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

NCT03552107 | Completed DMC FDA Drug

• 1 other identifier: Lorcaserin
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss; Overweight

Keywords

Lorcaserin; Belviq

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in heart rate

  Up to 1 year of medication use

• Change in blood pressure

  Up to 1 year of medication use

• Change in lipid levels

  Up to 1 year of medication use

• Change in liver enzymes

  Up to 1 year of medication use

• Change in glucose values

  Up to 1 year of medication use

Other Outcomes (2)

• Reasons for Discontinuation

  Up to 1 year of medication use

• Changes in Healthcare Utilization

  Up to 1 year of medication use

Study Arms (1)

Observational Group - Lorcaserin Treated

The group in this study will be all patients who initiated therapy with Lorcaserin during the review period.

Drug: Lorcaserin

Interventions

Lorcaserin DRUG

Treatment initiation with Lorcaserin

Also known as: Belviq

Observational Group - Lorcaserin Treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Scripps Whittier Diabetes Institute: lead
• Eisai Inc.: collaborator

Study Sites (1)

Scripps Whittier Diabetes Institute

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Overweight

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Ken Fujioka, MD

  Scripps Clinic Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Corporate Vice President

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 11, 2018
• Study Start: April 11, 2017
• Primary Completion: October 11, 2018
• Study Completion: April 11, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)