Body WeightPhase 4NCT04697719

Body Weight, Aspirin Dose and Pro-resolving Mediators

A Phase 4 study testing Aspirin 81mg and Aspirin 325mg in people with Body Weight, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Body Weight
What is being tested?: Aspirin 81mg and Aspirin 325mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteUnited States
Study dates: 4 Nov 2021to 29 Jan 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Age between 40 and 70 years

Who cannot join

Anti-platelet medication use in the past 7 days
Aspirin intolerance or allergy
Known bleeding or clotting disorder
Chronic inflammatory or connective tissue disease
Immunological deficiency
Diabetes mellitus

Show all 14Show fewer

Prior gastric or bariatric surgery
Active smoking
Platelet count <100,000
Use of omega-3 fatty acid supplementation
Use of drugs or supplements known to inhibit COX-1/COX-2/lipoxygenases
Corticosteroid use
Recent initiation or change in dose of statin therapy
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

Official title: DISCOVER: A Single-site Double-blind Placebo-controlled Randomized Mechanistic Crossover Trial to Assess the Influence of boDy weIght on aSpirin-triggered speCialized prO-resolVing mEdiatoRs

Conditions: Body Weight
Being tested: Aspirin 81mg, Aspirin 325mg
Keywords: Aspirin
Medical subject headings: Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aspirin 81mgDrug
81mg oral capsule
Aspirin 325mgDrug
325mg oral capsule

Study groups in NCT04697719
Study group	Role	What they receive
Aspirin 81mg, Then Aspirin 325mg	Experimental	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. Receives: Drug: Aspirin 81mg; Drug: Aspirin 325mg
Aspirin 325mg, Then Aspirin 81mg	Experimental	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. Receives: Drug: Aspirin 81mg; Drug: Aspirin 325mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Serum 15R-LXA4
Measured: Week 3, Week 6
Change in Serum 15R-LXA4
Measured: Week 9, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 202129 Jan 2025

First posted6 Jan 2021
Study start4 Nov 2021
Primary completion29 Jan 2025
Study completion29 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Body WeightStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: This is a two-phase crossover design with run-in and wash out periods prior to each phase.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04697719
Sponsor's protocol ID: 20-01884
Status last verified: Oct 2026
First submitted: 4 Jan 2021
Last updated: 27 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Body Weight trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DISCOVER: A Single-site Double-blind Placebo-controlled Randomized Mechanistic Crossover Trial to Assess the Influence of boDy weIght on aSpirin-triggered speCialized prO-resolVing mEdiatoRs
ClinicalTrials.gov ID: NCT04697719
Acronym / sponsor ID: 20-01884
Conditions: Body Weight
Keywords: Aspirin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 4 Nov 2021 (actual)
Primary completion: 29 Jan 2025 (actual)
Study completion: 29 Jan 2025 (actual)
First posted: 6 Jan 2021 (actual)
Results: Posted 27 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This is a two-phase crossover design with run-in and wash out periods prior to each phase.

Arm	Type	Receives
Aspirin 81mg, Then Aspirin 325mg	Experimental	Drug: Aspirin 81mg, Drug: Aspirin 325mgAfter 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.
Aspirin 325mg, Then Aspirin 81mg	Experimental	Drug: Aspirin 81mg, Drug: Aspirin 325mgAfter 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.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Age between 40 and 70 years

Key exclusion criteria (14 listed)

Anti-platelet medication use in the past 7 days
Aspirin intolerance or allergy
Known bleeding or clotting disorder
Chronic inflammatory or connective tissue disease
Immunological deficiency

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aspirin 81mg81mg oral capsule	Drug	Aspirin 325mg, Then Aspirin 81mg, Aspirin 81mg, Then Aspirin 325mg
Aspirin 325mg325mg oral capsule	Drug	Aspirin 325mg, Then Aspirin 81mg, Aspirin 81mg, Then Aspirin 325mg

Primary outcome

Change in Serum 15R-LXA4
Time frame: Week 3, Week 6
Change in Serum 15R-LXA4
Time frame: Week 9, Week 12

Results and safety

Results posted to the registry on 27 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aspirin 81mg, Then Aspirin 325mg	49	40
Aspirin 325mg, Then Aspirin 81mg	59	44

Primary outcome: Change in Serum 15R-LXA4

Time frame: Week 3, Week 6. Mean (Standard Deviation). Unit: pg/mL

Measure	Aspirin 81mg, Then Aspirin 325mg n = 37	Aspirin 325mg, Then Aspirin 81mg n = 42
Value	-1.62 (17.8)	1.59 (15.43)

Population analysed: All randomized participants with both the Week 3 and Week 6 blood draws available. Of 40 randomized to the 81mg-then-325mg sequence, 3 were not analyzed (1 missing the Week 3 draw, 2 missing the Week 6 draw). Of 45 randomized to the 325mg-then-81mg sequence, 3 were not analyzed (1 missing the Week 3 draw, 2 missing the Week 6 draw). No imputation was performed.

Primary outcome: Change in Serum 15R-LXA4

Time frame: Week 9, Week 12. Mean (Standard Deviation). Unit: pg/mL

Measure	Aspirin 81mg, Then Aspirin 325mg n = 36	Aspirin 325mg, Then Aspirin 81mg n = 37
Value	0.7 (14.06)	4.34 (2.12)

Population analysed: All randomized participants with both the Week 9 and Week 12 blood draws available. Of 40 randomized to the 81mg-then-325mg sequence, 4 were not analyzed (2 missing the Week 9 draw, 2 missing both draws). Of 45 randomized to the 325mg-then-81mg sequence, 8 were not analyzed (3 missing the Week 9 draw, 2 missing the Week 12 draw, 3 missing both). No imputation was performed.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aspirin 81mg, Then Aspirin 325mg	0 of 40 (0%)	5 of 40 (12.5%)	0 of 40
Aspirin 325mg, Then Aspirin 81mg	0 of 44 (0%)	7 of 44 (15.9%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Related trials for Body Weight

Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer, Cancer-Associated Weight Loss
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sean Heffron, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin 81mg and Aspirin 325mg in people with Body Weight, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum 15R-LXA4 (time frame: Week 3, Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04697719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.