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To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake (TULIP)

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00829140
First received: January 22, 2009
Last updated: November 1, 2010
Last verified: November 2010
History of Changes

January 22, 2009
November 1, 2010
November 2008
September 2009   (final data collection date for primary outcome measure)
To assess the effect of lorcaserin on 24h energy metabolism (measured in a respiratory chamber) after 56 days of treatment. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00829140 on ClinicalTrials.gov Archive Site
To assess the ongoing safety of lorcaserin [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake
A 56-Day , Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake in Overweight and Obese Patients (TULIP)

The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Obesity
  • Drug: Placebo
  • Drug: Lorcaserin 10mg BID
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
  • Experimental: Lorcaserin 10mg BID
    Intervention: Drug: Lorcaserin 10mg BID
Martin CK, Redman LM, Zhang J, Sanchez M, Anderson CM, Smith SR, Ravussin E. Lorcaserin, a 5-HT(2C) receptor agonist, reduces body weight by decreasing energy intake without influencing energy expenditure. J Clin Endocrinol Metab. 2011 Mar;96(3):837-45. Epub 2010 Dec 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
February 2010
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males or females aged between 18 and 65 years (inclusive)
  2. Body Mass Index (BMI) is 27.0 to 45.0 kg/m2, inclusive
  3. Able to give signed informed consent
  4. Ambulatory and able to perform exercise program (Arena Healthy Lifestyle Program, see Appendix 1)
  5. Eligible male and female patients must agree not to participate in a conception process
  6. Considered to be in stable health in the opinion of the Investigator

Exclusion Criteria:

  1. Prior participation in any study of lorcaserin.
  2. Participants who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
  3. Clinically significant new illness in the 1 month before screening
  4. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
  5. Recent history (within 6 months before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication. SSRI's, SNRI's, and other medications must meet washout requirements.
  6. Significant dislike or allergy to foods used during the food intake tests

  7. History of any of the following cardiovascular conditions:

    • Myocardial infarction (diagnosed by cardiac enzyme[s] and/or diagnostic ECG), CVA, TIA or RIND within 3 months of screening; cardiac arrhythmia requiring medical or surgical treatment within 3 months of screening
    • Unstable angina
    • History of congestive heart failure caused by insufficiency, damage, or stenosis of any heart valve
    • History of pulmonary artery hypertension
  8. Positive result of HIV, hepatitis B or hepatitis C screens
  9. Recent treatment (i.e., within 1 month of the screening visit) with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents), or within 3 months with a prescription anti-obesity drug (e.g., phentermine, sibutramine, orlistat)
  10. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829140
APD356-014
No
Christen Anderson MD, PhD, Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals
Not Provided
Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center
Arena Pharmaceuticals
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP