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AzTrials

LongevityEarly Phase 1NCT07092605

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

A Early Phase 1 study testing GLP-1 in people with Longevity and Quality of Life, run by AgelessRx at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Longevity, Quality of Life, Mood
What is being tested?
GLP-1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteUnited States
Study dates
1 Nov 2024to 1 Dec 2025
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • AgelessRx

    Ann Arbor, Michigan, 48104

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
GLP-1, Placebo
Keywords
Microdosing GLP1s, Longevity, Weight Management, Quality of Life
Medical subject headings
Inflammation, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLP-1Drug

    Also called Semaglutide

    Sublingual GLP1 (weekly), Subcutaneous GLP1 (weekly), Sublingual Placebo (weekly) for up to 6 months.

  • PlaceboDrug

    Sublingual Placebo (weekly) for up to 6 months

Study groups in NCT07092605
Study groupRoleWhat they receive
Oral PlaceboPlacebo comparatorPlacebo administered in PCCA sub-magna compounding base only.
Receives: Drug: Placebo
Sublingual GLP1Active comparatorSemaglutide 1mg/1ml administered in PCCA sub-magna compounding base only.
Receives: Drug: GLP-1
Subcutaneous GLP1Active comparatorSemaglutide 1mg/ml x5ml
Receives: Drug: GLP-1

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 6 months

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

    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

    Measured: 6 months

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

    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

    Measured: 6 months

  4. Change in mood in participants microdosing GLP1s

    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

    Measured: 6 months

  5. Change in heart rate variability in participants microdosing GLP1s

    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.

    Measured: 6 months

  6. Changes in sleep patterns in participants microdosing GLP1s

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

    Measured: 6 months

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

    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.

    Measured: 6 months

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

    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.

    Measured: 6 months

Secondary outcomes (4)

  1. Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s

    Changes in HbA1c levels will be assessed every 12 weeks and reported as a percent deviation from baseline

    Measured: 6 months

  2. Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s

    Changes in LDL cholesterol levels will be assessed every 12 weeks and reported as a percent deviation from baseline

    Measured: 6 months

  3. Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s

    Changes in HDL cholesterol levels will be assessed every 12 weeks and reported as a percent deviation from baseline

    Measured: 6 months

  4. Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s

    Changes in triglyceride levels will be assessed every 12 weeks and reported as a percent deviation from baseline

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start1 Nov 2024
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-Center, Prospective, Blinded, Randomised, Controlled Trial
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092605
Sponsor's protocol ID
ALRx010
Status last verified
Jun 2025
First submitted
18 Dec 2024
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 31680842

  • 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.

    PubMed 27633186

  • 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.

    PubMed 29617641

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GLP-1 in people with Longevity and Quality of Life, run by AgelessRx at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-reported pain levels in participants microdosing GLP1s (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07092605, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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