BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00603902
• Collaborator: (none)
• Enrollment: 4,008
• Location: 1
• Arms: 3
• Duration (Months): 19
• Patients Per Site Per Month: 211.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Lorcaserin 10 mg once daily (QD); Drug: Lorcaserin 10 mg twice a day (BID); Drug: Matching Placebo	Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4008 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lorcaserin 10 mg QD Lorcaserin 10 mg tablet each morning and placebo tablet each evening	Drug: Lorcaserin 10 mg once daily (QD); Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.; Other Names: APD356
Experimental: Lorcaserin 10 mg BID Lorcaserin 10 mg tablet each morning and evening	Drug: Lorcaserin 10 mg twice a day (BID); Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.; Other Names: APD356
Placebo Comparator: Matching Placebo Matching placebo tablet each morning and evening	Drug: Matching Placebo; Matching placebo tablet each morning and evening for a duration of 52 weeks.

Outcome Measures

Primary Outcome Measures

1. Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 [Baseline and Week 52]

   The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

Secondary Outcome Measures

1. Percent Change in Body Weight From Baseline to Week 52 [Baseline and Week 52]

   The percent change in body weight (kg) from baseline to week 52.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.

• Ability to complete a 1 year study

Exclusion Criteria:

• Pregnancy

• Diabetes mellitus (type I, II or other)

• History of symptomatic heart valve disease

• Serious or unstable current or past medical conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arena Pharmaceuticals, Inc.	San Diego	California	United States	92121

Sponsors and Collaborators

• Eisai Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Arena Pharmaceuticals, Inc. Home Page

Publications

None provided.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT00603902
• Other Study ID Numbers: APD356-011
• First Posted: Jan 29, 2008
• Last Update Posted: Oct 4, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Eisai Inc.: Obesity; Weight loss; lorcaserin; APD356; BLOSSOM; Hypertension; Dyslipidemia; Sleep apnea; glucose tolerance; cardiovascular disease; Arena
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Lorcaserin 10 mg QD	Lorcaserin 10 mg BID	Matching Placebo
Arm/Group Description	lorcaserin 10 mg once daily (QD) tablets	lorcaserin 10 mg twice a day (BID) tablets	matching placebo tablets
Period Title: Overall Study
STARTED	802	1603	1603
COMPLETED	473	917	834
NOT COMPLETED	329	686	769

Baseline Characteristics

Arm/Group Title	Lorcaserin 10 mg QD	Lorcaserin 10 mg BID	Matching Placebo	Total
Arm/Group Description	lorcaserin 10 mg QD tablets	lorcaserin 10 mg BID tablets	matching placebo tablets	Total of all reporting groups
Overall Participants	801	1602	1601	4004
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.8 (11.66)	43.8 (11.81)	43.7 (11.76)	43.8 (11.76)
Sex: Female, Male (Count of Participants)
Female	656 81.9%	1289 80.5%	1249 78%	3194 79.8%
Male	145 18.1%	313 19.5%	352 22%	810 20.2%

Outcome Measures

1. Primary Outcome

Title	Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
Description	The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat (MITT) with last observation carried forward (LOCF)

Arm/Group Title	Lorcaserin 10 mg QD	Lorcaserin 10 mg BID	Matching Placebo
Arm/Group Description	lorcaserin 10 mg QD tablets	lorcaserin 10 mg BID tablets	matching placebo tablets
Measure Participants	771	1561	1541
Number [percentage of participants]	40.2 5%	47.2 2.9%	25.0 1.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lorcaserin 10 mg BID, Matching Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments	Adjustments for baseline body weight.
Method of Estimation	Estimation Parameter	Odds Ratio, log
	Estimated Value	2.69
	Confidence Interval	(2-Sided) 95%; 2.31 to 3.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percent Change in Body Weight From Baseline to Week 52
Description	The percent change in body weight (kg) from baseline to week 52.
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

