Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 17, 2018
First Posted Date June 11, 2018
Last Update Posted Date October 31, 2019
Actual Study Start Date April 11, 2017
Actual Primary Completion Date October 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2018)
  • Weight change - in pounds [ Time Frame: Up to 1 year of medication use ]
    Change in weight with Lorcaserin treatment
  • Duration of Use - in weeks [ Time Frame: Up to 1 year of medication use ]
    Average duration of treatment with Lorcaserin
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03552107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 29, 2018)
  • Change in heart rate [ Time Frame: Up to 1 year of medication use ]
    Assessment of change heart rate (bpm)
  • Change in blood pressure [ Time Frame: Up to 1 year of medication use ]
    Assessment of change in both systolic and diastolic blood pressure (mmHg)
  • 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
  • Change in liver enzymes [ Time Frame: Up to 1 year of medication use ]
    Assessment of change in lab values for AST and ALT
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 29, 2018)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic
Official Title Real World Experience With Lorcaserin for Weight Management
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Obesity
  • Weight Loss
  • Overweight
Intervention Drug: Lorcaserin
Treatment initiation with Lorcaserin
Other Name: Belviq
Study Groups/Cohorts Observational Group - Lorcaserin Treated
The group in this study will be all patients who initiated therapy with Lorcaserin during the review period.
Intervention: Drug: Lorcaserin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 29, 2018)
157
Original Actual Enrollment Same as current
Actual Study Completion Date April 11, 2019
Actual Primary Completion Date October 11, 2018   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03552107
Other Study ID Numbers Lorcaserin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
Study Sponsor Scripps Whittier Diabetes Institute
Collaborators Eisai Inc.
Investigators
Principal Investigator: Ken Fujioka, MD Scripps Clinic Medical Group
PRS Account Scripps Whittier Diabetes Institute
Verification Date October 2019