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
Condition: Chronic Weight Management
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): lorcaserin + phentermine placebo; lorcaserin + phentermine-HCl + phentermine placebo; lorcaserin + phentermine-HCl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): lorcaserin 10 mg BID + phentermine placebo BID; lorcaserin 10 mg BID + phentermine-HCl 15 mg QD + phentermine placebo QD; lorcaserin 10 mg BID + phentermine-HCl 15 mg BID
Intervention MeSH terms: Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Overweight; Obese; Weight Management