Pulmonary HypertensionPhase 1/2TEPHNCT07223528
TEPH: Telaglenastat Efficacy in Pulmonary Hypertension
A Phase 1/2 study testing Telaglenastat in people with Pulmonary Hypertension, run by Chan, Stephen, MD, PhD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Telaglenastat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- For Group 1and 3 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>3.5 WU) at screening..
- Minimum pulmonary vascular resistance (PVR) of >3.5 Wood units by RHC at screening AT screening and on at least 30 days of stable medical therapy.
- For Group 2 PH-HFpEF, documented transthoracic echocardiogram or cardiac MRI with LV ejection fraction ≥50%, along with meeting at least one of the following criteria by echo: Echocardiographic/MRI evidence of (1) diastolic dysfunction, (2) left atrial enlargement (LA diameter >3.6 cm). Prior right heart catheterization data indicating PCWP>15 mm Hg, mPAP > 20 mm Hg and PVR>3.5 WU. Stable heart failure therapy for at least 30 days.
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- 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 (165cm).
- 8.6-minute walk distance (6MWD) ≥100 meters (m) and <550 m at Screening. 9.For Group 1 PH, patients on SOC medical treatment for PH with vasodilators or sotatercept are required to have been receiving a stable dose for at least 3 months before undergoing randomization.
- 10.For Group 3 PH-ILD, documented diagnosis of presence of interstitial lung disease (diffuse parenchymal lung disease) by high resolution lung CT scan within 1year of randomization. Patients with Group 3 PH with connective tissue disease should have confirmed baseline FVC <70% within 1 year of randomization. For subjects with a history of lobectomy or pneumonectomy, and for whom there are no population-based normalization methods, assessment based on residual lung volume will be permitted to assess eligibility. Patients receiving drug treatment (i.e., pirfenidone or nintedanib) for their underlying lung disease or pulmonary hypertension (i.e., inhaled Treprostinil, tadalafil or sildenafil) should receive a stable dose for at least 30 days before undergoing randomization.
- 11.Women of childbearing potential must be willing and able to practice medically acceptable effective contraception during the study and continuing contraception for 30 days after their last dose of study drug. Women who are surgically sterile or those who are post-menopausal for at least 2 years are not considered to be of childbearing
Who cannot join
- Group 3 PH-ILD, patients receiving approved therapies other than inhaled Treprostinil, tadalafil or sildenafil for PAH less than 30 days before randomization are not eligible for enrollment.
- Group 1 PH, patients naïve to medical treatment for PH are not eligible for enrollment.
- History of lung reduction surgery or likely to undergo lung transplantation within the next 6 months.
- 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.
- 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.
- Diagnosed with significant (≥2+ regurgitation) mitral regurgitation or aortic regurgitation.
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- Adult congenital heart disease (ACHD)
- Left ventricular ejection fraction (LVEF) <50%.
- Uncontrolled hypertension (SBP>160 mm Hg, DBP>90).
- 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.
- 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.
- 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.
- Concomitant medical disorder that is expected to limit the subject's life-expectancy to ≤1 year.
- Untreated, moderate to severe obstructive sleep apnea
- Evidence of thrombocytopenia (platelets <150,000/mm3, significant chronic thromboembolic disorder, or recent pulmonary embolism within 6 months prior to Screening.
- History of a bleeding disorder.
- Known porphyria, mitochondrial, or urea cycle disease.
- History of chronic pancreatic disease
- Pregnant or lactating female.
- Active coronavirus disease 19 (COVID-19); however, those with previous COVID-19 are permitted.
- 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
- Glomerular Filtration Rate (GFR) of <30 mL/min/1.73m2.
- 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
- 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
- Any major surgical procedure or trauma within 30 days prior to Screening or planned surgical procedure during the study period.
- Any inpatient hospitalization (defined as >23 hours) within 30 days prior to screening.
- Known hypersensitivity to study drug or any of the excipients of the drug formulation.
- The discretion of the primary investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UPMC Presybeterian
Pittsburgh, Pennsylvania, 15213
Yassmin Al Aaraj, MPH, 4126479227, yaa29@pitt.edu
About this study
Official title: A Phase 2a Single Arm Open Label Safety and Efficacy Study of Telaglenastat Plus Standard of Care in Adults With Functional Class Ii-iii Precapillary Pulmonary Hypertension Across Wsph Groups 1-3
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.
