Conditions: Chronic Weight Management
Keywords: Overweight Obese Weight Management
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 344
Healthy volunteers: no

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.

Arms:
arm 1: lorcaserin + phentermine placebo arm 2: lorcaserin + phentermine-HCl + phentermine placebo arm 3: lorcaserin + phentermine-HCl

Interventions: intervention 1: lorcaserin + phentermine placebo intervention 2: lorcaserin + phentermine-HCl + phentermine placebo intervention 3: lorcaserin + phentermine-HCl
Intervention descriptions: intervention 1: lorcaserin 10 mg BID + phentermine placebo BID intervention 2: lorcaserin 10 mg BID + phentermine-HCl 15 mg QD + phentermine placebo QD intervention 3: lorcaserin 10 mg BID + phentermine-HCl 15 mg BID

Protocol document: