Crinetics Pharmaceuticals Inc. has announced the initiation of the pivotal Phase 3 CAREFNDR trial, evaluating the efficacy and safety of once-daily, oral paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. This multicenter, randomized, double-blind, placebo-controlled study will enroll 141 adults, both treatment-naïve and previously treated patients. Participants will be randomized in a 2:1 ratio to receive either paltusotine 80 mg or placebo. The primary endpoint is the change in flushing episodes per day from baseline to Week 12, with change in bowel movements per day as a key secondary endpoint. The trial also includes a 104-week open-label extension to assess long-term efficacy, safety, and tumor control. Results from this Phase 3 study have not yet been presented. Global enrollment is expected throughout 2025 and 2026.