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OverweightPhase 3NCT07469800

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

A Phase 3 study testing IBI362 in people with Overweight and Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity, Hypertensive
What is being tested?
IBI362
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
336 participants
Where
1 siteChina
Study dates
23 Apr 2026to 15 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

    Weiwei Jiang, 021-64150275, gcp@rjh.com.cn

    Recruiting

Other trials in China

About this study

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

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

Being tested
IBI362, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07469800
Study groupRoleWhat they receive
IBI362 treatment GroupExperimentalNot described
Receives: Drug: IBI362
Placebo Control GroupPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 16

Secondary outcomes (30)
  1. 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.

    Measured: Week 24

  2. 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.

    Measured: Week 16 and Week 24

  3. 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.

    Measured: Week 16

  4. 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.

    Measured: Week 4, 8, 12, and 48

  5. 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.

    Measured: Week 4, 8, 12, 16, 24, and 48

  6. 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.

    Measured: Week 4, 8, 12, 16, 24, and 48

  7. 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.

    Measured: Week 4, 8, 12, 16, 24, 48

  8. 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.

    Measured: Week 4, 8, 12, 16, 24, and 48

  9. 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.

    Measured: Week 4, 8, 12, 16, 24, and 48

  10. 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.

    Measured: Week 4, 8, 12, 16, 24, and 48

  11. 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.

    Measured: Week 8, 12, 16, 24, and 48

  12. 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.

    Measured: Week 8, 12, 16, 24, and 48

  13. 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.

    Measured: Week 48

  14. 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.

    Measured: Week 16, 24, and 48

  15. During treatment, IBI362 was evaluated for the effects of IBI362 on body mass index (BMI) compared with placebo.

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

    Measured: Week 16, 24, and 48

  16. During treatment, IBI362 was evaluated for the effects of IBI362 on waist circumference compared with placebo.

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

    Measured: Week 16, 24, and 48

  17. During treatment, IBI362 was evaluated for the effects of IBI362 on fasting blood glucose compared with placebo.

    At 16, 24, and 48 weeks, fasting blood glucose changed from baseline.

    Measured: Week 16, 24, and 48

  18. During treatment, IBI362 was evaluated for the effects of IBI362 on glycated hemoglobin (HbA1c) compared with placebo.

    At 16, 24, and 48 weeks, HbA1c changed from baseline.

    Measured: Week 16, 24, and 48

  19. During treatment, IBI362 was evaluated for the effects of IBI362 on total cholesterol (TC).

    Changes from baseline in total cholesterol (TC) at 16, 24, and 48 weeks.

    Measured: Week 16, 24, and 48

  20. During treatment, IBI362 was evaluated for the effects of IBI362 on low-density lipoprotein cholesterol (LDL-C) compared with placebo.

    Changes from baseline in low-density lipoprotein cholesterol (LDL-C) at 16, 24, and 48 weeks.

    Measured: Week 16, 24, and 48

  21. During treatment, IBI362 was evaluated for the effects of IBI362 on high-density lipoprotein cholesterol (HDL-C) compared with placebo.

    Changes from baseline in high-density lipoprotein cholesterol (HDL-C) at 16, 24, and 48 weeks.

    Measured: Week 16, 24, and 48

  22. During treatment, IBI362 was evaluated for the effects of IBI362 on non-high-density lipoprotein (non-HDL-C) compared with placebo.

    Changes from baseline in non-high-density lipoprotein (non-HDL-C) at 16, 24, and 48 weeks.

    Measured: Week 16, 24, and 48

  23. During treatment, IBI362 was evaluated for the effects of IBI362 on very low-density lipoprotein cholesterol (VLDL-C) compared with placebo.

    Changes from baseline in very low-density lipoprotein cholesterol (VLDL-C) at 16, 24, and 48 weeks.

    Measured: Week 16, 24, and 48

  24. During treatment, IBI362 was evaluated for the effects of IBI362 on triglycerides (TG) compared with placebo.

    Changes from baseline in triglycerides (TG) at 16, 24, and 48 weeks.

    Measured: Week 16, 24, and 48

  25. During treatment, IBI362 was evaluated for the effects of IBI362 on Lp(a) compared with placebo.

    Changes from baseline in Lp(a) at 16, 24, and 48 weeks.

    Measured: Week 16, 24, and 48

  26. During treatment, IBI362 was evaluated for the effects of IBI362 on Apo B compared with placebo.

    Changes from baseline in Apo B at 16, 24, and 48 weeks.

    Measured: Week 16, 24, and 48

  27. During treatment, IBI362 was evaluated for the effects of IBI362 on estimated glomerular filtration rate (eGFR) compared with placebo.

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

    Measured: Week 16, 24, and 48

  28. During treatment, IBI362 was evaluated for the effects of IBI362 on urine protein compared with placebo.

    At weeks 16, 24, and 48, the changes in urine albumin/creatinine ratio from baseline.

    Measured: Week 16, 24, and 48

  29. During treatment, IBI362 was evaluated for the effects of IBI362 on cystatin-C compared with placebo.

    Week 16, 24, and 48

    Measured: Change from baseline in cystatin-C at 16, 24, and 48 weeks.

  30. During treatment, IBI362 was evaluated for the effects of IBI362 on blood uric acid compared with placebo.

    At 16, 24, and 48 weeks, the change in blood uric acid from baseline.

    Measured: Week 16, 24, and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start23 Apr 2026
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
336 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07469800
Sponsor's protocol ID
CIBI362H301
Status last verified
May 2026
First submitted
27 Feb 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IBI362 in people with Overweight and Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie Wei (0512-69566088, jie.wei@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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