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The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.
Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin 10 mg QD | Experimental | Lorcaserin 10 mg tablet each morning and placebo tablet each evening |
|
| Lorcaserin 10 mg BID | Experimental | Lorcaserin 10 mg tablet each morning and evening |
|
| Matching Placebo | Placebo Comparator | Matching placebo tablet each morning and evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin 10 mg once daily (QD) | Drug | Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight From Baseline to Week 52 | The percent change in body weight (kg) from baseline to week 52. | Baseline and Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arena Pharmaceuticals, Inc. | San Diego | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27888609 | Derived | Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26. | |
| 27659698 | Derived | Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19. |
| Label | URL |
|---|---|
| Arena Pharmaceuticals, Inc. Home Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lorcaserin 10 mg QD | lorcaserin 10 mg once daily (QD) tablets |
| FG001 | Lorcaserin 10 mg BID | lorcaserin 10 mg twice a day (BID) tablets |
| FG002 | Matching Placebo | matching placebo tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lorcaserin 10 mg QD | lorcaserin 10 mg QD tablets |
| BG001 | Lorcaserin 10 mg BID | lorcaserin 10 mg BID tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks. | Modified Intent to Treat (MITT) with last observation carried forward (LOCF) | Posted | Number | percentage of participants | Baseline and Week 52 |
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lorcaserin 10 mg QD | lorcaserin 10 mg QD tablets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | +1-888-274-2378 | esi_medinfo@eisai.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D012891 | Sleep Apnea Syndromes |
| D002318 | Cardiovascular Diseases |
| 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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| Lorcaserin 10 mg twice a day (BID) | Drug | Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. |
|
|
| Matching Placebo | Drug | Matching placebo tablet each morning and evening for a duration of 52 weeks. |
|
| 27206567 | Derived | Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17. |
| 27116910 | Derived | Nesto R, Fain R, Li Y, Shanahan W. Evaluation of lorcaserin on progression of prediabetes to type 2 diabetes and reversion to euglycemia. Postgrad Med. 2016 May;128(4):364-70. doi: 10.1080/00325481.2016.1178590. |
| 23661689 | Derived | Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9. |
| 21795446 | Derived | Fidler MC, Sanchez M, Raether B, Weissman NJ, Smith SR, Shanahan WR, Anderson CM; BLOSSOM Clinical Trial Group. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial. J Clin Endocrinol Metab. 2011 Oct;96(10):3067-77. doi: 10.1210/jc.2011-1256. Epub 2011 Jul 27. |
| BG002 |
| Matching Placebo |
matching placebo tablets |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Matching Placebo |
matching placebo tablets |
|
|
|
| Secondary | Percent Change in Body Weight From Baseline to Week 52 | The percent change in body weight (kg) from baseline to week 52. | MITT with LOCF | Posted | Least Squares Mean | Standard Error | % change from baseline: body wt (kg) | Baseline and Week 52 |
|
|
|
|
| 27 |
| 801 |
| 653 |
| 801 |
| EG001 | Lorcaserin 10 mg BID | lorcaserin 10 mg BID tablets | 49 | 1,602 | 1,323 | 1,602 |
| EG002 | Matching Placebo | matching placebo tablets | 36 | 1,601 | 1,205 | 1,601 |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Alcoholic psychosis | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypoaesthesia facial | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Anthropod bite | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Acute psychosis | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Cellulitis staphylococcal | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Uterine mass | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Oral mucosal hypertrophy | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ovarian necrosis | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ovarian torsion | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Tethered cord syndrome | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cystocele | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Enterocele | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rectocele | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Bladder cancer stage I, with cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
Publication of study results are only allowed with prior written consent from Arena Pharmaceuticals, Inc.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |