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Completed

NCT Number: NCT00829140

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

The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior participation in any study of lorcaserin.
  • Participants who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
  • Clinically significant new illness in the 1 month before screening
  • 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
  • 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.
  • Significant dislike or allergy to foods used during the food intake tests
  • 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
  • Positive result of HIV, hepatitis B or hepatitis C screens
  • 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)
  • Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening

Treatment and study plan

Placebo

Drug

Lorcaserin 10mg BID

Drug

Primary outcomes

  1. To assess the effect of lorcaserin on 24h energy metabolism (measured in a respiratory chamber) after 56 days of treatment.

Secondary outcomes

  1. To assess the ongoing safety of lorcaserin

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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)

Acronym: TULIP

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 26, 2009
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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