103 Participants Needed

Aspirin Dosing for Obesity

NM
SH
Overseen BySean Heffron, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study employs a placebo-controlled randomized cross-over design to investigate the impact of body weight and aspirin dose on levels of specialized pro-resolving lipid mediators in blood and neutrophils.

Research Team

SH

Sean Heffron, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.
See 11 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Aspirin 81mg, Then Aspirin 325mgExperimental Treatment2 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 81mgExperimental Treatment2 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:

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Approved in European Union as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
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Approved in United States as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
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Approved in Canada as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
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Approved in China as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+
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