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

March 27, 2019 updated by: Arena Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
603

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Pharmacology Research Institute
      • Escondido, California, United States, 92025
        • Synergy Escondido
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • Rancho Mirage, California, United States, 92270
        • Desert Valley Research
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Lakeland, Florida, United States, 33805
        • Meridien Research
      • Leesburg, Florida, United States, 34748
        • Compass Research East
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Oviedo, Florida, United States, 32765
        • Compass Research East
      • Tampa, Florida, United States, 33606
        • Meridien Research
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Center for Pharmaceutical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center of Nevada
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Raleigh, North Carolina, United States, 27609
        • PMG Research Inc.
      • Wilmington, North Carolina, United States, 28401
        • PMG Research Inc.
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research Inc.
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neurobehavioral Clinical Research
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Clinical Trial Center
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Lincoln Research
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Austin, Texas, United States, 78705
        • Benchmark Research
      • Dallas, Texas, United States, 75230
        • KRK Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females aged 18-65 years, inclusive
  2. ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
  3. Able to give signed informed consent

  4. Eligible female patients will be:

    1. non-pregnant
    2. non-lactating
    3. agree to use an acceptable method of effective contraception during the study
  5. Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
  6. Body weight of ≥50 kg (110 pounds), inclusive
  7. 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.

  1. Prior or current use of lorcaserin HCl
  2. Prior participation in any study of a nicotine vaccination
  3. Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
  4. Use of tobacco products other than cigarettes
  5. Prior use of fenfluramine or dexfenfluramine
  6. Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
  7. Previous participation in any clinical study within 6 weeks prior to the screening visit
  8. History of severe allergies, severe drug or excipient allergy or hypersensitivity
  9. History of significant cardiovascular condition
  10. History of other significant medical conditions
  11. Significant risk of suicide
  12. Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
  13. Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  14. Recent history of alcohol or drug/solvent abuse
  15. Concurrent participation in the study by more than one member of the same household
  16. Not suitable to participate in the study in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: APD356 10 mg b.i.d.
APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Drug: APD356-lorcaserin hydrochloride
Other Names:
  • Belviq
Experimental: APD356 10 mg q.d.
APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks
Drug: APD356-lorcaserin hydrochloride
Other Names:
  • Belviq
Placebo Comparator: Placebo 10 mg b.i.d
Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12
Time Frame: Week 9 - Week 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Abstinence During Weeks 3-12
Time Frame: Week 3 to Week 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to Week 12
Change in body weight from Week 1 (baseline) to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arena Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donald Anderson, M.D., Desert Valley Research; Rancho Mirage, California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APD356-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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