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To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake (TULIP)
This study is currently recruiting participants.
Verified by Arena Pharmaceuticals, January 2009
First Received: January 22, 2009   Last Updated: January 23, 2009   History of Changes
Sponsored by: Arena Pharmaceuticals
Information provided by: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00829140
  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 I

MedlinePlus related topics: Obesity
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
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)

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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the ongoing safety of lorcaserin [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829140

Contacts
Contact: Scott C Stubbe 858-453-7200 ext 1602 sstubbe@arenapharm.com
Contact: Marianne Mancini 858-453-7200 ext 1678 mmancini@arenapharm.com

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Eric Ravussin, PhD     225-763-3186     Eric.Ravussin@pbrc.edu    
Contact: Steven R Smith, MD     225.763.3028     SmithSR@pbrc.edu    
Principal Investigator: Eric Ravussin, PhD            
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Arena Pharmaceuticals, Inc. ( Christen Anderson MD, PhD )
Study ID Numbers: APD356-014
Study First Received: January 22, 2009
Last Updated: January 23, 2009
ClinicalTrials.gov Identifier: NCT00829140     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009