Effectiveness of Microdosed GLP-1 in Improving Health, Quality of Life, and Longevity Measures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GLP-1, Placebo.
- Who it may be relevant to
- Registry conditions: Longevity, Quality of Life, Mood, Inflammation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug GLP-1
Sublingual GLP1 (weekly), Subcutaneous GLP1 (weekly), Sublingual Placebo (weekly) for up to 6 months. - Drug Placebo
Sublingual Placebo (weekly) for up to 6 months
Primary outcome measures
- Change in self-reported pain levels in participants microdosing GLP1s [Time frame: 6 months]
- Concentration of complete blood cells, as a measure of immunological health, in participants microdosing GLP1s [Time frame: 6 months]
- Concentration of basic metabolites (cholesterol, glucose, creatinine, sodium, potassium), as a measure of immunological health, in participants microdosing GLP1s [Time frame: 6 months]
- Change in mood in participants microdosing GLP1s [Time frame: 6 months]
- Change in heart rate variability in participants microdosing GLP1s [Time frame: 6 months]
- Changes in sleep patterns in participants microdosing GLP1s [Time frame: 6 months]
- Change in frequency of physical activity in participants microdosing GLP1s [Time frame: 6 months]
- Change in frequency of physical activity in participants microdosing GLP1s [Time frame: 6 months]
Secondary outcome measures (4)
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s [Time frame: 6 months]
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s [Time frame: 6 months]
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s [Time frame: 6 months]
- Variation in concentration of metabolic health biomarkers in participants microdosing GLP1s [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- AgelessRx — Ann Arbor
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. PMID 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. PMID 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. PMID 29617641
Identifiers
NCT: NCT07092605 · ALRx010