hypertension.
3. 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.
4. 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.

Exclusion Criteria:

1. The investigator suspects that the participant may be allergic to the components of the study drug or drugs of the same class.
2. History of orthostatic hypotension, or blood pressure measured at screening meeting the criteria for orthostatic hypotension.
3. 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.
4. Concurrent use of beta-blockers within 1 month prior to screening.
5. Self-reported body weight change \> 5 kg within 3 months.
6. History of acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), large artery aneurysm or dissecting aneurysm, transient ischemic attack (TIA), cerebrovascular accident, severe arrhythmia (e.g., ventricular fibrillation, ventricular flutter, atrial fibrillation, atrial flutter, second-degree or higher atrioventricular block, sick sinus syndrome, etc.) within 6 months; or history of decompensated heart failure or heart failure of New York Heart Association (NYHA) Class III or IV; or history of severe diseases such as epilepsy or syncope, which the investigator deems unsuitable for trial participation.
7. Confirmed diagnosis of diabetes mellitus, or laboratory tests showing glycated hemoglobin (HbA1c) ≥ 6.5%, fasting blood glucose ≥ 7 mmol/L and/or random blood glucose ≥ 11.1 mmol/L.
8. History of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, acute cholangitis, or symptomatic/treated gallbladder disease (except for participants who have undergone cholecystectomy and are judged eligible by the investigator); or serum amylase or lipase \> 2.0 × Upper Limit of Normal (ULN); or fasting serum triglycerides ≥ 5.64 mmol/L (500 mg/dl).
9. Chronic gastrointestinal diseases or systemic diseases that may affect gastrointestinal motility at screening, or use of drugs that may alter gastrointestinal motility, appetite or absorption within 3 months prior to screening.
10. History or relevant family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.