Lorcaserin for Obesity

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Weight loss drugs, Antidepressants, Steroids, others

Disqualifiers: Diabetes, Renal impairment, Hepatic impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how lorcaserin, a medication, affects the brain's control over hunger and its impact on metabolism. Researchers use brain imaging to better understand these effects. Participants will receive either lorcaserin or a placebo (a substance with no active medication) to compare results. The trial seeks individuals with obesity, defined as a BMI over 30, or a BMI over 27 with certain health issues like high blood pressure or sleep apnea. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using any weight loss products and certain other medications like serotonergic medications, phosphodiesterase inhibitors, and others listed in the exclusion criteria. If you are on hormonal contraceptives, you must stay on the same medication and dose throughout the study.

What is the safety track record for Lorcaserin HCl?

Research has shown that lorcaserin is generally safe for weight loss. In earlier studies, participants taking lorcaserin lost more weight than those taking a placebo, a pill with no active ingredients. However, some safety concerns exist. Specifically, one study found that about 6.1% of participants taking lorcaserin experienced major heart-related issues. This indicates that a small number of individuals encountered heart problems.

Additionally, there is a possible increased risk of cancer linked to lorcaserin. This consideration is important for those thinking about joining a trial. While the treatment can aid in weight loss, its potential side effects require careful consideration. Consulting a healthcare provider before making a decision is essential. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Lorcaserin is unique because it targets serotonin receptors in the brain to reduce appetite, offering a distinct approach compared to many current obesity treatments that focus on calorie restriction or increasing metabolism. This mechanism can help individuals manage their weight by curbing hunger more effectively. Researchers are excited about Lorcaserin because it has shown promise in promoting significant weight loss with a favorable safety profile, which can be a game-changer for individuals struggling with obesity.

What is the effectiveness track record for lorcaserin in treating obesity?

Research has shown that lorcaserin, which participants in this trial may receive, can aid in weight loss. In one study, participants taking lorcaserin lost an average of 5.81% of their body weight, while those on a placebo lost only 2.16%. Another study found that after one year, lorcaserin led to significant weight loss in overweight adults. Additionally, lorcaserin improved blood sugar levels and lowered blood pressure. Overall, lorcaserin has proven effective for weight loss and offers additional health benefits. ^{1 3 6 7 8}

Who Is on the Research Team?

Christos S Mantzoros, MD DSc

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am obese with a BMI over 30, or over 27 with related health issues.

I am using two forms of birth control as required.

Exclusion Criteria

Hypersensitivity to the active substance or any of the excipients in lorcaserin

Women using IUD (intrauterine device)

Body weight above the limitation of the MRI scanning table (330lbs/150 Kg) or body dimensions that could difficult the performance of the scan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lorcaserin or placebo to investigate its effects on brain centers controlling appetite and food intake using fMRI

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lorcaserin HCl
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Active Active Control 1 Intervention

Subjects will be randomized to either placebo or Lorcaserin HCl.

Group II: Placebo Placebo Group 1 Intervention

Subjects will be randomized to either placebo or Lorcaserin HCl.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

Oral lorcaserin is effective for weight management in obese and overweight adults, showing significant weight loss compared to placebo in three large studies over 12 months, with many participants achieving a ≥5% or ≥10% reduction in body weight.

Lorcaserin is generally well tolerated, with low rates of serious side effects like valvulopathy, and those who maintained weight loss after 12 months continued to do so better than those who switched to placebo, indicating its potential for long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lorcaserin: a review of its use in chronic weight management. Hoy, SM.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36477550/

Effectiveness and persistence of anti-obesity medications ... Lorcaserin had only a modest effect on weight loss, with an average weight loss of 1.7 kg at 6 months. Orlistat had almost no impact on weight ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1808721

Cardiovascular Safety of Lorcaserin in Overweight or ... The primary efficacy outcome of extended major cardiovascular events occurred in 707 patients (11.8%, or 4.1% per year) in the lorcaserin group ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3828930/

Lorcaserin (Belviq): A Selective Serotonin 5-HT2C Agonist In ... Patients in the lorcaserin group lost an average 5.81% of their baseline body weight compared with 2.16% in the placebo group (P < 0.001). The results were ...

4. academic.oup.com academic.oup.com/jcem/article/96/10/3067/2834879

One-Year Randomized Trial of Lorcaserin for Weight Loss in ... Lorcaserin used for up to 1 yr was associated with significant weight loss among obese and overweight adults. This study contributes to the overall ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.038341

Lorcaserin and Renal Outcomes in Obese and Overweight ... The efficacy of lorcaserin in improving weight, hemoglobin A1c, and systolic blood pressure is consistent regardless of baseline renal function.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30145941/

Cardiovascular Safety of Lorcaserin in Overweight or ... Results: At 1 year, weight loss of at least 5% had occurred in 1986 of 5135 patients (38.7%) in the lorcaserin group and in 883 of 5083 (17.4%) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02019264

NCT02019264 | A Study to Evaluate the Effect of Long-term ... A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to ...

8. fda.gov fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr

Safety clinical trial shows possible increased risk of cancer ... Results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).