Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT07092605
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-30
First Post:
2024-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'C000591245', 'term': 'semaglutide'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-28', 'size': 1267759, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-18T09:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-Center, Prospective, Blinded, Randomised, Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in self-reported pain levels in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'Participants will complete an extensive medical questionnaire every 4 weeks over a 24-week period to monitor self-reported pain levels'}, {'measure': 'Concentration of complete blood cells, as a measure of immunological health, in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'CBC panel will be analyzed every 12 weeks over a 24-week period, reported in thousands of cells per microliter with the change from baseline reported as percent deviation and compared to normalized range of healthy individuals'}, {'measure': 'Concentration of basic metabolites (cholesterol, glucose, creatinine, sodium, potassium), as a measure of immunological health, in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'BMP panel will be analyzed every 12 weeks over a 24-week period, reported in mg/dL with the change from baseline reported as percent deviation and compared to a normalized range of healthy individuals'}, {'measure': 'Change in mood in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'Mood will be assessed every 4 weeks over a 24-week period using the SF-36 standardized questionnaire with deviation reported as percent change from baseline'}, {'measure': 'Change in heart rate variability in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': "Participants will wear health devices with data monitored every 4 weeks over a 24-week period to observe change in heart rate variability, being defined as the variability of a participant's resting heart rate. Variability will be measured as an average deviation from baseline heart rate at each timepoint and reported as percent difference."}, {'measure': 'Changes in sleep patterns in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'Wearable health device data will be monitored over the 24-week period assessing REM vs non-REM sleep and reported as a ratio'}, {'measure': 'Change in frequency of physical activity in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'The change in frequency of physical activity, defined as a departure from baseline in time spent performing moderate to rigorous physical exercise, will be captured via wearable health device data and will be reported as percent difference from baseline in steps taken.'}, {'measure': 'Change in frequency of physical activity in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'The change in frequency of physical activity, defined as a departure from baseline in time spent performing moderate to rigorous physical exercise, will be captured via wearable health device data and will be reported as percent difference from baseline in calories burned.'}], 'secondaryOutcomes': [{'measure': 'Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'Changes in HbA1c levels will be assessed every 12 weeks and reported as a percent deviation from baseline'}, {'measure': 'Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'Changes in LDL cholesterol levels will be assessed every 12 weeks and reported as a percent deviation from baseline'}, {'measure': 'Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'Changes in HDL cholesterol levels will be assessed every 12 weeks and reported as a percent deviation from baseline'}, {'measure': 'Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s', 'timeFrame': '6 months', 'description': 'Changes in triglyceride levels will be assessed every 12 weeks and reported as a percent deviation from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microdosing GLP1s', 'Longevity', 'Weight Management', 'Quality of Life'], 'conditions': ['Longevity', 'Quality of Life', 'Mood', 'Inflammation', 'Immune Health', 'Pain Management', 'Weight Management', 'Alertness']}, 'referencesModule': {'references': [{'pmid': '31680842', 'type': 'BACKGROUND', 'citation': "Grieco M, Giorgi A, Gentile MC, d'Erme M, Morano S, Maras B, Filardi T. Glucagon-Like Peptide-1: A Focus on Neurodegenerative Diseases. Front Neurosci. 2019 Oct 18;13:1112. doi: 10.3389/fnins.2019.01112. eCollection 2019."}, {'pmid': '27633186', 'type': 'BACKGROUND', 'citation': 'Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.'}, {'pmid': '29617641', 'type': 'BACKGROUND', 'citation': 'Drucker DJ. Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1. Cell Metab. 2018 Apr 3;27(4):740-756. doi: 10.1016/j.cmet.2018.03.001.'}], 'seeAlsoLinks': [{'url': 'https://agelessrx.com/research/', 'label': 'Link to AgelessRx Research page.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study has two objectives. The Primary Objective is to evaluate the effectiveness of microdosed GLP-1 receptor agonists in improving measures of health, quality of life, and longevity. The Secondary Objective: To assess the impact of these therapies on weight management practices and metabolic health.', 'detailedDescription': 'Participants will be assigned to one of three groups: 1) control, 2) microdosed sublingual semaglutide, 3) microdosed subcutaneous semaglutide. At baseline and every 4 weeks thereafter, participants will be asked to complete surveys on health, wellness, mood, demographic information, and similar. Additionally, at baseline and every 12 weeks thereafter, they will be requested to complete evaluative blood work to measure CBC, CMP, and standard health biomarker panels (e.g., cholesterol, glucose, creatinine, sodium, potassium). From baseline throughout the duration of the study, participants will be given the option to share data from wearable activity and health trackers with the research team for greater accuracy in evaluating measures of activity, sleep, heart rate, and similar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New or existing AgelessRx patient\n* Adults (aged 18-65)\n* Any sex\n* Any ethnicity\n* BMI ≥ 20 kg/m\\^2\n* Interest in taking microdoses of semaglutide for health and longevity improvement with no intent to seek weight loss improvement.\n\nExclusion Criteria:\n\n* Individuals who are denied a longevity product by the AgelessRx medical team will not be asked to participate in any product specific test(s) or questionnaire(s)\n* History of bariatric surgery\n* Use of other weight-loss medications currently or within the past 6 months\n* Contraindications to semaglutide\n* Significant psychiatric illness that may affect participation\n* Pregnant or breastfeeding individuals'}, 'identificationModule': {'nctId': 'NCT07092605', 'briefTitle': 'Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures', 'organization': {'class': 'INDUSTRY', 'fullName': 'AgelessRx'}, 'officialTitle': 'Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures: For Use in Healthy Individuals Ages 18-65 Who Seek to Improve Their Health and Longevity Through Low-dose (Microdosed) GLP1 Receptor Agonists', 'orgStudyIdInfo': {'id': 'ALRx010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Oral Placebo', 'description': 'Placebo administered in PCCA sub-magna compounding base only.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sublingual GLP1', 'description': 'Semaglutide 1mg/1ml administered in PCCA sub-magna compounding base only.', 'interventionNames': ['Drug: GLP-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subcutaneous GLP1', 'description': 'Semaglutide 1mg/ml x5ml', 'interventionNames': ['Drug: GLP-1']}], 'interventions': [{'name': 'GLP-1', 'type': 'DRUG', 'otherNames': ['Semaglutide'], 'description': 'Sublingual GLP1 (weekly), Subcutaneous GLP1 (weekly), Sublingual Placebo (weekly) for up to 6 months.', 'armGroupLabels': ['Subcutaneous GLP1', 'Sublingual GLP1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sublingual Placebo (weekly) for up to 6 months', 'armGroupLabels': ['Oral Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'AgelessRx', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AgelessRx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}