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

Status

Enrolling by invitation

Phase

Early phase 1

Enrollment

150 participants (estimated)

Sponsor

AgelessRx · Industry

Design

Randomized · Single masking

Countries

1 country

United States

Start

1 Nov 2024

Primary completion

1 Nov 2025 (estimated)

Completion

1 Dec 2025 (estimated)

First posted

30 Jul 2025

Last update posted

30 Jul 2025

Conditions

Longevity · Quality of Life · Mood · Inflammation · Immune Health · Pain Management · Weight Management · Alertness

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.

• Placebo comparator

  Oral Placebo

  Placebo administered in PCCA sub-magna compounding base only.

• Active comparator

  Sublingual GLP1

  Semaglutide 1mg/1ml administered in PCCA sub-magna compounding base only.

• Active comparator

  Subcutaneous GLP1

  Semaglutide 1mg/ml x5ml

1. Change in self-reported pain levels in participants microdosing GLP1s

   Time frame · 6 months

   Registry description

   Participants will complete an extensive medical questionnaire every 4 weeks over a 24-week period to monitor self-reported pain levels

2. Concentration of complete blood cells, as a measure of immunological health, in participants microdosing GLP1s

   Time frame · 6 months

   Registry 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

3. Concentration of basic metabolites (cholesterol, glucose, creatinine, sodium, potassium), as a measure of immunological health, in participants microdosing GLP1s

   Time frame · 6 months

   Registry 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

4. Change in mood in participants microdosing GLP1s

   Time frame · 6 months

   Registry 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

5. Change in heart rate variability in participants microdosing GLP1s

   Time frame · 6 months

   Registry 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.

6. Changes in sleep patterns in participants microdosing GLP1s

   Time frame · 6 months

   Registry description

   Wearable health device data will be monitored over the 24-week period assessing REM vs non-REM sleep and reported as a ratio

7. Change in frequency of physical activity in participants microdosing GLP1s

   Time frame · 6 months

   Registry 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.

8. Change in frequency of physical activity in participants microdosing GLP1s

   Time frame · 6 months

   Registry 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.