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

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00829140
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Placebo; Drug: Lorcaserin 10mg BID	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• 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)
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo BID	Drug: Placebo
Experimental: Lorcaserin 10mg BID	Drug: Lorcaserin 10mg BID

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. To assess the ongoing safety of lorcaserin []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Positive result of HIV, hepatitis B or hepatitis C screens

2. 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)

3. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Eisai Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT00829140
• Other Study ID Numbers: APD356-014
• First Posted: Jan 26, 2009
• Last Update Posted: Sep 12, 2019
• Last Verified: Nov 1, 2010

Study Results

No Results Posted as of Sep 12, 2019