NCT07087054

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a global, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of paltusotine in adults with carcinoid syndrome. The study includes a screening period of up to 11 weeks, a double-blinded randomized control period of 16 weeks, an open label extension period of 104 weeks, and a follow-up period of 4 weeks.

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
• Carcinoid Intestine Tumor

Interventions

Type	Name	Description
DRUG	Paltusotine	Experimental Drug: Randomized
DRUG	Placebo	Matching Placebo Drug: Randomized

Timeline

• Start date: 2025-11-19
• Primary completion: 2027-08-01
• Completion: 2030-01-01
• First posted: 2025-07-25
• Last updated: 2026-03-10

Locations

43 sites across 8 countries: United States, Argentina, Brazil, Chile, Colombia, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study