A Phase 2 Study of RTA 901 in Patients With Diabetic Peripheral Neuropathic Pain (CYPRESS)
Status:
Not yet recruiting
Trial end date:
2026-08-01
Target enrollment:
Participant gender:
Summary
This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the
safety, tolerability, efficacy, and PK of RTA 901 in qualified subjects with DPNP. Each study
part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and a Placebo.
The doses of RTA 901 in Part 2 will be selected based on the Exposure-Response (E-R) analyses
of data from Part 1. A total of 384 subjects will be randomized in this study. Each part will
have 192 subjects, with 64 subjects randomized 1:1:1 to each treatment arm.
The duration of each part of the study will be approximately 20 weeks, including a Screening
Period of up to 2 weeks, a Run-in Period of 2 weeks, a Treatment Period of 12 weeks, and a
Follow-up Period of 4 weeks. All subjects in Part 1 and Part 2 of the study will follow the
same visit and assessment schedule. Eligibility will be assessed during the Screening and
Run-in Periods.