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Completed

NCT Number: NCT03552107

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Whittier Diabetes Institute

San Diego, California, 92121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorcaserin

Drug

Treatment initiation with Lorcaserin

Other names: Belviq

Primary outcomes

  1. Weight change - in pounds

    Time frame: Up to 1 year of medication use

    Change in weight with Lorcaserin treatment

  2. Duration of Use - in weeks

    Time frame: Up to 1 year of medication use

    Average duration of treatment with Lorcaserin

Secondary outcomes

  1. Change in heart rate

    Time frame: Up to 1 year of medication use

    Assessment of change heart rate (bpm)

  2. Change in blood pressure

    Time frame: Up to 1 year of medication use

    Assessment of change in both systolic and diastolic blood pressure (mmHg)

  3. 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

  4. Change in liver enzymes

    Time frame: Up to 1 year of medication use

    Assessment of change in lab values for AST and ALT

  5. 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

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Scripps Whittier Diabetes Institute

Other

Collaborators

  • Eisai Inc.

Registry information

Official study title

Real World Experience With Lorcaserin for Weight Management

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 11, 2018
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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