Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT07216651
Status:
RECRUITING
Last Update Posted:
2025-10-17
First Post:
2025-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
WeDosify Real World Evidence (RWE) Study: Personalized Semaglutide Dosing in U.S. Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2025-10-10', 'studyFirstSubmitQcDate': '2025-10-10', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who persisted on semaglutide treatment over the study period', 'timeFrame': '3 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Number and percentage of participants discontinuing semaglutide due to unwanted side effects or other clinically significant reasons', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Weight loss from baseline to end of study', 'timeFrame': '3 months', 'description': 'Weight loss from baseline to end of study comprising weight loss magnitude and rate, assessed by absolute and percentage change in body weight'}, {'measure': "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", 'timeFrame': '3 months', 'description': 'At the end of the study, participants will complete a brief e-questionnaire to capture their experience of the WeDosify-supported treatment journey.\n\nThe questionnaire will use 5-point Likert scale and free text questions to assess:\n\n* Patient-Reported Outcome Measures (PROMs): to assess the perceived impact of WeDosify on weight and overall health.\n* Patient-Reported Experience Measures (PREMs): to capture satisfaction with WeDosify, including engagement with treatment, clarity of the treatment plan, and motivation to complete it.'}, {'measure': 'Healthcare Professional (HCP) user experience and perceived utility assessed by custom questionnaire at end of study (to include utilization and ease of use)', 'timeFrame': '3 months', 'description': '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.\n\nThis e-questionnaire will use 5-point Likert scale and free text questions to assess:\n\n* Usability and ease of use\n* Perceived value of the treatment options\n* HCP insights on clinical use and potential improvements'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Overweight', 'GLP-1', 'Semaglutide'], 'conditions': ['Obesity & Overweight']}, 'descriptionModule': {'briefSummary': 'This research study is studying WeDosify, an interactive web-based Clinical Decision Support tool that assists healthcare professionals in managing adults with excess weight or obesity using a Glucagon-like peptide-1 (GLP-1) drug treatment such as semaglutide.', 'detailedDescription': '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).\n\nOnly 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.\n\nParticipation in this study will last approximately 3 months and will include approximately 4 consultations, either study visits to the research center or remote consultations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with Obesity or Overweight receiving semaglutide (Wegovy)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must be 18 years or older.\n2. Participants must have a diagnosis of either obesity or overweight.\n3. 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).\n4. Participants must have access to and be able to use suitable weighing scales to record their weight before or during consultations.\n5. Participants must provide written informed consent to participate in this study, including agreeing to adhere to the associated procedures.\n\nExclusion Criteria:\n\n1. 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.\n2. Failure to satisfy the responsible Healthcare Professional (HCP) of fitness to participate for any other reason.'}, 'identificationModule': {'nctId': 'NCT07216651', 'briefTitle': 'WeDosify Real World Evidence (RWE) Study: Personalized Semaglutide Dosing in U.S. Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Closed Loop Medicine'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CLM-OB-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational semaglutide treated cohort', 'description': 'This research focuses on adult subjects who have recently been prescribed semaglutide (Wegovy) for obesity or overweight.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37067', 'city': 'Amarillo', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Administrator', 'role': 'CONTACT', 'email': 'studies@objective.health', 'phone': '855-460-8031'}, {'name': 'Susan Neese, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amarillo Premier Research (an Objective Health Partnership)', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}], 'centralContacts': [{'name': 'Susan Neese, MD', 'role': 'CONTACT', 'email': 'studies@objective.health', 'phone': '855-460-8031'}], 'overallOfficials': [{'name': 'Susan Neese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amarillo Premier Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Closed Loop Medicine', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}