Bioenergetic Effect of Pioglitazone in CLD-PH

Effect of Pioglitazone on Mitochondrial Metabolism in Pulmonary Hypertension Due to Chronic Lung Disease

Bioenergetic Effect of Pioglitazone in CLD-PH (NCT06336798) is a Phase 2 interventional studying Pulmonary Hypertension and Pulmonary Hypertension Due to Lung Diseases, sponsored by Emory University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is: • Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD. Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Pulmonary Hypertension and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Provision of a signed and dated willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Pioglitazone 30mg

Study participants will take Pioglitazone 30 mg PO daily

DRUG

Placebo

Study participants will take a placebo PO daily

DIAGNOSTIC_TEST

Labs

Labs will be performed for Urine HCG, Complete Blood count (CBC), Chemistry Panel, Fasting lipids, insulin, glucose, and Bioenergetic analysis (platelets).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Emory Healthcare System

Atlanta, Georgia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06336798), the sponsor (Emory University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06336798 clinical trial studying?

Who can participate in NCT06336798?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06336798?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06336798. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06336798. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.