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

NCTNCT07469800Other idCIBI362H301

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Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 336 participants (estimated)
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design: Randomized · Double masking
Countries: 1 country
China
Start: 23 Apr 2026
Primary completion: 1 Aug 2026 (estimated)
Completion: 15 Apr 2027 (estimated)
First posted: 13 Mar 2026
Last update posted: 27 May 2026
Conditions: Overweight · Obesity · Hypertensive

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620272028

Ph 3
Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity
NCT07469800
23 Apr 2026 to est. 15 Apr 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

IBI362Drug
PlaceboDrug

Arms2

Experimental
IBI362 treatment Group
Placebo comparator
Placebo Control Group

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
Change from baseline in msSBP at trough (end-of-dosing interval) at Week 16

Secondary outcomes(20)

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
Registry description
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.
Time frame · Week 16 and Week 24
Registry description
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.
Time frame · Week 16
Registry description
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.
Time frame · Week 4, 8, 12, and 48
Registry description
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.
Time frame · Week 4, 8, 12, 16, 24, and 48
Registry description
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.
Time frame · Week 4, 8, 12, 16, 24, and 48
Registry description
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.
Time frame · Week 4, 8, 12, 16, 24, 48
Registry description
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 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
Registry description
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.
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
Registry description
Proportion of participants initiating risk-based remedial treatment at each visit.
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
Registry description
Proportion of participants initiating remedial treatment based on blood pressure compliance at each visit.
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
Registry description
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.
Time frame · Week 8, 12, 16, 24, and 48
Registry description
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.
Time frame · Week 48
Registry description
Percent change in body weight from baseline at week 48.
During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo.
Time frame · Week 16, 24, and 48
Registry description
At 16, 24, and 48 weeks, changes in weight from baseline.
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
Registry description
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.
Time frame · Week 16, 24, and 48
Registry description
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.
Time frame · Week 16, 24, and 48
Registry description
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.
Time frame · Week 16, 24, and 48
Registry description
At 16, 24, and 48 weeks, HbA1c changed from baseline.
During treatment, IBI362 was evaluated for the effects of IBI362 on total cholesterol (TC).
Time frame · Week 16, 24, and 48
Registry description
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.
Time frame · Week 16, 24, and 48
Registry description
Changes from baseline in low-density lipoprotein cholesterol (LDL-C) at 16, 24, and 48 weeks.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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