- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07216651
- Original Trial
WeDosify Real World Evidence (RWE) Study: Personalized Semaglutide Dosing in U.S. Adults
WeDosify Real-World Evidence: Evaluating a Clinical Decision Support and Patient Engagement Tool for Personalized Semaglutide Dosing in Adults With Overweight or Obesity in the United States
Study Overview
Status
Conditions
Detailed Description
Researchers at Amarillo Premier Research, working with Closed Loop Medicine Ltd (CLM), want to improve how excess weight and obesity are managed. There is a need for tools that support more consistent, data-informed and personalized treatment decisions in weight management. This research focuses on subjects who have recently been prescribed semaglutide (Wegovy). Semaglutide is a widely used medicine that helps patients to lose excess weight and belongs to a group of medicines called Glucagon-like peptide 1s (GLP-1s).
Only subjects who are receiving semaglutide treatment as part of their routine weight management will be invited by the study doctor to join this research study. Once consented, the study doctor will have access to a product called WeDosify, an interactive web-based Clinical Decision Support tool that assists healthcare professionals in managing adults with excess weight or obesity using GLP-1 treatment.
Participation in this study will last approximately 3 months and will include approximately 4 consultations, either study visits to the research center or remote consultations
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Amarillo, Texas, United States, 37067
- Amarillo Premier Research (an Objective Health Partnership)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants must be 18 years or older.
- Participants must have a diagnosis of either obesity or overweight.
- Participants must have initiated first-time semaglutide treatment within the past 4-12 weeks for the management of overweight or obesity, in line with United States Prescribing Information (USPI) and the clinical judgment of the responsible Healthcare Professional (HCP).
- Participants must have access to and be able to use suitable weighing scales to record their weight before or during consultations.
- Participants must provide written informed consent to participate in this study, including agreeing to adhere to the associated procedures.
Exclusion Criteria:
- Participants with conditions that the Healthcare Professional (HCP) deems would prevent effective use of weighing scales and accurate self-monitoring or reporting of body weight.
- Failure to satisfy the responsible Healthcare Professional (HCP) of fitness to participate for any other reason.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Observational semaglutide treated cohort
This research focuses on adult subjects who have recently been prescribed semaglutide (Wegovy) for obesity or overweight.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of participants who persisted on semaglutide treatment over the study period
Time Frame: 3 months
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The primary outcome is treatment persistence during the 3-month observation period, defined as the proportion of participants who remain on semaglutide treatment without discontinuation.
Discontinuation will be defined as either a formal cessation of medication or the absence of a prescription renewal within the expected timeframe
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and percentage of participants discontinuing semaglutide due to unwanted side effects or other clinically significant reasons
Time Frame: 3 months
|
Number and percentage of participants discontinuing semaglutide due to unwanted side effects or other clinically significant reasons measured as number and proportion of participants stopping semaglutide and the documented reason for discontinuation
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3 months
|
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Weight loss from baseline to end of study
Time Frame: 3 months
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Weight loss from baseline to end of study comprising weight loss magnitude and rate, assessed by absolute and percentage change in body weight
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3 months
|
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Patients' experience of WeDosify and perceived impact of treatment using custom Patient-Reported Experience Measure (PREM) and Patient-Reported Outcome Measure (PROM) questionnaires at end of study
Time Frame: 3 months
|
At the end of the study, participants will complete a brief e-questionnaire to capture their experience of the WeDosify-supported treatment journey. The questionnaire will use 5-point Likert scale and free text questions to assess:
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3 months
|
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Healthcare Professional (HCP) user experience and perceived utility assessed by custom questionnaire at end of study (to include utilization and ease of use)
Time Frame: 3 months
|
The Healthcare Professional (HCP) will complete a custom e-questionnaire at the end of the study to capture their overall experience of using the WeDosify tool. This e-questionnaire will use 5-point Likert scale and free text questions to assess:
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3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan Neese, MD, Amarillo Premier Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLM-OB-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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