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Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic

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ClinicalTrials.gov Identifier: NCT03552107
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute

Brief Summary:
This is a retrospective, descriptive study that involves de-identified data consisting of weight changes, pertinent vital signs and laboratory values influenced by body weight, and healthcare utilization of patients prescribed lorcaserin at The Center for Weight Management at the Scripps Clinic in San Diego, CA.

Condition or disease Intervention/treatment
Obesity Weight Loss Overweight Drug: Lorcaserin

Detailed Description:
All patients who initiated treatment with Lorcaserin during the review period will undergo chart review. The primary endpoint will be weight change in patients on Lorcaserin and average duration of Lorcaserin treatment over time (up to 1 year). Secondary endpoints will include changes in vital signs, liver function, glucose, and lipids. In addition, time on treatment, reasons for discontinuation of medication, and changes in healthcare utilization (to include inpatient and outpatient utilization) will be examined. This is a retrospective, one-arm observational study that will include chart reviews of 157 patients who have been treated in the clinic.

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Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Real World Experience With Lorcaserin for Weight Management
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : October 11, 2018
Actual Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Lorcaserin

Group/Cohort Intervention/treatment
Observational Group - Lorcaserin Treated
The group in this study will be all patients who initiated therapy with Lorcaserin during the review period.
Drug: Lorcaserin
Treatment initiation with Lorcaserin
Other Name: Belviq




Primary Outcome Measures :
  1. Weight change - in pounds [ Time Frame: Up to 1 year of medication use ]
    Change in weight with Lorcaserin treatment

  2. Duration of Use - in weeks [ Time Frame: Up to 1 year of medication use ]
    Average duration of treatment with Lorcaserin


Secondary Outcome Measures :
  1. Change in heart rate [ Time Frame: Up to 1 year of medication use ]
    Assessment of change heart rate (bpm)

  2. Change in blood pressure [ Time Frame: Up to 1 year of medication use ]
    Assessment of change in both systolic and diastolic blood pressure (mmHg)

  3. Change in lipid levels [ Time Frame: Up to 1 year of medication use ]
    Assessment of change in lab values for total cholesterol, LDL, HDL and Triglycerides

  4. Change in liver enzymes [ Time Frame: Up to 1 year of medication use ]
    Assessment of change in lab values for AST and ALT

  5. Change in glucose values [ Time Frame: Up to 1 year of medication use ]
    Assessment of change in lab values for fasting glucose and hemoglobin A1c


Other Outcome Measures:
  1. Reasons for Discontinuation [ Time Frame: Up to 1 year of medication use ]
    Reasons for discontinuing treatment with Lorcaserin - as obtained by annotation in patient's medical record from overseeing physician.

  2. Changes in Healthcare Utilization [ Time Frame: Up to 1 year of medication use ]
    Assessment of changes in healthcare utilization including all Scripps outpatient medical visits, visits to the ER and/or Urgent care, and inpatient hospitalizations. All of the above are assessed via the Scripps network EMR and only include visits made to a Scripps facility. Reason for visit and level of visit billed reviewed via EMR using billing and diagnosis codes.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population includes 157 patients seen and evaluated in an insurance-based medical weight loss clinic in San Diego, CA. Eligible participants will include patients who are overweight or obese, and who received at least one prescription for Lorcaserin treatment.
Criteria

Inclusion Criteria:

  • Received at least one prescription for Lorcaserin treatment
  • At least 18 years of age or with guardian/parent able to consent for a minor

Exclusion Criteria:

- Patient under the age of 18 at time of index date


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552107


Locations
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United States, California
Scripps Whittier Diabetes Institute
San Diego, California, United States, 92121
Sponsors and Collaborators
Scripps Whittier Diabetes Institute
Eisai Inc.
Investigators
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Principal Investigator: Ken Fujioka, MD Scripps Clinic Medical Group

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Responsible Party: Athena Philis-Tsimikas, Corporate Vice President, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier: NCT03552107     History of Changes
Other Study ID Numbers: Lorcaserin
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute:
Lorcaserin
Belviq
Additional relevant MeSH terms:
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Body Weight
Overweight
Weight Loss
Signs and Symptoms
Body Weight Changes