Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-09 @ 8:36 AM
Study NCT ID:
NCT01987427
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2013-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief 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
Sponsor:
Eisai Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: