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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00829140
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : November 2, 2010
Information provided by:
Arena Pharmaceuticals

January 22, 2009
January 26, 2009
November 2, 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.
Same as current
Complete list of historical versions of study NCT00829140 on Archive Site
To assess the ongoing safety of lorcaserin
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
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
  • Drug: Placebo
  • Drug: Lorcaserin 10mg BID
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
  • Experimental: Lorcaserin 10mg BID
    Intervention: Drug: Lorcaserin 10mg BID

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
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