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The purpose of this study is to determine the optimal dose and regimen of HM11260C, in combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise considered in stable health.
Phase 2 study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM11260C | Experimental | HM11260C 4 mg weekly sc injection |
|
| Placebo | Placebo Comparator | Placebo weekly sc injection |
|
| HM11260C 6 mg/week | Experimental | HM11260C 6 mg weekly sc injection |
|
| HM11260C 6 mg/biweekly | Experimental | HM11260C 6 mg biweekly sc injection |
|
| HM11260C 8 mg/biweekly | Experimental | HM11260C 8 mg biweekly sc injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM11260C | Biological | Glucagon-like peptide-1 analogue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight at 20 weeks | 20 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse event | during 20 weeks of treatment and follow-up period | |
| Change from baseline in HbA1c and fasting plasma glucose level at 20 week | 20 weeks from baseline | |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in waist circumference at 20 week | 20 weeks after baseline | |
| Change from baseline in β-cell function at 20 week | homeostatic model assessment | 20 week from baseline |
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hanmi pharmaceuticals Hanmi pharmaceuticals | Hanmi pharmaceuticals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi pharmaceutical | Los Angeles | California | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Biological |
|
| Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week |
Cholesterol level, LDL-C level |
| 20 weeks from baseline |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |