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This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 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 |
|---|---|---|---|
| HDM1005 Cohort 1 | Experimental |
| |
| HDM1005 Cohort 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1005 1 | Drug | Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total. |
| Measure | Description | Time Frame |
|---|---|---|
| primary outcome | The percentage change in body weight from baseline to week 40 | week 40 |
| Co-primary outcome | Proportion of subjects with body weight reduction ≥ 5% at Week 40. | week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| secondary outcome | The proportion of participants reaching a body weight loss of at least 10% and 15% at week 40 | week 40 |
| secondary outcome | Change in waist circumference, body weight and BMI at week 40 |
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Inclusion Criteria:
Exclusion Criteria:
Male or female aged 18 years or above at the time of signing the informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Qiao | Contact | +86 0571-89908523 | qiaohui@eastchinapharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoying Li | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hoapital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| HDM1005 2 | Drug | Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total. |
|
| Placebo | Drug | Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total. |
|
| week 40 |
| secondary outcome | Change in waist circumference, body weight and BMI at week 52 | week 52 |
| secondary outcome | Change in systolic blood pressure (SBP), diastolic blood pressure (DBP) and lipids at week 40 | week 40 |
| secondary outcome | Change in SBP, DBP and lipids at week 52 | week 52 |
| safety outcome | the incidence of adverse events | week 52 |
| patient report outcome | 36-Item Short Form Health Survey, Version 2 questionnaire (scores range from 0 to 100, with higher scores indicating better health status) after administration for 52 weeks. | week 52 |
| Immunogenicity outcome | ADA and NAb | week 52 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |