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

Phase 3RecruitingNCT07469800

Innovent Biologics (Suzhou) Co. Ltd.336 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

336

Conditions

Overweight Obesity Hypertensive

Interventions

IBI362DRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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 16

Secondary Outcomes

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 24

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 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.

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 16

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 48

The effects of IBI362 on mean sitting diastolic arterial pressure (msDBP) compared to placebo were evaluated at each node during treatment.

Changes from baseline in msDBP at Weeks4, 8, 12, 16, 24, and 48.

Time frame: Week 4, 8, 12, 16, 24, and 48

Central Contacts

Jie Wei

CONTACT

0512-69566088 jie.wei@innoventbio.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

The effects of IBI362 on mean arterial pressure (MAP) compared to placebo were evaluated at each node during treatment.

At Weeks 4, 8, 12, 16, 24, and 48, the change of MAP from baseline.

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.

At weeks 4, 8, 12, 16, 24, 48, the proportion of participants with an effective rate of msSBP \<140 mmHg and msDBP\<90 mmHg, or a reduction of ≥20 mmHg from baseline in msSBP and/or a decrease in diastolic blood pressure of ≥10 mmHg from baseline in msDBP and not on risk-based salvage therapy.

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.

At weeks 4, 8, 12, 16, 24, and 48, the rate of blood pressure reduction: the proportion of participants with msSBP\<140 mmHg and msDBP\<90 mmHg without risk-based salvage therapy.

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.

Proportion of participants initiating risk-based remedial treatment at each visit.

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.

Proportion of participants initiating remedial treatment based on blood pressure compliance at each visit.

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.

At weeks 8, 12, 16, 24, and 48, the average SBP and mean DBP were changed from baseline during the whole monitoring period monitored by ABPM.

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.

Changes from baseline in daytime and nighttime mean SBP and mean DBP monitored by ABPM at weeks 8, 12, 16, 24, and 48.

Time frame: Week 8, 12, 16, 24, and 48

During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo.

Percent change in body weight from baseline at week 48.

Time frame: Week 48

During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo.

At 16, 24, and 48 weeks, changes in weight from baseline.