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

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: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Placebo; Drug: APD356-lorcaserin hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 603
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Arena Pharmaceuticals
• Investigators: Principal Investigator: Donald Anderson, M.D., Desert Valley Research; Rancho Mirage, California

Publications and helpful links

General Publications

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
• Shanahan WR, Rose JE, Glicklich A, Stubbe S, Sanchez-Kam M. Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial. Nicotine Tob Res. 2017 Aug 1;19(8):944-951. doi: 10.1093/ntr/ntw301.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 24, 2014

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: APD356-035