MITT with LOCF

Arm/Group Title	Lorcaserin 10 mg QD	Lorcaserin 10 mg BID	Matching Placebo
Arm/Group Description	lorcaserin 10 mg QD tablets	lorcaserin 10 mg BID tablets	matching placebo tablets
Measure Participants	771	1561	1541
Least Squares Mean (Standard Error) [% change from baseline: body wt (kg)]	-4.75 (0.23)	-5.84 (0.16)	-2.84 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lorcaserin 10 mg BID, Matching Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.00
	Confidence Interval	(2-Sided) 95%; -3.44 to -2.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	52 weeks
Arm/Group Title	Lorcaserin 10 mg QD		Lorcaserin 10 mg BID		Matching Placebo
Arm/Group Description	lorcaserin 10 mg QD tablets		lorcaserin 10 mg BID tablets		matching placebo tablets
All Cause Mortality
	Lorcaserin 10 mg QD		Lorcaserin 10 mg BID		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Lorcaserin 10 mg QD		Lorcaserin 10 mg BID		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/801 (3.4%)		49/1602 (3.1%)		36/1601 (2.2%)
Blood and lymphatic system disorders
Lymphadenopathy	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Cardiac disorders
Acute myocardial infarction	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Angina pectoris	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Acute coronary syndrome	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Myocardial infarction	0/801 (0%)	0	3/1602 (0.2%)	3	0/1601 (0%)	0
Syncope	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Pericarditis	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Atrial fibrillation	1/801 (0.1%)	2	0/1602 (0%)	0	0/1601 (0%)	0
Sick sinus syndrome	1/801 (0.1%)	2	0/1602 (0%)	0	0/1601 (0%)	0
Palpitations	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Coronary artery disease	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Ventricular tachycardia	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Ear and labyrinth disorders
Vertigo	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Gastrointestinal disorders
Small intestinal obstruction	1/801 (0.1%)	1	1/1602 (0.1%)	1	2/1601 (0.1%)	2
Nausea	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Vomiting	0/801 (0%)	0	1/1602 (0.1%)	1	1/1601 (0.1%)	1
Intestinal perforation	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Appendicitis	0/801 (0%)	0	1/1602 (0.1%)	1	2/1601 (0.1%)	2
Gastroenteritis	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Abdominal pain	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Oral mucosal hypertrophy	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Gastritis	2/801 (0.2%)	2	0/1602 (0%)	0	0/1601 (0%)	0
Diverticulitis	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Enterocele	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Rectocele	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Diarrhoea	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
General disorders
Chest pain	0/801 (0%)	0	1/1602 (0.1%)	1	1/1601 (0.1%)	1
Non-cardiac chest pain	1/801 (0.1%)	1	1/1602 (0.1%)	1	0/1601 (0%)	0
Chest discomfort	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Hepatobiliary disorders
Cholelithiasis	2/801 (0.2%)	2	2/1602 (0.1%)	2	1/1601 (0.1%)	1
Biliary dyskinesia	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Cholecystitis	0/801 (0%)	0	3/1602 (0.2%)	3	0/1601 (0%)	0
Immune system disorders
Anaphylactic reaction	0/801 (0%)	0	0/1602 (0%)	0	2/1601 (0.1%)	2
Infections and infestations
Pneumonia	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Meningitis aseptic	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Cellulitis	0/801 (0%)	0	3/1602 (0.2%)	3	0/1601 (0%)	0
Urinary tract infection	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Abscess limb	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Cellulitis staphylococcal	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Viral infection	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Bronchitis	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Pneumonia viral	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Injury, poisoning and procedural complications
Meniscus lesion	1/801 (0.1%)	1	1/1602 (0.1%)	1	0/1601 (0%)	0
Anthropod bite	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Hand fracture	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Animal bite	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Splenic rupture	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Back injury	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Foot fracture	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Tibia fracture	1/801 (0.1%)	1	0/1602 (0%)	0	1/1601 (0.1%)	1
Tendon rupture	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Hip fracture	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Ankle fracture	0/801 (0%)	0	0/1602 (0%)	0	2/1601 (0.1%)	2
Joint dislocation	0/801 (0%)	0	0/1602 (0%)	0	2/1601 (0.1%)	2
Fibula fracture	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Investigations
Heart rate increased	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Muscular weakness	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Osteoarthritis	1/801 (0.1%)	1	1/1602 (0.1%)	2	2/1601 (0.1%)	2
