Not Yet RecruitingPhase 1/2

TEPH: Telaglenastat Efficacy in Pulmonary Hypertension

United States28 participantsStarted 2026-08

Plain-language summary

The research study is being conducted to evaluate the effectiveness of a drug called Telaglenastat in adults diagnosed with Pulmonary Hypertension (PH). PH is a progressive condition that affects the arteries in the lungs, specifically the pulmonary arteries, which carry blood from the right side of the heart to the lungs. Telaglenastat is not currently approved by the Food and Drug Administration for the treatment of PH. However, the study investigators believe that Telaglenastat may help lower blood pressure in the lungs and improve both heart and lung function. It is important to note that the drug will not be available to participants once the study concludes.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female age 18-75 years old.
✓. Able to provide written informed consent.
✓. Able to comply with study procedures, able to undergo cardiac catheterization and exercise testing.
✓. Patients will be identified with PH Group 1-4 PH by an expert clinician in the UPMC Comprehensive Care Center for Pulmonary Hypertension.
✓. For Group 1, 3, and 4 PH, prior right heart catheterization (RHC) should show documented diagnosis of precapillary PH at mean pulmonary arterial pressure (mPAP \> 20 mm Hg, PCWP \< 15 mm Hg, and PVR \> 4 WU) within 1 year of randomization. If patient doesn't have RHC within 1 year, we will repeat RHC at baseline visit. For Group 2 PH, prior right heart catheterization (RHC) should show mean pulmonary arterial pressure mPAP \> 20 mm Hg and PVR \> 4 WU within one year of randomization. If patient don't have RHC within 1 year we will repeat RHC at baseline visit.
✓. Minimum pulmonary vascular resistance (PVR) of \> 4 Wood units by RHC at screening within last 6 months on at least one month of stable medical therapy.
✓. Symptomatic PH classified as WHO functional class II or III.
✓. Body mass index (BMI) 18 to 40 kg/m² at Screening. If BMI is \> 35 kg/m², subject chest circumference should be \< 65 inches (165 cm).

What they're measuring

Pulmonary Vascular Resistance (PVR) measured via Right Hearth Catheterization (RHC)

Timeframe: Visit 2 at week 1 and Visit 7 at week 12

Trial details

NCT IDNCT07223528

SponsorChan, Stephen, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

Yassmin A Al Aaraj, MPH

14122668980 yaa29@pitt.edu

View on ClinicalTrials.gov More Pulmonary Hypertension trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female age 18-75 years old.
✓. Able to provide written informed consent.
✓. Able to comply with study procedures, able to undergo cardiac catheterization and exercise testing.
✓. Patients will be identified with PH Group 1-4 PH by an expert clinician in the UPMC Comprehensive Care Center for Pulmonary Hypertension.
✓. For Group 1, 3, and 4 PH, prior right heart catheterization (RHC) should show documented diagnosis of precapillary PH at mean pulmonary arterial pressure (mPAP \> 20 mm Hg, PCWP \< 15 mm Hg, and PVR \> 4 WU) within 1 year of randomization. If patient doesn't have RHC within 1 year, we will repeat RHC at baseline visit. For Group 2 PH, prior right heart catheterization (RHC) should show mean pulmonary arterial pressure mPAP \> 20 mm Hg and PVR \> 4 WU within one year of randomization. If patient don't have RHC within 1 year we will repeat RHC at baseline visit.
✓. Minimum pulmonary vascular resistance (PVR) of \> 4 Wood units by RHC at screening within last 6 months on at least one month of stable medical therapy.
✓. Symptomatic PH classified as WHO functional class II or III.
✓. Body mass index (BMI) 18 to 40 kg/m² at Screening. If BMI is \> 35 kg/m², subject chest circumference should be \< 65 inches (165 cm).

TEPH: Telaglenastat Efficacy in Pulmonary Hypertension

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

TEPH: Telaglenastat Efficacy in Pulmonary Hypertension

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria