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

Completed

• Conditions: Obesity; Weight Loss; Overweight
• Interventions: Drug: Lorcaserin

• Registration Number: NCT03552107
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-04-11
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-11
• Primary Completion: 2018-10-11
• Study Completion: 2019-04-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Group - Lorcaserin Treated	Lorcaserin	The group in this study will be all patients who initiated therapy with Lorcaserin during the review period.

Primary Outcome Measures

Name	Time	Method
Duration of Use - in weeks	Up to 1 year of medication use	Average duration of treatment with Lorcaserin
Weight change - in pounds	Up to 1 year of medication use	Change in weight with Lorcaserin treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Scripps Whittier Diabetes Institute; 🇺🇸 San Diego, California, United States