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

NCT02044874 | Completed Phase 2 Results

• 1 other identifier: APD356-035
• Study Type: interventional
• Target: 603
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Abstinence During Weeks 3-12

  Week 3 to Week 12

• The 7 Day Point Prevalence or Weekly Abstinence at Week 8

  Week 8

• The 7 Day Point Prevalence or Weekly Abstinence at Week 12

  Week 12

• Body Weight

  Baseline to Week 12

Study Arms (3)

APD356 10 mg b.i.d.

EXPERIMENTAL

APD356 - lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks

Drug: APD356-lorcaserin hydrochloride

APD356 10 mg q.d.

EXPERIMENTAL

APD356 - lorcaserin hydrochloride 10 mg tablet administered once daily and one matching placebo tablet administered once daily for 12 weeks

Drug: APD356-lorcaserin hydrochloride

Placebo 10 mg b.i.d

PLACEBO COMPARATOR

Placebo tablet matching the APD356-lorcaserin hydrochloride 10 mg tablet administered twice daily for 12 weeks

Drug: Placebo

Interventions

APD356-lorcaserin hydrochloride DRUG

Also known as: Belviq

APD356 10 mg b.i.d.; APD356 10 mg q.d.

Placebo DRUG

Placebo 10 mg b.i.d

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arena Pharmaceuticals: lead

Study Sites (31)

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Synergy Escondido

Escondido, California, 92025, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Desert Valley Research

Rancho Mirage, California, 92270, United States

Location

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Meridien Research

Lakeland, Florida, 33805, United States

Location

Compass Research East

Leesburg, Florida, 34748, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Compass Research East

Oviedo, Florida, 32765, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Quality Clinical Research Inc.

Omaha, Nebraska, 68114, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

PMG Research Inc.

Raleigh, North Carolina, 27609, United States

Location

PMG Research Inc.

Wilmington, North Carolina, 28401, United States

Location

PMG Research Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Neurobehavioral Clinical Research

Canton, Ohio, 44718, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Clinical Trial Center

Jenkintown, Pennsylvania, 19046, United States

Location

Lincoln Research

Lincoln, Rhode Island, 02865, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

KRK Medical Research

Dallas, Texas, 75230, United States

Location

Related Publications (2)

• 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.

  PMID: 34611902 DERIVED

• 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.

  PMID: 27815511 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

Demonstration of sustained abstinence requires a study of \>12 weeks duration.

Results Point of Contact

• Title: Head of Document Operations
• Organization: Arena Pharmaceuticals, Inc

ct.gov@arenapharm.com

858-453-7200

Study Officials

• Donald Anderson, M.D.

  Desert Valley Research; Rancho Mirage, California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 24, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Locations

US (31)