A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation

Study Overview
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Brief Summary
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In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.

Official Title
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A 12-Week, Multicenter, Double-blind, Randomized, Placebo-controlled Parallel-group Phase 2 Dose Selection Study of Lorcaserin Hydrochloride, an Oral 5-HT2C Receptor Agonist for Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: APD356-lorcaserin hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 18-65 years, inclusive ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking Able to give signed informed consent Eligible female patients will be: non-pregnant non-lactating agree to use an acceptable method of effective contraception during the study Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control Body weight of ≥50 kg (110 pounds), inclusive Considered to be in stable health in the opinion of the investigator Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study. Prior or current use of lorcaserin HCl Prior participation in any study of a nicotine vaccination Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit Use of tobacco products other than cigarettes Prior use of fenfluramine or dexfenfluramine Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening Previous participation in any clinical study within 6 weeks prior to the screening visit History of severe allergies, severe drug or excipient allergy or hypersensitivity History of significant cardiovascular condition History of other significant medical conditions Significant risk of suicide Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Recent history of alcohol or drug/solvent abuse Concurrent participation in the study by more than one member of the same household Not suitable to participate in the study in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APD356 10 mg b.i.d.<br>APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks | Drug: APD356-lorcaserin hydrochloride<br> <br> * Other names: Belviq;|
| Experimental: APD356 10 mg q.d.<br>APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks | Drug: APD356-lorcaserin hydrochloride<br> <br> * Other names: Belviq;|
| Placebo Comparator: Placebo 10 mg b.i.d<br>Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 | Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm. | Week 9 - Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence During Weeks 3-12 | The CO (carbon monoxide)-confirmed continuous abstinence rate for Weeks 3 through 12, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm | Week 3 to Week 12 | 
| The 7 Day Point Prevalence or Weekly Abstinence at Week 8 | The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 8 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm | Week 8 | 
| The 7 Day Point Prevalence or Weekly Abstinence at Week 12 | The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 12 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm | Week 12 | 
| Body Weight | Change in body weight from Week 1 (baseline) to Week 12 | Baseline to Week 12 |