TEPH: Telaglenastat for Pulmonary Hypertension
This study is looking into how well a drug called Telaglenastat works for adults with Pulmonary Hypertension (PH), a condition affecting blood vessels in the lungs. Researchers believe Telaglenastat might help lower blood pressure in the lungs and improve heart and lung function. To join, you need to be between 18 and 75 years old and have PH. The main goal is to see if Telaglenastat can improve your Pulmonary Vascular Resistance (PVR), which is measured by a Right Heart Catheterization (RHC) at the beginning and after 12 weeks of treatment. This study plans to enroll 28 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 28 participants.
- What's involved
- You would have a screening visit, a baseline visit with tests like a physical exam, 6-minute walk test, and Right Heart Catheterization (RHC), followed by weekly or bi-weekly treatment visits for 12 weeks, and an end-of-treatment visit with similar tests. There is an optional extension for an additional 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at week 12, with an optional extension for reassessment up to week 24.
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NCT07223528
TEPH: Telaglenastat Efficacy in Pulmonary Hypertension
Not Yet Recruiting
PHASE1Ages 18–75InterventionalTreatmentChan, Stephen, MD, PhDInvestigator-initiated
~28 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Telaglenastat
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pulmonary Vascular Resistance (PVR) measured via Right Hearth Catheterization (RHC)
Measured over Visit 2 at week 1 and Visit 7 at week 12
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Michael Risbano, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Exclusion
With clinically decompensated heart failure
Uncontrolled hypertension (SBP \> 160 mm Hg, DBP \> 90)
Echocardiographic/MRI
Evidence of moderate-severe mitral regurgitation or mitral stenosis within 6 months of enrollment 2. Group 3 PH-ILD, patients receiving approved therapies other than inhaled Treprostinil for PAH within 60 days before randomization are not eligible for enrollment. 3. Group 1 PH, patients naïve to medical treatment for PH are not eligible for enrollment. 4. History of lung reduction surgery or likely to undergo lung transplantation within the next 6 months. 5. Enrolled in, or planned participation in, device or other interventional clinical studies or cardio-pulmonary rehabilitation programs, based upon exercise within 90 days of Screening or during study participation. 6. Patients with other secondary causes of PH including, but not limited to, left or right heart failure, valvular heart disease, chronic obstructive lung disease, atrial septal defect with left to right shunt, and sleep apnea will be excluded if it was the primary cause of PAH. 7. Diagnosed with significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease 8. Uncontrolled hypertension (SBP \> 160 mm Hg, DBP \> 90) 9. Left ventricular ejection fraction (LVEF) \< 45% 10. Adult congenital heart disease (ACHD) 11. Sustained systolic blood pressure (SBP) \< 95 mmHg and/or diastolic blood pressure (DBP) \< 50 mmHg (confirmed by duplicate seated readings) on at least 3 consecutive occasions (self-monitored or office) prior to or at Screening, or overt symptomatic hypotension 12. Sustained resting heart rate (HR) \> 120 beats per minute (confirmed by duplicate assessments of office vital signs) or consecutive electrocardiogram (ECG) assessments on at least 3 consecutive occasions prior to or at Screening 13. Concomitant medical or psychiatric disorder, condition, history, or any other condition that, in the opinion of the Investigator, would either put the participant at risk or impair their ability to participate in or complete the requirements of the study or confound the objectives of the study 14. Concomitant medical disorder that is expected to limit the subject's life-expectancy to ≤ 1 year 15. Untreated, moderate to severe obstructive sleep apnea 16. Evidence of thrombocytopenia (platelets \< 150,000/mm³), significant chronic thromboembolic disorder, or recent pulmonary embolism within 6 months prior to Screening 17. History of a bleeding disorder 18. Known porphyria, mitochondrial, or urea cycle disease 19. History of chronic pancreatic disease 20. Pregnant or lactating female 21. Active coronavirus disease 19 (COVID-19); however, those with previous COVID-19 are permitted 22. Participated in another investigational drug study within 30 days prior to Screening or is participating in a non-medication study which, in the opinion of the Investigator, would interfere with the study compliance or outcome assessments 23. Glomerular Filtration Rate (GFR) of \< 30 mL/min/1.73m² 24. Significant liver dysfunction as measured by any one of the following at Screening (including subjects with acute or chronic hepatitis as well as subjects with own or family history of serious hepatitis, especially drug related):
Alanine aminotransferase (ALT) \> 2.0 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) \> 2.0 × ULN
Serum bilirubin ≥ 1.6 mg/dL or \> 2.0 × ULN 25. Known history of substance abuse including alcohol abuse within the 1 year prior to Screening that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study 26. Any major surgical procedure or trauma within 30 days prior to Screening or planned surgical procedure during the study period.
What this trial measures
- Pulmonary Vascular Resistance (PVR) measured via Right Hearth Catheterization (RHC)Visit 2 at week 1 and Visit 7 at week 12
We will use PVR to measure the effect of treatment on PH