Can a diabetes drug help the lungs? pioglitazone put to the test for pulmonary hypertension
NCT ID NCT06336798
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory Healthcare System
RECRUITINGAtlanta, Georgia, 30322, United States
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