Read the detailed description
The study will consist of the following visits:
- Screening Visit (30-60 mins)
- Consenting
- Medical history, physical exam, lab tests (blood, urine)
- Review of past heart/lung records
- Surveys
- Baseline Visit (Visit 2, 2-3 hrs)
- Physical exam, 6-minute walk test
- Echo, Right Heart Catheterization (RHC)
- High-Resolution CT (HRCT) \& Pulmonary Function Tests (PFTs) if applicable
- Lab tests, ECG, glutamine blood sample
- Surveys
- Treatment Phase (Visits 3-6, Weeks 1,2,4,8) Telaglenastat 800 mg/twice daily Short visits (30 mins) for:
- Physical Exam
- Surveys
- Labs
- Visit 7 End of Treatment (week 12, 2-3 hours) include the following:
- Physical Exam
- 6 Minute Walk Test
- Echo/RHC/ECG
- HRCT/PFT group 3
- Labs
- Surveys
- Optional Extension (Visits 8-12, Weeks 13-24) Same procedures as initial 12 weeks Final visit includes full reassessment
- Conditions
- Pulmonary Hypertension
- Being tested
- Telaglenastat
- Keywords
- pulmonary hypertension, lung disease, telaglenastat
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelaglenastatDrug
The participant will need to come in for a screening visit prior prescribing the medication to confirm eligibility. The visit will include physical exams, labs, right heart cath, and maybe pulmonary function test and chest imaging. Eligible participants will be taking 800 mg Telaglenastat (CB-839) by mouth with food twice a day for a total of 12 weeks. Participants will need to come in for study related visits during this time. At the end of 12 months period, we will need to repeat same activities we did prior to prescribing to medication. Pending FDA approval, eligible participants may continue Telaglenastat for an additional 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Telaglenastat Arm | Experimental | Not described Receives: Drug: Telaglenastat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Vascular Resistance (PVR) measured via Right Hearth Catheterization (RHC)
We will use PVR to measure the effect of treatment on PH
Measured: Visit 2 at week 1 and Visit 7 at week 12
Secondary outcomes (4)
Functional class (FC)
We will use the functional class evaluated by licensed physician based on clinical history.
Functional Class I: No symptoms with normal activity. Class II: Mild symptoms with ordinary activity (e.g., walking, climbing stairs).
Class III: Noticeable symptoms with less-than-ordinary activity; limited daily tasks.
Class IV: Symptoms at rest; unable to perform any physical activity without discomfort.
Measured: The functional class will be determined at week 1 and 12
6 minute walk test
The person walks back and forth along a marked corridor for 6 minutes. They can slow down, stop, or rest if needed. The total distance walked is recorded in meters. Will be completed by clinical research coordinator
Measured: 6MWT will be at week 1 and 12
NT-proBNP
Blood work including NT-proBNP will be drawn by CRC
Measured: Will be measure at week 1 and 12
Glutamine and glutamate plasma levels
Measure serum glutamine/glutamate ratio
Measured: Will be done on screening visit, on week 1 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study startNov 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chan, Stephen, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Synhale Theraputics
- Responsible party
- Principal investigator, Michael Risbano, University of Pittsburgh
- Investigators
- Michael Risbano, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223528
- Sponsor's protocol ID
- STUDY24070041
- Acronym
- TEPH
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared with other individuals for future research and if shared will be shared without identifiers. Participant's medical record information contained within the Research study may be provided to secondary research investigators (i.e., research investigators who are not affiliated with the Comprehensive Pulmonary Hypertension Program at University of Pittsburgh).The type of data shared would include demographic information, past medical history, medications, lab results, right heart Cath hemodynamics and cardiac imaging studies. However, prior to its provision to any secondary investigators, the information shall be de-identified. The Comprehensive Pulmonary Hypertension Program and Comprehensive lung center shall require secondary investigators to obtain regulatory approval prior its provision of de-identified information to the secondary investigators.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Single Arm Open Label Safety and Efficacy Study of Telaglenastat Plus Standard of Care in Adults With Functional Class Ii-iii Precapillary Pulmonary Hypertension Across Wsph Groups 1-3
- ClinicalTrials.gov ID
