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

Real World Experience With Lorcaserin for Weight Management

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 157

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Scripps Whittier Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Belviq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change - in pounds	Change in weight with Lorcaserin treatment	Up to 1 year of medication use
Duration of Use - in weeks	Average duration of treatment with Lorcaserin	Up to 1 year of medication use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Assessment of change heart rate (bpm)	Up to 1 year of medication use
Change in blood pressure	Assessment of change in both systolic and diastolic blood pressure (mmHg)	Up to 1 year of medication use
Change in lipid levels	Assessment of change in lab values for total cholesterol, LDL, HDL and Triglycerides	Up to 1 year of medication use
Change in liver enzymes	Assessment of change in lab values for AST and ALT	Up to 1 year of medication use
Change in glucose values	Assessment of change in lab values for fasting glucose and hemoglobin A1c	Up to 1 year of medication use

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for Discontinuation	Reasons for discontinuing treatment with Lorcaserin - as obtained by annotation in patient's medical record from overseeing physician.	Up to 1 year of medication use
Changes in Healthcare Utilization	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.	Up to 1 year of medication use

Collaborators and Investigators

• Sponsor: Scripps Whittier Diabetes Institute
• Collaborators: Eisai Inc.
• Investigators: Principal Investigator: Ken Fujioka, MD, Scripps Clinic Medical Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2017
• Primary Completion (ACTUAL): October 11, 2018
• Study Completion (ACTUAL): April 11, 2019

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (ACTUAL): June 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Lorcaserin; Belviq
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: Lorcaserin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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