Recruiting
Phase 2

Pioglitazone

Sponsor:

Emory University

Code:

NCT06336798

Conditions

Pulmonary Hypertension

Pulmonary Hypertension Due to Lung Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pioglitazone 30mg

Placebo

Labs

Study Details

Brief summary:

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).

Conditions

Pulmonary Hypertension

Pulmonary Hypertension Due to Lung Diseases

Study ID

NCT06336798

Start date

Dec 17, 2024

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pioglitazone, Then Placebo

Participants will first receive a 30 mg tablet of Pioglitazone once daily for 28 days. After a washout period of 14 days, they will then receive a Placebo tablet (matching Pioglitazone 30 mg tablet) once daily for 28 days.

experimental: Placebo, Then Pioglitazone

Participants will first receive a Placebo for 28 days. After a washout period of 14 days, they will then receive a 30 mg Pioglitazone tablet once daily for 28 days.

Interventions

Pioglitazone 30mg

Study participants will take Pioglitazone 30 mg PO daily

Placebo

Study participants will take a placebo PO daily

Labs

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

Primary outcome measure

  • Change in Mitochondrial metabolism parameters: Spare respiratory capacity [ Time Frame: Day 1, Day 28, Day 70 ]
  • Change in Mitochondrial metabolism parameters: Maximal respiration [ Time Frame: Day 1, Day 28, Day 70 ]
  • Change in Mitochondrial metabolism parameters: Basal respiration [ Time Frame: Day 1, Day 28, Day 70 ]

Central Contacts and Locations

Central contacts

Aaron Trammell, MD, MSc

404-712-8204awtramm@emory.edu

Jane Gillespie, RN

404-712-8204jegille@emory.edu

Locations

Emory Healthcare System

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jane Gillespie, RN

404-712-8204jegille@emory.edu

Principal Investigator:

Aaron W Trammell, MD, MSc

More Information

Sponsor

Emory University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Pulmonary Hypertension
  • Chronic Lung Disease
  • Pioglitazone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-22.