Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures

Not Applicable

• Conditions: Alertness; Mood; Pain Management; Longevity; Quality of Life; Inflammation; Immune Health; Weight Management
• Interventions: Drug: Placebo; Drug: GLP-1

• Registration Number: NCT07092605
• Lead Sponsor: AgelessRx

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2024-12-18
• Status Verified: 2025-06
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• New or existing AgelessRx patient
• Adults (aged 18-65)
• Any sex
• Any ethnicity
• BMI ≥ 20 kg/m^2
• Interest in taking microdoses of semaglutide for health and longevity improvement with no intent to seek weight loss improvement.

Exclusion Criteria

• 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)
• History of bariatric surgery
• Use of other weight-loss medications currently or within the past 6 months
• Contraindications to semaglutide
• Significant psychiatric illness that may affect participation
• Pregnant or breastfeeding individuals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Placebo	Placebo	Placebo administered in PCCA sub-magna compounding base only.
Sublingual GLP1	GLP-1	Semaglutide 1mg/1ml administered in PCCA sub-magna compounding base only.
Subcutaneous GLP1	GLP-1	Semaglutide 1mg/ml x5ml

Primary Outcome Measures

Name	Time	Method
Concentration of complete blood cells, as a measure of immunological health, in participants microdosing GLP1s	6 months	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
Change in self-reported pain levels in participants microdosing GLP1s	6 months	Participants will complete an extensive medical questionnaire every 4 weeks over a 24-week period to monitor self-reported pain levels
Concentration of basic metabolites (cholesterol, glucose, creatinine, sodium, potassium), as a measure of immunological health, in participants microdosing GLP1s	6 months	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
Change in heart rate variability in participants microdosing GLP1s	6 months	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.
Changes in sleep patterns in participants microdosing GLP1s	6 months	Wearable health device data will be monitored over the 24-week period assessing REM vs non-REM sleep and reported as a ratio
Change in frequency of physical activity in participants microdosing GLP1s	6 months	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.
Change in mood in participants microdosing GLP1s	6 months	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

Secondary Outcome Measures

Name	Time	Method
Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s	6 months	Changes in triglyceride levels will be assessed every 12 weeks and reported as a percent deviation from baseline

Trial Locations

Locations (1)

AgelessRx; 🇺🇸 Ann Arbor, Michigan, United States