A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults
- Conditions
- Chronic Weight Management
- Interventions
- Registration Number
- NCT01987427
- Lead Sponsor
- Eisai Inc.
- Brief Summary
APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of 12-week duration in overweight and obese adults. Approximately 225 subjects will be randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15 mg once daily (QD), or lorcaserin alone.
- Detailed Description
All subjects will take lorcaserin and phentermine-HCl/placebo once in the morning and again in the mid-afternoon. The dosing is timed to help reduce potential insomnia due to phentermine. Subjects in Arm A will take one tablet twice daily of lorcaserin 10 mg in combination with one capsule twice daily of phentermine placebo. Subjects in Arm B will take one tablet twice daily of lorcaserin 10 mg, one capsule of phentermine-HCl 15 mg once daily in the morning, and one capsule of phentermine placebo once daily in the mid-afternoon. Subjects in Arm C will take one tablet twice daily of lorcaserin 10 mg in combination with one capsule twice daily of phentermine-HCl 15 mg. Subjects will be instructed to take lorcaserin tablets and phentermine/placebo capsules concurrently and attempt to remain on a consistent daily schedule. The study will recruit obese (body mass index \[BMI\] greater than or equal to 30 kg/m2) subjects with or without a weight-related comorbid condition (e.g., hypertension, dyslipidemia, or sleep apnea) or overweight (BMI greater than or equal to 27 to 29.9 kg/m2) subjects with at least one weight-related co-morbid condition. At least one third of the subjects will have a BMI of 40 kg/m2 or greater, because there is a high likelihood that this combination therapy will be used by these subjects in medical practice.
A lifestyle intervention program, using a 12-week adaptation of the Arena Healthy Lifestyles Program, including diet and exercise counseling, will be implemented for obesity/overweight.
Blood sampling will be performed to evaluate the pharmacokinetics (PK) of lorcaserin and phentermine using population PK modeling as well as the potential relationships between exposure to the lorcaserin/phentermine and measures of safety and change from baseline in body weight, using population PK/PD (pharmacodynamics) modeling.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B lorcaserin + phentermine-HCl + phentermine placebo lorcaserin + phentermine-HCl + phentermine placebo A lorcaserin + phentermine placebo lorcaserin + phentermine placebo C lorcaserin + phentermine-HCl lorcaserin + phentermine-HCl
- Primary Outcome Measures
Name Time Method Percentage of Participants Reporting at Least One of Nine Adverse Events (AEs) of Main Interests That May Related to Serotonergic Reaction Baseline up to Week 12 (end of treatment) The nine common serotonergic AEs were headache, dizziness, nausea, fatigue, dry mouth, diarrhea, vomiting, insomnia, and/or anxiety.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and AEs Leading to Study Drug Discontinuation Baseline up to Week 16 Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values Baseline up to Week 16 Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12 Baseline, Weeks 1, 2, 4, 8 and 12 Percentage of Participants Who Achieved Greater Than or Equal to (>=) 5 Percent (%) Weight Reduction at Week 12 Week 12 (end of treatment) Change From Baseline in Waist Circumference and Hip Circumference at Week 12 Baseline and Week 12 (end of treatment) Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12 Baseline, Weeks 1, 2, 4, 8 and 12 Change From Baseline in Waist to Hip Circumference Ratio at Week 12 Baseline and Week 12 (end of treatment)
Trial Locations
- Locations (13)
Scripps Clinical Research Center
🇺🇸La Jolla, California, United States
Radiant Research - Dallas
🇺🇸Dallas, Texas, United States
National Clinical Research - Norfolk
🇺🇸Norfolk, Virginia, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Radiant Research - Columbus
🇺🇸Columbus, Ohio, United States
Weill Cornell College
🇺🇸New York, New York, United States
Radiant Research - South Carolina
🇺🇸Anderson, South Carolina, United States
National Clinical Research - Richmond
🇺🇸Richmond, Virginia, United States
Radiant Research - Arizona
🇺🇸Chandler, Arizona, United States
Translational Research Institute for Metabolism and Diabetes
🇺🇸Orlando, Florida, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Duke University
🇺🇸Durham, North Carolina, United States