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Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity
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
Lead sponsor
Asset
Mazdutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
1
Recruiting sites
1
Enrollment
336
estimated
Study population
Hypertension, Obesity / overweight
Key I/E criterion
—
Primary endpoint
•Systolic BP, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (31)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
5 endpointsTo 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
Body weight, % change
percent change from baseline, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo.
Time frame:Week 48
Body weight, % change
percent change from baseline, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo.
Time frame:Week 16, 24, and 48
Body weight, absolute change (kg)
change from baseline, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on body mass index (BMI) compared with placebo.
Time frame:Week 16, 24, and 48
BMI, change
change from baseline, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on waist circumference compared with placebo.
Time frame:Week 16, 24, and 48
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
2 endpointsDuring treatment, IBI362 was evaluated for the effects of IBI362 on fasting blood glucose compared with placebo.
Time frame:Week 16, 24, and 48
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
During treatment, IBI362 was evaluated for the effects of IBI362 on glycated hemoglobin (HbA1c) compared with placebo.
Time frame:Week 16, 24, and 48
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Renal / kidney
3 endpointsDuring treatment, IBI362 was evaluated for the effects of IBI362 on estimated glomerular filtration rate (eGFR) compared with placebo.
Time frame:Week 16, 24, and 48
eGFR, change
change from baseline, improvement
LOINC 98979-8
During treatment, IBI362 was evaluated for the effects of IBI362 on urine protein compared with placebo.
Time frame:Week 16, 24, and 48
uACR, change
change from baseline, improvement
LOINC 9318-7
During treatment, IBI362 was evaluated for the effects of IBI362 on cystatin-C compared with placebo.
Time frame:Change from baseline in cystatin-C at 16, 24, and 48 weeks.
change from baseline, improvement
Cardiometabolic biomarkers
19 endpointsTo evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment.
Time frame:Week 16
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
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
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
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
ratio, improvement
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
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
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
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
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
Mean arterial pressure
change from baseline, improvement
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
threshold achievement, improvement
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
threshold achievement, improvement
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
threshold achievement, improvement
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
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
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
change from baseline, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on total cholesterol (TC).
Time frame:Week 16, 24, and 48
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
During treatment, IBI362 was evaluated for the effects of IBI362 on low-density lipoprotein cholesterol (LDL-C) compared with placebo.
Time frame:Week 16, 24, and 48
LDL-C, change
change from baseline, improvement
LOINC 13457-7
During treatment, IBI362 was evaluated for the effects of IBI362 on high-density lipoprotein cholesterol (HDL-C) compared with placebo.
Time frame:Week 16, 24, and 48
HDL-C, change
change from baseline, improvement
LOINC 2085-9
During treatment, IBI362 was evaluated for the effects of IBI362 on non-high-density lipoprotein (non-HDL-C) compared with placebo.
Time frame:Week 16, 24, and 48
Non-HDL cholesterol, change
change from baseline, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on very low-density lipoprotein cholesterol (VLDL-C) compared with placebo.
Time frame:Week 16, 24, and 48
VLDL, change
change from baseline, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on triglycerides (TG) compared with placebo.
Time frame:Week 16, 24, and 48
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
During treatment, IBI362 was evaluated for the effects of IBI362 on Lp(a) compared with placebo.
Time frame:Week 16, 24, and 48
change from baseline, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on Apo B compared with placebo.
Time frame:Week 16, 24, and 48
ApoB, change
change from baseline, improvement
Other (unclassified)
2 endpointsThe 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
threshold achievement, improvement
During treatment, IBI362 was evaluated for the effects of IBI362 on blood uric acid compared with placebo.
Time frame:Week 16, 24, and 48
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.