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Massive study investigates sex differences in popular Heart-Kidney drugs

NCT ID NCT07188545

Knowledge-focused Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at millions of medical records to see if GLP-1 agonists (like Ozempic) and SGLT2 inhibitors (like Jardiance) affect heart, kidney, and metabolic health differently in men versus women. Participants are adults with early-stage cardiovascular-kidney-metabolic syndrome who have taken these drugs. The goal is to find out if sex influences treatment outcomes, which could lead to more personalized care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GLP-1 agonists (e.g., semaglutide) and SGLT2 inhibitors (e.g., empagliflozin)
What this could lead to
If it succeeds, this could show whether these drugs need to be tailored by sex for better heart, kidney, and metabolic health.
What could go wrong
This is an observational study using existing data, not a controlled trial, so it can't prove cause and effect. Results may be influenced by unmeasured factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 23,280,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The data for this study comes from claims and electronic health records data sources. MarketScan and All of Us are nationally representative databases, and therefore contain patients from all over the US. LifeScale is a local database from The Ohio State University Wexner Medical Center (OSUWMC) and contains patients who seek care at OSUWMC inpatient and outpatient facilities. Adult patients included in the study have evidence of CKMS stage 1 or 2, ≥1 prescription for a GLP-1RA, SGLT2i, DPP4i, or obesity medication, and at least 180 days of continuous database enrollment prior to the first prescription for any medication of interest. Patients will be excluded if they have evidence of stage 3 or 4 CKMS, cancer, renal replacement therapy, end stage renal disease, or solid organ transplant during the baseline period (180 days prior to index date), any history of type I diabetes, or missing sex information. These study criteria will be applied to each of the sources of secondary data to co

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Stage 1 or 2 CKMS at baseline * At least one prescription for an intervention or comparator medication after CKMS diagnosis * At least 180 days of continuous enrollment prior to the first prescription for any medication of interest (index date) * Age 18+ at index date Exclusion Criteria: * Stage 3 or 4 CKMS at baseline * Medications of interest during baseline period * Any history of type I diabetes * Cancer at baseline * Renal replacement therapy at baseline * End stage renal disease at baseline * Solid organ transplant at baseline * Missing sex

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder cardiovascular-kidney-metabolic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular-kidney-metabolic syndrome

Contacts and locations

Locations

  • Ohio State University

    Columbus, Ohio, 43202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.