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The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo BID | Placebo Comparator |
| |
| Lorcaserin 10mg BID | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Lorcaserin 10mg BID |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of lorcaserin on 24h energy metabolism (measured in a respiratory chamber) after 56 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the ongoing safety of lorcaserin |
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Inclusion Criteria:
Exclusion Criteria:
Prior participation in any study of lorcaserin.
Participants who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
Clinically significant new illness in the 1 month before screening
Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
Recent history (within 6 months before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication. SSRI's, SNRI's, and other medications must meet washout requirements.
Significant dislike or allergy to foods used during the food intake tests
History of any of the following cardiovascular conditions:
Positive result of HIV, hepatitis B or hepatitis C screens
Recent treatment (i.e., within 1 month of the screening visit) with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents), or within 3 months with a prescription anti-obesity drug (e.g., phentermine, sibutramine, orlistat)
Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24500151 | Derived | Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5. | |
| 21190985 | Derived | Martin CK, Redman LM, Zhang J, Sanchez M, Anderson CM, Smith SR, Ravussin E. Lorcaserin, a 5-HT(2C) receptor agonist, reduces body weight by decreasing energy intake without influencing energy expenditure. J Clin Endocrinol Metab. 2011 Mar;96(3):837-45. doi: 10.1210/jc.2010-1848. Epub 2010 Dec 29. |
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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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| ID | Term |
|---|---|
| C506658 | lorcaserin |
| C494814 | BID protein, human |
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|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |