TEPH: Telaglenastat Efficacy in Pulmonary Hypertension

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Chan, Stephen, MD, PhD
Study ID
NCT07223528
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Telaglenastat — DRUG
    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 Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-Label Telaglenastat Arm

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC PresybeterianPittsburghPennsylvania15213
Yassmin Al Aaraj, MPH
[email protected]
4126479227

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By research site
UPMC Presybeterian· Pittsburgh, PA

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