Chronic Weight Management Clinical Trial
Official title:
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
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.
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.
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