Intervertebral disc protrusion	0/801 (0%)	0	1/1602 (0.1%)	1	1/1601 (0.1%)	1
Back pain	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Arthralgia	1/801 (0.1%)	1	1/1602 (0.1%)	1	0/1601 (0%)	0
Psoriatic arthropathy	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Intervertebral disc displacement	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Lumbar spinal stenosis	2/801 (0.2%)	2	0/1602 (0%)	0	1/1601 (0.1%)	1
Arthritis	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Spinal osteoarthritis	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/801 (0%)	0	2/1602 (0.1%)	2	0/1601 (0%)	0
Lung adenocarcinoma	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Uterine leiomyoma	1/801 (0.1%)	1	1/1602 (0.1%)	1	0/1601 (0%)	0
Neuroendocrine carcinoma	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Multiple myeloma	0/801 (0%)	0	2/1602 (0.1%)	2	0/1601 (0%)	0
Prostate cancer	1/801 (0.1%)	1	0/1602 (0%)	0	1/1601 (0.1%)	1
Thyroid neoplasm	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Ovarian adenoma	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Parathyroid tumour benign	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Metastatic squamous cell carcinoma	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Haemangioma	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Transitional cell carcinoma	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Bladder cancer stage I, with cancer in situ	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Nervous system disorders
Hypoaesthesia facial	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Syncope	0/801 (0%)	0	1/1602 (0.1%)	1	1/1601 (0.1%)	1
Migraine	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Transient ischaemic attack	1/801 (0.1%)	1	0/1602 (0%)	0	1/1601 (0.1%)	1
Haemorrhage intracranial	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Tethered cord syndrome	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Cerebral ischaemia	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Radiculopathy	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Lumbar radiculopathy	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Psychiatric disorders
Alcoholic psychosis	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Mental disorder	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Suicidal ideation	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Depression	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Acute psychosis	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Renal and urinary disorders
Cystocele	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Reproductive system and breast disorders
Menorrhagia	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Dysmenorrhoea	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Uterine prolapse	0/801 (0%)	0	1/1602 (0.1%)	1	1/1601 (0.1%)	1
Uterine mass	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Cervical dysplasia	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Pelvic prolapse	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Ovarian necrosis	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Ovarian torsion	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/801 (0%)	0	2/1602 (0.1%)	2	0/1601 (0%)	0
Pleural effusion	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Nasal turbinate hypertrophy	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Tonsillar hypertrophy	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Nasal septum deviation	1/801 (0.1%)	1	0/1602 (0%)	0	0/1601 (0%)	0
Pulmonary embolism	0/801 (0%)	0	0/1602 (0%)	0	1/1601 (0.1%)	1
Asthma	0/801 (0%)	0	0/1602 (0%)	0	3/1601 (0.2%)	3
Vascular disorders
Hypertension	0/801 (0%)	0	1/1602 (0.1%)	1	0/1601 (0%)	0
Other (Not Including Serious) Adverse Events
	Lorcaserin 10 mg QD		Lorcaserin 10 mg BID		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	653/801 (81.5%)		1323/1602 (82.6%)		1205/1601 (75.3%)
Gastrointestinal disorders
Nausea	61/801 (7.6%)	68	145/1602 (9.1%)	160	85/1601 (5.3%)	96
Diarrhoea	53/801 (6.6%)	59	98/1602 (6.1%)	119	94/1601 (5.9%)	106
Constipation	41/801 (5.1%)	44	80/1602 (5%)	91	61/1601 (3.8%)	62
Dry mouth	27/801 (3.4%)	29	87/1602 (5.4%)	90	37/1601 (2.3%)	41
General disorders
Fatigue	53/801 (6.6%)	59	134/1602 (8.4%)	147	66/1601 (4.1%)	71
Infections and infestations
Upper respiratory tract infection	117/801 (14.6%)	142	204/1602 (12.7%)	247	202/1601 (12.6%)	238
Nasopharyngitis	95/801 (11.9%)	123	201/1602 (12.5%)	240	192/1601 (12%)	240
Sinusitis	67/801 (8.4%)	77	122/1602 (7.6%)	141	118/1601 (7.4%)	132
Urinary tract infection	61/801 (7.6%)	80	107/1602 (6.7%)	131	77/1601 (4.8%)	84
Musculoskeletal and connective tissue disorders
Back pain	55/801 (6.9%)	60	101/1602 (6.3%)	107	91/1601 (5.7%)	107
Nervous system disorders
Headache	125/801 (15.6%)	158	250/1602 (15.6%)	293	147/1601 (9.2%)	172
Dizziness	50/801 (6.2%)	58	140/1602 (8.7%)	169	62/1601 (3.9%)	72

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication of study results are only allowed with prior written consent from Arena Pharmaceuticals, Inc.