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

September 11, 2019 updated by: Eisai Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
To assess the ongoing safety of lorcaserin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

November 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • APD356-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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