Hypertensive, Obesity, Overweight
Conditions
Brief summary
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
DRUGIBI362
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.
DRUGPlacebo
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.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment. | Week 16 | Change from baseline in msSBP at trough (end-of-dosing interval) at Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared with placebo at Week 24 of treatment. | Week 24 | Change from baseline in Mean Sitting Systolic Arterial Pressure(msSBP) at Week 24. |
| To evaluate the effect of IBI362 on body weight compared with placebo at Weeks 16 and 24 of treatment. | Week 16 and Week 24 | Percent change from baseline in body weight at Weeks 16 and 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. | Week 16 | 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. |
| The effects of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared to placebo were evaluated at each node during treatment. | Week 4, 8, 12, and 48 | At Weeks 4, 8, 12, and 48, changes in msSBP from baseline. |
| The effects of IBI362 on mean sitting diastolic arterial pressure (msDBP) compared to placebo were evaluated at each node during treatment. | Week 4, 8, 12, 16, 24, and 48 | Changes from baseline in msDBP at Weeks4, 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. | Week 4, 8, 12, 16, 24, and 48 | At Weeks 4, 8, 12, 16, 24, and 48, the change of MAP from baseline. |
| The effect of IBI362 on blood pressure reduction efficacy and compliance compared to placebo was evaluated at each node during treatment. | Week 4, 8, 12, 16, 24, 48 | 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. |
| The effects of IBI362 on 24-hour of Ambulatory Blood Pressure Monitoring (ABPM) compared with placebo were evaluated at each node during treatment. | Week 8, 12, 16, 24, and 48 | 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. |
| 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. | Week 8, 12, 16, 24, and 48 | Changes from baseline in daytime and nighttime mean SBP and mean DBP monitored by ABPM at weeks 8, 12, 16, 24, and 48. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo. | Week 48 | Percent change in body weight from baseline at week 48. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on body mass index (BMI) compared with placebo. | Week 16, 24, and 48 | At 16, 24, and 48 weeks, changes in BMI from baseline. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on waist circumference compared with placebo. | Week 16, 24, and 48 | At 16, 24, and 48 weeks, changes in waist circumference from baseline. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on fasting blood glucose compared with placebo. | Week 16, 24, and 48 | At 16, 24, and 48 weeks, fasting blood glucose changed from baseline. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on glycated hemoglobin (HbA1c) compared with placebo. | Week 16, 24, and 48 | At 16, 24, and 48 weeks, HbA1c changed from baseline. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on total cholesterol (TC). | Week 16, 24, and 48 | Changes from baseline in total cholesterol (TC) at 16, 24, and 48 weeks. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on low-density lipoprotein cholesterol (LDL-C) compared with placebo. | Week 16, 24, and 48 | Changes from baseline in low-density lipoprotein cholesterol (LDL-C) at 16, 24, and 48 weeks. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on high-density lipoprotein cholesterol (HDL-C) compared with placebo. | Week 16, 24, and 48 | Changes from baseline in high-density lipoprotein cholesterol (HDL-C) at 16, 24, and 48 weeks. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on non-high-density lipoprotein (non-HDL-C) compared with placebo. | Week 16, 24, and 48 | Changes from baseline in non-high-density lipoprotein (non-HDL-C) at 16, 24, and 48 weeks. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on very low-density lipoprotein cholesterol (VLDL-C) compared with placebo. | Week 16, 24, and 48 | Changes from baseline in very low-density lipoprotein cholesterol (VLDL-C) at 16, 24, and 48 weeks. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on triglycerides (TG) compared with placebo. | Week 16, 24, and 48 | Changes from baseline in triglycerides (TG) at 16, 24, and 48 weeks. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on Lp(a) compared with placebo. | Week 16, 24, and 48 | Changes from baseline in Lp(a) at 16, 24, and 48 weeks. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on Apo B compared with placebo. | Week 16, 24, and 48 | Changes from baseline in Apo B at 16, 24, and 48 weeks. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on estimated glomerular filtration rate (eGFR) compared with placebo. | Week 16, 24, and 48 | At weeks 16, 24, and 48, the changes in eGFR from baseline. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on urine protein compared with placebo. | Week 16, 24, and 48 | At weeks 16, 24, and 48, the changes in urine albumin/creatinine ratio from baseline. |
| During treatment, IBI362 was evaluated for the effects of IBI362 on cystatin-C compared with placebo. | Change from baseline in cystatin-C at 16, 24, and 48 weeks. | Week 16, 24, and 48 |
| During treatment, IBI362 was evaluated for the effects of IBI362 on blood uric acid compared with placebo. | Week 16, 24, and 48 | At 16, 24, and 48 weeks, the change in blood uric acid from baseline. |
Countries
China
Contacts
CONTACTJie Wei
Outcome results
None listed