ObesityNCT03552107
Lorcaserin: Real World Experience in an Insurance-Based Weight Management Clinic
An observational study of Obesity and Weight Loss, run by Scripps Whittier Diabetes Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Overweight
- What is being tested?
- Lorcaserin
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 11 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Received at least one prescription for Lorcaserin treatment
- At least 18 years of age or with guardian/parent able to consent for a minor
Who cannot join
- Patient under the age of 18 at time of index date
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Whittier Diabetes Institute
San Diego, California, 92121
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Weight Loss, Overweight
- Being tested
- Lorcaserin
- Keywords
- Lorcaserin, Belviq
- Medical subject headings
- Obesity, Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorcaserinDrug
Also called Belviq
Treatment initiation with Lorcaserin
| Study group | Role | What they receive |
|---|---|---|
| Observational Group - Lorcaserin Treated | The group in this study will be all patients who initiated therapy with Lorcaserin during the review period. Receives: Drug: Lorcaserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change - in pounds
Change in weight with Lorcaserin treatment
Measured: Up to 1 year of medication use
Duration of Use - in weeks
Average duration of treatment with Lorcaserin
Measured: Up to 1 year of medication use
Secondary outcomes (5)
Change in heart rate
Assessment of change heart rate (bpm)
Measured: Up to 1 year of medication use
Change in blood pressure
Assessment of change in both systolic and diastolic blood pressure (mmHg)
Measured: Up to 1 year of medication use
Change in lipid levels
Assessment of change in lab values for total cholesterol, LDL, HDL and Triglycerides
Measured: Up to 1 year of medication use
Change in liver enzymes
Assessment of change in lab values for AST and ALT
Measured: Up to 1 year of medication use
Change in glucose values
Assessment of change in lab values for fasting glucose and hemoglobin A1c
Measured: Up to 1 year of medication use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start11 Apr 2017
- Primary completion11 Oct 2018
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Principal investigator, Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
- Investigators
- Ken Fujioka, MD, Principal investigator, Scripps Clinic Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552107
- Sponsor's protocol ID
- Lorcaserin
- Status last verified
- Oct 2019
- First submitted
- 17 May 2018
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Experience With Lorcaserin for Weight Management
- ClinicalTrials.gov ID
- NCT03552107
- Acronym / sponsor ID
- Lorcaserin
- Conditions
- Obesity, Weight Loss, Overweight
- Keywords
- Lorcaserin, Belviq
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group - Lorcaserin Treated | – | Drug: LorcaserinThe group in this study will be all patients who initiated therapy with Lorcaserin during the review period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Received at least one prescription for Lorcaserin treatment
- At least 18 years of age or with guardian/parent able to consent for a minor
Key exclusion criteria (1 listed)
- Patient under the age of 18 at time of index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorcaserinAlso: BelviqTreatment initiation with Lorcaserin | Drug | Observational Group - Lorcaserin Treated |
Primary outcome
Weight change - in pounds
Time frame: Up to 1 year of medication use
Change in weight with Lorcaserin treatment
Duration of Use - in weeks
Time frame: Up to 1 year of medication use
Average duration of treatment with Lorcaserin
5 secondary outcomes
Change in heart rate
Time frame: Up to 1 year of medication use
Change in blood pressure
Time frame: Up to 1 year of medication use
Change in lipid levels
Time frame: Up to 1 year of medication use
Change in liver enzymes
Time frame: Up to 1 year of medication use
Change in glucose values
Time frame: Up to 1 year of medication use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Fujioka, MD principal investigator
Scripps Clinic Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Weight Loss, run by Scripps Whittier Diabetes Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change - in pounds (time frame: Up to 1 year of medication use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.