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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this protocol is to investigate, using functional magnetic resonance imaging (fMRI), the effect of treatment with lorcaserin on centers of the brain that control appetite and food intake, as well as lorcaserin's downstream metabolic effects.

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 data supports the effectiveness of the drug lorcaserin for obesity?

Research shows that lorcaserin helps people lose weight, with studies indicating a weight loss of about 3-5% more than those taking a placebo. It also helps reduce waist size, blood pressure, and cholesterol levels, making it a useful option for managing obesity. ^{1 2 3 4 5}

Is lorcaserin safe for humans?

Lorcaserin is generally well tolerated in humans, with common side effects including headache, dry mouth, constipation, dizziness, fatigue, and nausea. It has a low risk of causing heart valve problems, and its safety profile is similar to placebo in terms of serious side effects. ^{1 2 3 5 6}

How does the drug lorcaserin differ from other obesity treatments?

Lorcaserin is unique because it specifically targets the serotonin 2C receptor to help reduce appetite, which is different from other obesity drugs like orlistat that work by blocking fat absorption. It is available in an extended-release form, making it easier to take once daily, and it has shown modest weight loss results with potential improvements in blood sugar levels for people with diabetes. ^{1 2 3 6 7}

Research Team

Christos S Mantzoros, MD DSc

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetic drug evaluation of extended release lorcaserin for the treatment of obesity. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of lorcaserin in obese adults: a meta-analysis of 1-year randomized controlled trials (RCTs) and narrative review on short-term RCTs. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of lorcaserin for the treatment of obesity. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Multicentre, placebo-controlled trial of lorcaserin for weight management in Chinese population. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Lorcaserin Hcl for the treatment of obesity. [2018]

7. India pubmed.ncbi.nlm.nih.gov

Lorcaserin: A novel antiobesity drug. [2022]