Can a diabetes drug help the lungs? pioglitazone put to the test for pulmonary hypertension

NCT ID NCT06336798

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether pioglitazone, a drug used for diabetes, can improve how cells use oxygen in people with pulmonary hypertension caused by chronic lung disease. Participants take pioglitazone or a placebo daily for 28 days, then switch after a 2-week break. The study measures changes in mitochondrial function and monitors safety.

What this could mean

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

Active substance
pioglitazone (Actos), a diabetes drug, taken as a 30 mg pill daily
What this could lead to
If it works, this could point toward a new treatment for pulmonary hypertension caused by chronic lung disease.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply broadly. Pioglitazone can cause side effects like hypoglycemia and leg swelling.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Started

Dec 2024

Expected to finish

Feb 2028

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.

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: * Provision of a signed and dated informed consent form * Stated willingness to comply with all study procedures for the duration of the study * Confirmed to have pulmonary hypertension (PH) due to chronic lung disease at screening * Pulmonary hypertension is defined based on meeting all three of the following measured at rest during the RHC: * Mean pulmonary artery pressure \>20 mmHg * Pulmonary artery wedge pressure ≤15 mmHg * Pulmonary vascular resistance \> 2 Wood units * Pulmonary hypertension is classified in Group 3: PH associated with lung diseases and/or hypoxia * Medications approved for the treatment of pulmonary hypertension must be at a stable dose for at least 30 days * Ability to take oral medication and be willing to adhere to the study intervention regimen * For females of reproductive potential: agreement to use highly effective contraception during study participation and for an additional 4 weeks after the end of study participation. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner * Agreement to adhere to Lifestyle Considerations (below) throughout the study duration o During this study, participants are asked to arrive in the clinic for study visits in the fasting state. Specifically, participants should abstain from any caloric intake for 6 hours before arrival for the study visit. Exclusion Criteria: * Diabetes mellitus (type 1 or type 2), present within the preceding 1 year * Personal history of symptomatic hypoglycemia within 90 days preceding enrollment * Personal outpatient use of pioglitazone, rosiglitazone, metformin, insulin, or other medications for the indication of diabetes within 90 days preceding enrollment * History of left ventricular failure (systolic or diastolic) * Pulmonary hypertension due to Group 2 PH (PH due to left heart disease) * History of prior or active bladder cancer * Thrombocytopenia (diagnosis or known platelet count ≤120) within 90 days preceding enrollment * Platelet count ≤120 during screening or on the day of enrollment hypertension due to chronic lung disease * Cystic fibrosis * Pregnancy or lactation * Current tobacco use * Known allergic reaction to components of the study medication (pioglitazone) * Treatment with another investigational drug within 30 days

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Emory Healthcare System

    RECRUITING

    Atlanta, Georgia, 30322, United States

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