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The purpose of this study is to compare the safety and effect of HPP404 versus placebo on body weight in overweight or obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPP404 35 mg | Experimental |
| |
| HPP404 50 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPP404 | Drug | Administered orally once daily for 26 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent weight loss | Day 1 to Day 182 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects attaining a 5% or more weight loss | Day 1 to Day 182 | |
| Absolute and percent change in Body Mass Index (BMI) | Day 1 to Day 182 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrikas Vainorius, M.D. | High Point Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 11 | Augusta | Georgia | 30909 | United States | ||
| Site 3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39952695 | Derived | Kokkorakis M, Chakhtoura M, Rhayem C, Al Rifai J, Ghezzawi M, Valenzuela-Vallejo L, Mantzoros CS. Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22. |
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| Placebo |
| Drug |
Administered orally once daily for 26 weeks |
|
| Valparaiso |
| Indiana |
| 46383 |
| United States |
| Site 12 | Louisville | Kentucky | 40213 | United States |
| Site 9 | Hyannis | Massachusetts | 02601 | United States |
| Site 10 | Saint Paul | Minnesota | 55114 | United States |
| Site 2 | New York | New York | 10065 | United States |
| Site 1 | Charlotte | North Carolina | 28277 | United States |
| Site 5 | High Point | North Carolina | 27265 | United States |
| Site 7 | Norfolk | Virginia | 23502 | United States |
| Site 6 | Richmond | Virginia | 23294 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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 |
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