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

NCT07092605 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: ALRx010
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Microdosing GLP1s; Longevity; Weight Management; Quality of Life

Outcome Measures

Primary Outcomes (8)

• 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

  6 months

• 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

  6 months

• 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

  6 months

• 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

  6 months

• 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.

  6 months

• 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

  6 months

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (4)

• Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s

  6 months

• Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s

  6 months

• Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s

  6 months

• Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s

  6 months

Study Arms (3)

Oral Placebo

PLACEBO COMPARATOR

Placebo administered in PCCA sub-magna compounding base only.

Drug: Placebo

Sublingual GLP1

ACTIVE COMPARATOR

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

Drug: GLP-1

Subcutaneous GLP1

ACTIVE COMPARATOR

Semaglutide 1mg/ml x5ml

Drug: GLP-1

Interventions

GLP-1 DRUG

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

Also known as: Semaglutide

Subcutaneous GLP1; Sublingual GLP1

Placebo DRUG

Sublingual Placebo (weekly) for up to 6 months

Oral Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AgelessRx: lead

Study Sites (1)

AgelessRx

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (3)

• 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: 31680842 BACKGROUND

• 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: 27633186 BACKGROUND

• 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.

  PMID: 29617641 BACKGROUND

Related Links

• Link to AgelessRx Research page.

MeSH Terms

Conditions

Inflammation; Agnosia

Interventions

Glucagon-Like Peptide 1; semaglutide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-Center, Prospective, Blinded, Randomised, Controlled Trial

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: July 30, 2025
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-06

Locations

US (1)