Aims & Objectives

Primary Aim

To determine whether NST-401 improves osteoarthritis-related pain and physical function compared with placebo in adults with symptomatic osteoarthritis of the knee or hip.

Primary Objectives

• Evaluate change in WOMAC Pain score from baseline through Week 12
• Evaluate change in WOMAC Physical Function score from baseline through Week 12

Secondary Objectives

• Evaluate improvement in joint stiffness
• Evaluate overall improvement in WOMAC outcomes
• Evaluate participant-reported overall improvement
• Evaluate changes in mobility and daily functioning
• Evaluate reduction in rescue analgesic use
• Evaluate durability of response through Week 24
• Characterize the safety and tolerability of NST-401

Digital Assessment Objectives

Evaluate protocol-compliant electronic administration of patient-reported outcome assessments through conversational clinical AI. Evaluate whether question-level voice sentiment and affective analysis can provide additional signals related to:

• Participant comprehension
• Response confidence
• Hesitation
• Uncertainty
• Engagement
• Potential misunderstanding
• Potential mismatch between verbal response and vocal expression

Evaluate whether real-time orchestration between the primary Assessment Agent and an Intervention Agent can improve assessment completeness and response integrity without leading or coaching the participant.