Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity

Official title

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

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

Interventions

• Drug IBI362
  IBI362 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.
• Drug Placebo
  Matching 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.

Primary outcome measures

• To evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment. [Time frame: Week 16]

Secondary outcome measures (12)

• To evaluate the effect of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared with placebo at Week 24 of treatment. [Time frame: Week 24]
• To evaluate the effect of IBI362 on body weight compared with placebo at Weeks 16 and 24 of treatment. [Time frame: Week 16 and Week 24]
• 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. [Time frame: Week 16]
• The effects of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared to placebo were evaluated at each node during treatment. [Time frame: Week 4, 8, 12, and 48]
• The effects of IBI362 on mean sitting diastolic arterial pressure (msDBP) compared to placebo were evaluated at each node during treatment. [Time frame: Week 4, 8, 12, 16, 24, and 48]
• The effects of IBI362 on mean arterial pressure (MAP) compared to placebo were evaluated at each node during treatment. [Time frame: Week 4, 8, 12, 16, 24, and 48]
• The effect of IBI362 on blood pressure reduction efficacy and compliance compared to placebo was evaluated at each node during treatment. [Time frame: Week 4, 8, 12, 16, 24, 48]
• The effect of IBI362 on blood pressure reduction efficacy and compliance compared to placebo was evaluated at each node during treatment. [Time frame: Week 4, 8, 12, 16, 24, and 48]
• The effect of IBI362 on blood pressure reduction efficacy and compliance compared to placebo was evaluated at each node during treatment. [Time frame: Week 4, 8, 12, 16, 24, and 48]
• The effect of IBI362 on blood pressure reduction efficacy and compliance compared to placebo was evaluated at each node during treatment. [Time frame: Week 4, 8, 12, 16, 24, and 48]
• The effects of IBI362 on 24-hour of Ambulatory Blood Pressure Monitoring (ABPM) compared with placebo were evaluated at each node during treatment. [Time frame: Week 8, 12, 16, 24, and 48]
• The effects of IBI362 on day-to-night mean SBP and mean DBP of Ambulatory Blood Pressure Monitoring (ABPM) compared with placebo were evaluated at each node during treatment. [Time frame: Week 8, 12, 16, 24, and 48]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Self-reported body weight change > 5 kg within 3 months.
• 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.
• 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.
• 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).
• 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.
• History or relevant family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai

Identifiers

NCT: NCT07469800 · CIBI362H301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