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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 If a woman becomes pregnant, she will be withdrawn from the study.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.
Must not have
Moderate, or severe hepatic impairment
Alcohol consumption- the maximum quantity for men is 140g-210g per week. For women, the range is 84g-140g per week or drinking as consuming no more than two drinks a day for men and one for women. Alcohol can cause increased risk of pancreatitis and hypoglycemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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
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I am obese with a BMI over 30, or over 27 with related health issues.
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I am using two forms of birth control as required.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver is not working well.
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I drink no more than two drinks a day if I'm a man, or one if I'm a woman.
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I have been diagnosed with diabetes based on my blood sugar levels.
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I have untreated thyroid disease.
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I have not changed my hormonal birth control dose or type recently.
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I have congestive heart failure or pulmonary hypertension.
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I have a heart rhythm problem or heart valve disease.
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I have a condition like inflammatory bowel disease or rheumatoid arthritis.
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I am currently taking medications like antidepressants, blood thinners, steroids, or hormone treatments.
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I do not have uncontrolled heart or circulation problems, nor issues with sweating.
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I have major issues with feeling or moving parts of my body.
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I do not have any uncontrolled infectious diseases like HIV or hepatitis.
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I do not have any uncontrolled hormone disorders like Cushing's or Acromegaly.
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I have been diagnosed with cancer or lymphoma.
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I have an eating disorder such as anorexia or bulimia.
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I have had weight loss surgery or part of my stomach removed.
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I am pregnant, breastfeeding, or planning to become pregnant.
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My kidney function is significantly reduced.
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I haven't used any weight loss drugs in the last 3 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Body Composition (DEXA)
Metabolic Rate (Resting Metabolic Rate (RMR)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
855 Previous Clinical Trials
12,930,921 Total Patients Enrolled
21 Trials studying Obesity
740 Patients Enrolled for Obesity
Christos S Mantzoros, MD DScPrincipal InvestigatorBeth Israel Deaconess Medical Center
~0 spots leftby Dec 2024
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