Clinical Trial

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Study acronym: CAREFNDR
Recruiting Phase 3
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Summary
A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.
Protocol Amendment History 2 changes
notable Trial sites expanded: 51 -> 67 locations 2026-08-05
notable Trial sites expanded: 43 -> 51 locations 2026-05-01
Trial Details
NCT Number NCT07087054
Lead Sponsor Crinetics Pharmaceuticals Inc.
Conditions Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Tumor of Liver, Carcinoid Tumor of Pancreas, Carcinoid Syndrome Diarrhea +1 more
Enrollment 141 participants
Start Date 2025-11-19
Primary Completion 2027-08 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-04