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

Completed · Phase 4 · Has a placebo group

Conditions studied: Chronic Weight Management

In brief

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.

Key facts

Study ID

NCT01987427

Run by

Eisai Inc.

People needed

344

Starts

2013-10-30

Expected to finish

2014-09-03

Last updated by the study team

2019-09-30

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI is 30 kg/m2 or greater with or without a weight-related comorbid condition (e.g., hypertension, dyslipidemia, sleep apnea), or 27 to 29.9 kg/m2 with at least one weight-related comorbid condition.
• Ambulatory and able to perform moderate exercise.
• Male or female subjects between 18 and 60 years at the time of informed consent.
• Provide written informed consent.
• Willing and able to comply with all aspects of the protocol.

You may not qualify if…

• Recent treatment (within 14 days of the Screening Visit and any time prior to randomization) with monoamine oxidase inhibitors (MAOIs). MAOIs have been associated with a risk of hypertensive crisis when used with phentermine.
• Active or recent history (within 1 month prior to the Screening Visit) of major depression or other major psychiatric disease requiring treatment (i.e., within 1 month of the Screening Visit and any time prior to randomization or thereafter during the study) with prescription medication (e.g., SSRIs, SNRIs, tricyclics, antipsychotics, lithium, Wellbutrin).
• Use of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) (including buproprion) for reasons other than active psychiatric indications (e.g., migraine, weight loss, smoking cessation) within 1 month prior to the Screening Visit).
• Medication history that includes use of one or more of the following:
• Fenfluramine or related derivatives (i.e., dexfenfluramine, norfenfluramine)
• Agents that have documented correlation with increased incidence of valvulopathy and/or primary pulmonary hypertension (e.g., cabergoline, cyproheptadine, trazodone, nefazodone, amoxapine, mirtazapine, pergolide, ergotamine, methysergide)
• Recent treatment (i.e., within 1 month of the Screening Visit and any time prior to randomization or thereafter during the study) with over-the-counter (OTC) weight loss products or appetite suppressants (including herbal weight loss agents), or within 6 months and any time prior to randomization or thereafter during the study, with a prescription weight loss drug (e.g., phentermine, phentermine/topiramate, orlistat).
• Use of St. John's Wort within 1 month prior to the Screening Visit and for the duration of the study. St. John's Wort has been associated with serotonin syndrome when used with another serotonergic drug.
• Hypersensitivity to sympathomimetic amines or the study drugs.
• History of stroke, transient ischemic attack, arrhythmias, congestive heart failure, and/or peripheral vascular disease.
• Recent history of active cardiovascular disease, including chronic stable angina or an unstable angina episode or myocardial infarction within the 3 months prior to the Screening Visit.
• Uncontrolled hypertension defined as systolic blood pressure greater than or equal to 150 or diastolic blood pressure greater than or equal to 95 on 2 readings taken on different days. Subjects who have uncontrolled hypertension at screening may be re-screened greater than 1 month following initiation or adjustment of antihypertensive therapy.
• History of or active pulmonary artery hypertension.
• Severe renal impairment (creatinine clearance less than 30 mL/min, as calculated by the Cockroft-Gault equation based on ideal body weight) or end stage renal disease.
• History of valve replacement surgery; clinically significant valvular stenosis; history of or active clinically significant valvulopathy (defined as aortic insufficiency of mild, moderate, or severe intensity and/or mitral insufficiency of moderate or severe intensity).
• History of or active (confirmed fasting glucose greater than 126 mg/dL or hemoglobin A1c [HbA1c] greater than ULN [6.5% at central laboratory]) diabetes mellitus (type I, II or other) and/or currently taking medications for type I or II diabetes. A past history of gestational diabetes that has resolved is permissible.
• Glaucoma.
• Abnormal thyroid stimulating hormone (TSH) laboratory value greater than 1.5 x Upper Limit of Normal (ULN)
• Hyperthyroidism, including abnormal screening laboratory values with T3 greater than ULN and TSH less than Lower Limit of Normal (LLN), and subjects taking methimazole or propylthiouracil (PTU) and/or beta-blockers for hyperthyroidism.
• Recent history (within 2 years prior to the Screening Visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
• Significant change is smoking habits or tobacco product use within 3 months prior to the Screening Visit.
• Use of tobacco products (i.e., smokes more than one-half pack of cigarettes per day, or smokes more than 2 cigars per day, or uses 3 or more pinches of smokeless tobacco per day).
• Surgical procedure for the treatment of obesity (i.e., gastric bypass, gastric banding), even if reversed prior to screening.
• Planned surgery during the study period that may interfere with completion or compliance with the protocol.
• A prolonged QT/QTc interval (QTc Bazett's greater than 450 msec) as demonstrated by a repeated electrocardiogram (ECG).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Radiant Research - Arizona — Chandler, Arizona, United States
• Scripps Clinical Research Center — La Jolla, California, United States
• Translational Research Institute for Metabolism and Diabetes — Orlando, Florida, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Weill Cornell College — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Radiant Research - Columbus — Columbus, Ohio, United States
• Radiant Research - South Carolina — Anderson, South Carolina, United States
• Radiant Research - Dallas — Dallas, Texas, United States
• National Clinical Research - Norfolk — Norfolk, Virginia, United States
• National Clinical Research - Richmond — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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