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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 4,008
- Locations
- 1
- Primary Endpoint
- Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Lorcaserin 10 mg QD
Lorcaserin 10 mg tablet each morning and placebo tablet each evening
Intervention: Lorcaserin 10 mg once daily (QD) (Drug)
Lorcaserin 10 mg BID
Lorcaserin 10 mg tablet each morning and evening
Intervention: Lorcaserin 10 mg twice a day (BID) (Drug)
Matching Placebo
Matching placebo tablet each morning and evening
Intervention: Matching Placebo (Drug)
Outcomes
Primary Outcomes
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
Time Frame: Baseline and Week 52
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Secondary Outcomes
- Percent Change in Body Weight From Baseline to Week 52(Baseline and Week 52)