Aspirin Dosing for Obesity

Overseen By Sean Heffron, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must not be taking: Anti-platelets, Omega-3s, Corticosteroids, others

Disqualifiers: Diabetes, Smoking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of aspirin affect blood and immune cell responses in people with obesity. Participants will receive two doses of aspirin, 81mg and 325mg, in a specific sequence with breaks in between. The goal is to determine how body weight influences the body's response to aspirin. Individuals who are obese and do not have conditions such as diabetes, bleeding disorders, or recent gastric surgeries may be suitable for this trial. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial requires that you have not used anti-platelet medications in the past 7 days and that you do not use certain other medications or supplements, like omega-3s or corticosteroids. If you're taking any of these, you may need to stop before participating.

What is the safety track record for aspirin?

Research has shown that aspirin is generally safe for use. One study found no major differences in safety between different doses of aspirin for people of various body weights. This indicates that both low-dose (81mg) and regular-dose (325mg) aspirin can be safe, regardless of weight.

Aspirin is commonly used to relieve pain and lower the risk of heart attacks. However, it can sometimes cause side effects like stomach upset or bleeding, especially with higher doses or long-term use.

Since this trial is in Phase 4, aspirin has already been approved for use, indicating a well-known safety record. However, discussing any concerns with a doctor before using aspirin is always important, especially when considering joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores how different doses of aspirin can be optimized for people with obesity. Unlike standard treatments that focus mainly on lifestyle changes or medication targeting weight loss, this trial investigates the use of aspirin, a common anti-inflammatory drug, to see if different dosing strategies can have beneficial effects in this population. By comparing the effects of a low dose (81mg) and a higher dose (325mg) of aspirin, the trial aims to uncover whether altering the dose can improve outcomes related to obesity, potentially offering a simple yet effective addition to current treatment options.

What is the effectiveness track record for aspirin in treating obesity-related conditions?

This trial will compare different dosing regimens of aspirin for obesity-related issues. Research has shown that aspirin can help with these problems by reducing inflammation in body fat. Studies indicate that a higher dose of aspirin, such as 325 mg, is more effective at reducing blood stickiness, which is crucial for preventing heart problems, especially in obese individuals. In contrast, a lower dose, like 81 mg, is less effective for this purpose. Since obese individuals often have more active blood platelets, the higher dose might be more beneficial for them. Overall, aspirin could help reduce inflammation and improve health in obese patients. Participants in this trial will receive either the 81 mg dose followed by the 325 mg dose, or the 325 mg dose followed by the 81 mg dose, to evaluate the effects of each dosing regimen. ^{1 6 7 8 9}

Who Is on the Research Team?

Sean Heffron, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for non-smoking adults aged 40-70 who are not pregnant, don't have diabetes, bleeding/clotting disorders, immune deficiencies, or chronic inflammatory diseases. They shouldn't have had recent changes in statin drugs or surgeries affecting the stomach and must not be on certain medications including aspirin.

Inclusion Criteria

I am between 40 and 70 years old.

Exclusion Criteria

You are allergic or intolerant to aspirin.

You are currently smoking cigarettes.

I have taken anti-platelet medication in the last week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo Run-in

Participants receive a placebo for 3 weeks before starting the active treatment

3 weeks

Treatment

Participants receive Aspirin 81mg or 325mg daily for 3 weeks, followed by a 3-week placebo washout, then switch doses for another 3 weeks

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin

Trial Overview The study is testing how different doses of aspirin (81mg and 325mg) affect blood levels of substances that help resolve inflammation in obese individuals. It's a placebo-controlled study where participants will receive both doses and a placebo at different times without knowing which one they're getting.

How Is the Trial Designed?

Group I: Aspirin 81mg, Then Aspirin 325mg Experimental Treatment 2 Interventions

After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.

Group II: Aspirin 325mg, Then Aspirin 81mg Experimental Treatment 2 Interventions

After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6787378/

The dilemma of aspirin resistance in obese patients - PMC Results showed that obese individuals had greater baseline platelet reactivity compared to non-obese controls. After low-dose aspirin treatment, platelet ...

2. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.16330

Abstract 16330: Aspirin Dosing by Body Mass Index The overall event rate for the primary outcome was lower in overweight (0.68 [0.57-0.81]) and obese (0.65 [0.55-0.78]) groups compared to normal ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36755519/

Prospective, randomized, controlled, trial to assess ASA ... ASA 81 mg was significantly less effective in reducing platelet aggregation compared with ASA 325 and 500 mg, independent of BMI.

4. atm.amegroups.org atm.amegroups.org/article/view/28019/html

The dilemma of aspirin resistance in obese patients - Ardeshna Results showed that obese individuals had greater baseline platelet reactivity compared to non-obese controls. After low-dose aspirin treatment, platelet ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0024320520313710

Effect of acetylsalicylic acid on inflamed adipose tissue. ... ASA can efficiently ameliorate pathological conditions usually associated with obesity by inhibiting the inflammatory process occurring in the adipose tissue.

6. mayoclinic.org mayoclinic.org/drugs-supplements/aspirin-oral-route/description/drg-20152665

Aspirin (oral route) - Side effects & dosage Aspirin extended-release capsules are used to lower risk of heart attack in patients with chronic coronary artery disease.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10145431/

Pharmacological Efficacy and Gastrointestinal Safety of ... Several studies demonstrated that EC aspirin does not reduce the incidence of clinically relevant gastrointestinal ulceration and bleeding.

8. bayer.com bayer.com/sites/default/files/2020-11/aspirin-pm-en.pdf

Product Monograph ASPIRIN English 28Jun2024 PART I: HEALTH PROFESSIONAL INFORMATION. 1 INDICATIONS. ASPIRIN® (acetylsalicylic acid, ASA) is indicated for the relief of pain, fever, and inflammation of.

9. drugs.com drugs.com/aspirin.html

Aspirin Uses, Dosage, Side Effects & Interactions Aspirin is used to treat pain, and reduce fever or inflammation. It is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina).