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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

NCT00828724

Obesity

COMPLETED PHASE1

A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

NCT04081337

Obesity

COMPLETED PHASE1

A Study of Tirzepatide in Overweight and Very Overweight Participants

NCT04311411

Obesity Overweight

COMPLETED PHASE1

Lifestyle Modification and Lorcaserin for Weight Loss Maintenance

NCT02388568

Obesity

COMPLETED NA

Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients

NCT03720574

Obesity

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Lorcaserin 10mg BID

Group Type EXPERIMENTAL

Lorcaserin 10mg BID

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Intervention Type DRUG

Lorcaserin 10mg BID

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No