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Serotonin Receptor Agonist

Lorcaserin for Weight Loss in Patients on Antipsychotics

Phase 4

Waitlist Available

Research Sponsored by Southern California Institute for Research and Education

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient's BMI is greater than or equal to 30 kg/m2 OR the patient's BMI is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis.

Patients currently on atypical antipsychotics

Must not have

The patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation

Age less than 18 or greater than 65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test whether the drug lorcaserin can help people with weight gain from antipsychotic medications lose weight.

Who is the study for?

This trial is for adults aged 18-65 who gained weight from antipsychotic meds, with a BMI ≥30 or ≥27 with conditions like hypertension. They must commit to follow-up visits and not be on other weight loss drugs, have severe heart valve issues, recent drug abuse, suicidal thoughts, dementia, or be pregnant/breastfeeding.

What is being tested?

The study tests if lorcaserin helps patients on antipsychotics lose weight. It includes intensive dietary counseling and regular check-ins over 16 weeks to monitor progress and effectiveness of the medication in reducing body weight.

What are the potential side effects?

Lorcaserin may cause headaches, dizziness, fatigue, nausea, dry mouth or constipation. Serious side effects could include heart-related issues due to its action on serotonin receptors but are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is 30 or higher, or it's 27 or higher with a weight-related health issue.

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I am currently taking medication for mental health that is not a typical antipsychotic.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe leakage in my heart valves.

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I am either younger than 18 or older than 65.

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I am currently taking medication for weight loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight loss

Secondary study objectives

Evaluation of blood count

Evaluation of cholesterol control

Evaluation of cravings

+4 more

Side effects data

From 2018 Phase 2 trial • 97 Patients • NCT02906644

36%

Vivid Dreams

23%

Itching at Patch Site

21%

Fatigue

13%

Dry Mouth

Coughing

Constipation

Rash at Patch Site

Insomnia

Dizziness/Lightheadedness

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Lorcaserin + Patch

Patch (1st 2 Weeks)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lorcaserin with intensive diet counselingExperimental Treatment2 Interventions

Patients will be taking lorcaserin 10mg tablet by mouth twice daily. In addition, patients will be provided with intensive dietary counseling to promote weight loss.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lorcaserin

FDA approved

0 / 5Eligibility criteria met