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

Obesity Clinical Trial

Official title:

Real World Experience With Lorcaserin for Weight Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552107
• Other study ID #: Lorcaserin
• Status: Completed
• Start date: April 11, 2017
• Est. completion date: April 11, 2019

Study information

• Verified date: October 2019
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: April 11, 2019
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

Drug:
• Lorcaserin
Treatment initiation with Lorcaserin

Locations

Country	Name	City	State
United States	Scripps Whittier Diabetes Institute	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Weight change - in pounds	Change in weight with Lorcaserin treatment	Up to 1 year of medication use
Primary	Duration of Use - in weeks	Average duration of treatment with Lorcaserin	Up to 1 year of medication use
Secondary	Change in heart rate	Assessment of change heart rate (bpm)	Up to 1 year of medication use
Secondary	Change in blood pressure	Assessment of change in both systolic and diastolic blood pressure (mmHg)	Up to 1 year of medication use
Secondary	Change in lipid levels	Assessment of change in lab values for total cholesterol, LDL, HDL and Triglycerides	Up to 1 year of medication use
Secondary	Change in liver enzymes	Assessment of change in lab values for AST and ALT	Up to 1 year of medication use
Secondary	Change in glucose values	Assessment of change in lab values for fasting glucose and hemoglobin A1c	Up to 1 year of medication use