Microdosed GLP-1 for Health Improvement

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: AgelessRx

Must not be taking: Weight-loss medications

Disqualifiers: Bariatric surgery, Psychiatric illness, others

Compensation: Varies

Number of Visits: 7

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how tiny doses of a drug called GLP-1, which can affect appetite and metabolism, may improve health, quality of life, and potentially extend lifespan. Researchers aim to determine if these small doses aid in maintaining a healthy weight and enhancing the body's food processing. Participants will receive either a placebo or the drug in one of two ways: under the tongue or through a small injection. This trial suits individuals who are current or new patients of AgelessRx, have a BMI of 20 or higher, and seek health improvement without focusing on weight loss. As an Early Phase 1 trial, this research explores how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial requires that you have not used other weight-loss medications in the past 6 months. If you are currently taking such medications, you would need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide, the main ingredient in the microdosed GLP-1 treatments under study, is generally safe for humans. The FDA has already approved it for other uses, such as managing type 2 diabetes and reducing the risk of heart attacks. Studies have found that common side effects of semaglutide can include nausea and vomiting, especially at higher doses. For instance, about 11% to 20% of people experienced nausea with semaglutide injections, compared to just 3% to 8% with a placebo.

In this study, semaglutide is used in two forms: under-the-tongue (sublingual) and under-the-skin (subcutaneous). Both forms have been studied separately and show similar side effects. However, the under-the-tongue form is less common, so less information is available about it. Participants should always consult healthcare providers before deciding to join such studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about microdosed GLP-1 treatments because they offer new ways to improve health compared to existing options like full-dose GLP-1 receptor agonists, often used for diabetes and weight management. Unlike standard injections, the sublingual GLP-1 treatment delivers semaglutide under the tongue, potentially improving convenience and adherence. The subcutaneous GLP-1 offers a concentrated form of semaglutide that may enhance its effectiveness. These innovative delivery methods could provide more flexible and user-friendly alternatives for patients.

What evidence suggests that microdosed GLP-1 could be effective for health improvement?

Research has shown that semaglutide, a type of medication, effectively aids weight loss and improves overall health. In this trial, participants may receive semaglutide in different forms. Evidence suggests that the sublingual version, taken under the tongue, can help maintain weight loss. Studies on the subcutaneous version, injected under the skin, have demonstrated significant weight loss, with one study reporting an average weight loss of 14.9% over 68 weeks. This injected form also lowered blood sugar levels and positively affected heart health. Overall, both forms of semaglutide effectively promote weight loss and improve health. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals seeking to improve their overall health, quality of life, and longevity. It's also aimed at those dealing with obesity, depression, inflammation, immune issues, pain management challenges including ocular pain or anosognosia (lack of illness awareness), and a need for increased alertness.

Inclusion Criteria

Any ethnicity

My sex does not affect my eligibility.

BMI ≥ 20 kg/m^2

Exclusion Criteria

Pregnant or breastfeeding individuals

I have not used weight-loss medications in the last 6 months.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys and blood work, and begin sharing data from wearable devices

1 week

1 visit (in-person)

Treatment

Participants receive microdosed GLP-1 receptor agonists or placebo, with surveys every 4 weeks and blood work every 12 weeks

24 weeks

6 visits (in-person), 6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Microdosed GLP-1

Trial Overview

The study tests the effectiveness of microdosed GLP-1 receptor agonists against a placebo in enhancing health and longevity measures. It also looks at how these treatments affect weight management and metabolic health.

How Is the Trial Designed?

Group I: Sublingual GLP1 Active Control 1 Intervention

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

Group II: Subcutaneous GLP1 Active Control 1 Intervention

Semaglutide 1mg/ml x5ml

Group III: Oral Placebo Placebo Group 1 Intervention

Placebo administered in PCCA sub-magna compounding base only.

Who Is Running the Clinical Trial?

AgelessRx

Lead Sponsor

Trials

7

Recruited

280+

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2307563

Semaglutide and Cardiovascular Outcomes in Obesity ...

Semaglutide, a long-acting analogue of GLP-1, administered at a dose of 2.4 mg subcutaneously once weekly for 104 weeks, was found to reduce body weight by a ...

2.

nature.com

nature.com/articles/s41591-022-02026-4

Two-year effects of semaglutide in adults with overweight ...

This weight loss is comparable to the mean reduction of 14.9% (placebo-corrected weight loss of 12.4 percentage points) seen at week 68 in the ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11944337/

Semaglutide as a GLP-1 Agonist: A Breakthrough in Obesity ...

Data from 1615 participants across seven countries who had not previously used injectable glucose-lowering therapy showed significant reductions in HbA1C and ...

4.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2777886

Effect of Continued Weekly Subcutaneous Semaglutide vs ...

With continued semaglutide, mean body weight change from week 20 to week 68 was −7.9% vs +6.9% with the switch to placebo (difference, −14.8 [95 ...

5.

dom-pubs.onlinelibrary.wiley.com

dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15090

The improved health utility of once‐weekly subcutaneous ...

At week 68, semaglutide 2.4 mg was associated with minor health utility score improvements from baseline (all trials), while scores for placebo ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK603723/

Semaglutide - StatPearls - NCBI Bookshelf

Overdose with oral or subcutaneous semaglutide can cause severe nausea, vomiting, and hypoglycemia. Oral semaglutide is often co-administered ...

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf

OZEMPIC (semaglutide) injection, for subcutaneous use

Pool of Placebo-Controlled Trials. The data in Table 1 are derived from 2 placebo-controlled trials (1 monotherapy trial and 1 trial in combination with basal ...

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/semaglutide-subcutaneous-route/description/drg-20406730

Semaglutide (subcutaneous route) - Side effects & dosage

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. ... Safety and efficacy have not been established. Appropriate studies have not been ...

9.

frontiersin.org

frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2021.645563/full

Safety of Semaglutide

When compared with placebo, subcutaneous semaglutide for 30 weeks induced nausea in 11.4 to 20% of the semaglutide-treated patients (placebo 3.3–8%), vomiting ...