← Back to Search

Serotonin Receptor Agonist

Lorcaserin for Obesity

Phase 4
Waitlist Available
Led By Christos S Mantzoros, MD DSc
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese: BMI > 30 kg/m2 or >27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis)
Women participants must use double barrier methods to prevent pregnancy (diaphragm with intravaginal spermicide, cervical cap, male or female condom with spermicide). If a woman suspects that she has become pregnant at any time or does not use one of the contraceptive methods recommended by the investigator, she must notify the study staff. If a woman becomes pregnant, she will be withdrawn from the study. The study staff will follow the progress of her pregnancy and the birth of her child.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will investigate the effect of lorcaserin on the brain's control of appetite and metabolism.

Who is the study for?
This trial is for adults with obesity (BMI > 30 or >27 with related health issues) who are not pregnant, breastfeeding, or planning pregnancy. Participants must use recommended contraception and cannot have diabetes, severe liver/renal impairment, metal implants, claustrophobia, a history of weight loss surgery, or be taking certain medications.Check my eligibility
What is being tested?
The study tests the effects of Lorcaserin HCl on brain centers controlling appetite using fMRI scans. It compares these effects to a placebo group to understand how the drug influences hunger and metabolism in obese individuals.See study design
What are the potential side effects?
Possible side effects of Lorcaserin may include headaches, dizziness, fatigue, nausea, dry mouth and constipation. There's also a risk for more serious side effects like mood changes or heart valve issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am obese with a BMI over 30, or over 27 with related health issues.
Select...
I am using two forms of birth control as required.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
fMRI (Functional changes in the brain)
Secondary outcome measures
Body Composition (DEXA)
Metabolic Rate (Resting Metabolic Rate (RMR)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Subjects will be randomized to either placebo or Lorcaserin HCl.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be randomized to either placebo or Lorcaserin HCl.

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
835 Previous Clinical Trials
13,006,490 Total Patients Enrolled
21 Trials studying Obesity
740 Patients Enrolled for Obesity
Christos S Mantzoros, MD DScPrincipal InvestigatorBeth Israel Deaconess Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for participants in this experiment?

"Per the records available on clinicaltrials.gov, this medical research is not presently recruiting participants. Initially posted on October 1st 2014, it was most recently updated on February 28th 2022. However, there are 1071 other trials actively seeking patients at this time."

Answered by AI

Does the trial accept participants over 45 years of age?

"This study is seeking patients between the ages of 18 and 65. Separately, 210 trials are available for minors under the age of consent, while 691 clinical studies exist for seniors over 65 years old."

Answered by AI

To whom does the eligibility for this clinical experiment extend?

"Eligibility requirements for this medical trial include being of age between 18 and 65, as well as displaying signs of weight loss. Approximately 40 people are needed for recruitment purposes."

Answered by AI

What other research projects have focused on the effects of Active?

"Currently, there are 3 operational trials for Active with 1 in Phase 3. Numerous of these research studies take place within Boston, Massachusetts; however, a total 43 sites scattered across the country have been established to conduct clinical trials involving Active."

Answered by AI

What is the uppermost limit of patients being included in this clinical study?

"Unfortunately, this medical trial is not currently taking applications. The study was initially posted on October 1st 2014 and last updated on February 28th 2022- if you are searching for alternative studies, 1068 trials related to weight loss and 3 associated with activity are actively recruiting participants."

Answered by AI

What perils could individuals using Active possibly encounter?

"There is ample evidence supporting the safety of Active, so it was awarded a 3 rating on our risk scale. This medication has already been approved for public use due to its extensive studies and trials."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Massachusetts
What site did they apply to?
Beth Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~4 spots leftby Mar 2025