NCT07223528

TEPH: Telaglenastat Efficacy in Pulmonary Hypertension

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 1-4

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Chan, Stephen, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will consist of the following visits: 1. Screening Visit (30-60 mins) * Consenting * Medical history, physical exam, lab tests (blood, urine) * Review of past heart/lung records * Surveys 2. 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 3. Treatment Phase (Visits 3-6, Weeks 1,2,4,8) Telaglenastat 800 mg/twice daily Short visits (30 mins) for: * Physical Exam * Surveys * Labs 4. 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

Interventions

Type	Name	Description
DRUG	Telaglenastat	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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-11-03
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study