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This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM1702 | Experimental |
| |
| WEGOVY® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1702 | Drug | Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in body weight from baseline to week 44 | week 44 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants reaching a body weight loss of at least 5%, 10% and 15% at week 44 | week 44 | |
| Change in waist circumference, body weight and BMI at week 44 | week 44 | |
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Inclusion Criteria:
Exclusion Criteria:
Male or female aged 18 years to 75 years (inclusive) at the time of signing the informed consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Statistician, data manager and medical monitor are masked to the randomized allocation.
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| Wegovy ® | Drug | Initiate at a once weekly dose of 0.25 mg and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week) aiming at reaching the maintenance dose of 2.4 mg at week 16. |
|
| Change in blood pressure and lipids at week 44 |
| week 44 |
| Adverse events | week 44 |
| ADA and NAb | week 44 |