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A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
| |
| 5 | Placebo Comparator |
| |
| 6 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC2307 | Drug | subcutaneous, twice daily, low dose |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects | 24 weeks | |
| To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the effect of AC2307 injected SC BID in obese or overweight subjects on the following parameters: waist circumference; gastric emptying rate; fasting circulating metabolic parameters; patient reported outcomes | 24 weeks | |
| To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects |
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Inclusion Criteria:
- Is obese with a body mass index (BMI) ≥30 kg/m^2 to ≤45 kg/m^2, or is overweight with a BMI ≥27 kg/m^2 to <30 kg/m^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert Chen, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
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| Drug |
subcutaneous, twice daily, low dose |
|
| AC2307 | Drug | subcutaneous, twice daily, middle dose |
|
| placebo | Drug | subcutaneous, twice daily, middle dose |
|
| AC2307 | Drug | subcutaneous, twice daily, high dose |
|
| placebo | Drug | subcutaneous, twice daily, high dose |
|
| 24 weeks |
| Chandler |
| Arizona |
| United States |
| Research Site | Santa Rosa | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Butte | Montana | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Eugene | Oregon | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Greer | South Carolina | United States |
| Research Site | Mt. Pleasant | South Carolina | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Olympia | Washington | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| C553163 | davalintide |
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