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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 treatment Group | Experimental |
| |
| Placebo Control Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI362 | Drug | IBI362 will be administered subcutaneously once weekly (QW) in a step-up dose titration regimen over 48 weeks:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| To evaluate the effect of IBI362 on body weight compared with placebo at Weeks 16 and 24 of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wei | Contact | 0512-69566088 | jie.wei@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| Placebo | Drug | 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. |
|
Percent change from baseline in body weight at Weeks 16 and 24. |
| 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. | 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. | 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. | Week 4, 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. | At Weeks 4, 8, 12, 16, 24, and 48, the change of MAP from baseline. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| 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. | Week 16, 24, and 48 |
| During treatment, IBI362 was evaluated for the effects of IBI362 on cystatin-C compared with placebo. | Week 16, 24, and 48 | Change from baseline in cystatin-C at 16, 24, and 48 weeks. |
| 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. | Week 16, 24, and 48 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |