drugset / Trial / NCT06924970

A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)

NCT06924970 ↗

Phase 2 Active not recruiting 59 enrolled Agios Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main purpose of this study is to compare the effect of tebapivat versus placebo on anemia and to detect a dose-response for hemoglobin (Hb) response in participants with SCD.

Timeline

Start
2025-05-01
Primary completion
2026-05
Completion
2027-05

Outcome

Met primary endpoint

release “The trial’s primary endpoint of hemoglobin response (≥1.0 g/dL increase in average hemoglobin concentration from Weeks 10 through 12 compared with baseline) was achieved” agios.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tebapivat Small molecule 2.5 mg Oral
Subject Tebapivat Small molecule 5 mg Oral
Subject Tebapivat Small molecule 7.5 mg Oral

Indications