CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Randomized: 40 mg Paltusotine +1 moredrug
Likely dose
Randomized: 40 mg Paltusotinefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05361668
NCT05361668Phase 2Completed
CompareCT.gov

A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome

Crinetics Pharmaceuticals Inc.·interventional·Posted May 5, 2022·Updated Mar 19, 2026

In Brief

A Phase 2 clinical trial evaluating Randomized: 40 mg Paltusotine and Randomized: 80 mg Paltusotine for Carcinoid Syndrome and 8 related conditions. Completed, enrolled 36 participants across 35 sites in 7 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Syndrome Diarrhea, Carcinoid Intestine Tumor, Carcinoid Tumor of Liver, Carcinoid Tumor of Pancreas
CountriesArgentina, Brazil, Canada, Mexico, Peru, Poland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMay 5, 2022
Enrollment StartApr 22, 2022
Primary CompletionMar 7, 2024
Study CompletionFeb 24, 2026
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.2 years ago

Interventions

Randomized: 40 mg Paltusotinedrug

Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)

Randomized: 80 mg Paltusotinedrug

Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)