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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829140
First Posted: January 26, 2009
Last Update Posted: November 2, 2010
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.
Information provided by:
Arena Pharmaceuticals
  Purpose
The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.

Condition Intervention Phase
Obesity Drug: Placebo Drug: Lorcaserin 10mg BID Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • To assess the effect of lorcaserin on 24h energy metabolism (measured in a respiratory chamber) after 56 days of treatment.

Secondary Outcome Measures:
  • To assess the ongoing safety of lorcaserin

Estimated Enrollment: 56
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo BID Drug: Placebo
Experimental: Lorcaserin 10mg BID Drug: Lorcaserin 10mg BID

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829140


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center