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| Name | Class |
|---|---|
| TFS Trial Form Support | INDUSTRY |
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The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | THR-4109: 115 mg orally in am, 115 mg orally in pm for 24 weeks |
|
| 2 | Experimental | THR-4109: 100 mg orally in am, 100 mg orally in pm for 24 weeks |
|
| 3 | Experimental | THR-4109: 15 mg orally in am, 15 mg orally in pm for 24 weeks |
|
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THR-4109 | Drug | THR-4109 maximum dose in study is 115 mg via oral capsule daily in a.m. and 115 mg via oral capsule daily in p.m. for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline weight | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve weight loss of at least 5% and at least 10% of baseline body weight | 24 weeks | |
| Serum lipids, waist circumference, fasting plasma glucose and blood pressure | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie J Warner, MD | Theracos, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site #62 | Arkhangelsk | 163045 | Russia | |||
| Investigational Site #61 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Oral capsules daily in a.m. and in p.m. for 24 weeks |
|
| Safety and tolerability of THR-4109 | 24 weeks |
| Moscow |
| 107014 |
| Russia |
| Investigational Site #51 | Moscow | 117036 | Russia |
| Investigational Site #60 | Moscow | 121069 | Russia |
| Investigational Site #57 | Moscow | 123056 | Russia |
| Investigational Site #50 | Moscow | 125315 | Russia |
| Investigational Site #54 | Moscow | 129010 | Russia |
| Investigational Site #63 | Saint Petersburg | 192283 | Russia |
| Investigational Site #67 | Saint Petersburg | 194291 | Russia |
| Investigational Site #53 | Saint Petersburg | 194354 | Russia |
| Investigational Site #66 | Saint Petersburg | 194354 | Russia |
| Investigational Site #59 | Saint Petersburg | 195267 | Russia |
| Investigational Site #65 | Saint Petersburg | 197110 | Russia |
| Investigational Site #55 | Saint Petersburg | 197198 | Russia |
| Investigational Site #58 | Saint Petersburg | 198134 | Russia |
| Investigational Site #64 | Saint Petersburg | 199178 | Russia |
| Investigational Site #56 | Saratov | 410018 | Russia |
| Investigational Site #12 | Dalby | SE-240 10 | Sweden |
| Investigational Site #11 | Gothenburg | SE-411 36 | Sweden |
| Investigational Site #13 | Malmö | SE-205 02 | Sweden |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |