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Nonsteroidal Anti-inflammatory Drug

Aspirin Dosing for Obesity

Phase 4
Recruiting
Led By Sean Heffron, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 40 and 70 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 9, week 12
Awards & highlights

Study Summary

This trial looks at the effects of aspirin and body weight on blood and neutrophils.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Aspirin can cause side effects like stomach pain, heartburn, nausea, increased risk of bleeding. Rarely it may lead to severe allergic reactions or worsening asthma symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 40 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 9, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 9, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Serum 15R-LXA4
Secondary outcome measures
Change in leukocyte expression of ALX/FPR2
Change in leukocyte expression of BLT1
Change in leukocyte expression of ERV1/ChemR23
+5 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin 325mg
2019
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,375 Previous Clinical Trials
840,666 Total Patients Enrolled
26 Trials studying Obesity
10,995 Patients Enrolled for Obesity
Sean Heffron, MDPrincipal InvestigatorNYU Langone Health

Media Library

Aspirin (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04697719 — Phase 4
Aspirin (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04697719 — Phase 4
~20 spots leftby Jan 2025
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