- NCT07223528
- Acronym / sponsor ID
- TEPH / STUDY24070041
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, lung disease, telaglenastat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Chan, Stephen, MD, PhDUniversity, hospital or other
- Collaborators
- Synhale Theraputics
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will consist of the following visits:
- Screening Visit (30-60 mins)
- Consenting
- Medical history, physical exam, lab tests (blood, urine)
- Review of past heart/lung records
- Surveys
- Baseline Visit (Visit 2, 2-3 hrs)
- Physical exam, 6-minute walk test
- Echo, Right Heart Catheterization (RHC)
- High-Resolution CT (HRCT) \& Pulmonary Function Tests (PFTs) if applicable
- Lab tests, ECG, glutamine blood sample
- Surveys
- Treatment Phase (Visits 3-6, Weeks 1,2,4,8) Telaglenastat 800 mg/twice daily Short visits (30 mins) for:
- Physical Exam
- Surveys
- Labs
- Visit 7 End of Treatment (week 12, 2-3 hours) include the following:
- Physical Exam
- 6 Minute Walk Test
- Echo/RHC/ECG
- HRCT/PFT group 3
- Labs
- Surveys
- Optional Extension (Visits 8-12, Weeks 13-24) Same procedures as initial 12 weeks Final visit includes full reassessment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Telaglenastat Arm | Experimental | Drug: Telaglenastat |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- For Group 1and 3 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>3.5 WU) at screening..
- Minimum pulmonary vascular resistance (PVR) of >3.5 Wood units by RHC at screening AT screening and on at least 30 days of stable medical therapy.
Key exclusion criteria (31 listed)
- Group 3 PH-ILD, patients receiving approved therapies other than inhaled Treprostinil, tadalafil or sildenafil for PAH less than 30 days before randomization are not eligible for enrollment.
- Group 1 PH, patients naïve to medical treatment for PH are not eligible for enrollment.
- History of lung reduction surgery or likely to undergo lung transplantation within the next 6 months.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelaglenastatThe participant will need to come in for a screening visit prior prescribing the medication to confirm eligibility. The visit will include physical exams, labs, right heart cath, and maybe pulmonary function test and chest imaging. Eligible participants will be taking 800 mg Telaglenastat (CB-839) by mouth with food twice a day for a total of 12 weeks. Participants will need to come in for study related visits during this time. At the end of 12 months period, we will need to repeat same activities we did prior to prescribing to medication. Pending FDA approval, eligible participants may continue Telaglenastat for an additional 12 weeks. | Drug | Open-Label Telaglenastat Arm |
Primary outcome
Pulmonary Vascular Resistance (PVR) measured via Right Hearth Catheterization (RHC)
Time frame: Visit 2 at week 1 and Visit 7 at week 12
We will use PVR to measure the effect of treatment on PH
4 secondary outcomes
Functional class (FC)
Time frame: The functional class will be determined at week 1 and 12
6 minute walk test
Time frame: 6MWT will be at week 1 and 12
NT-proBNP
Time frame: Will be measure at week 1 and 12
Glutamine and glutamate plasma levels
Time frame: Will be done on screening visit, on week 1 and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Data may be shared with other individuals for future research and if shared will be shared without identifiers. Participant's medical record information contained within the Research study may be provided to secondary research investigators (i.e., research investigators who are not affiliated with the Comprehensive Pulmonary Hypertension Program at University of Pittsburgh).The type of data shared would include demographic information, past medical history, medications, lab results, right heart Cath hemodynamics and cardiac imaging studies. However, prior to its provision to any secondary investigators, the information shall be de-identified. The Comprehensive Pulmonary Hypertension Program and Comprehensive lung center shall require secondary investigators to obtain regulatory approval prior its provision of de-identified information to the secondary investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Risbano, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Telaglenastat in people with Pulmonary Hypertension, run by Chan, Stephen, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yassmin A Al Aaraj, MPH (14122668980, yaa29@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Vascular Resistance (PVR) measured via Right Hearth Catheterization (RHC) (time frame: Visit 2 at week 1 and Visit 7 at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.