Paltusotine in Carcinoid Syndrome

Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome

CLINICALTRIALS.GOV IDENTIFIER: NCT05361668

DRUG/TREATMENT: Paltusotine

PHASE: 2

STATUS: Recruiting

SPONSOR: Crinetics Pharmaceuticals Inc.

Dr. Aman Chauhan Discusses Paltusotine in Carcinoid Syndrome

UPDATE: On Tuesday, March 12, 2024, Crinetics Pharmaceuticals announced positive topline results from their Phase 2 study of Paltusotine, a once-daily pill, under investigation for the treatment of carcinoid syndrome. The results show that Paltusotine was generally well-tolerated and reduced the frequency and severity of bowel movements and flushing. The company plans to engage the FDA to initiate a Phase 3 trial by the end of 2024.

To read the announcement, go to the March 12, 2024 press release.

To view the live webcast discussing the data and slides, go to the Paltusotine Study Results Presentation.

UPDATE: On Monday, December 18, 2023, Crinetics announced positive initial findings from their ongoing open-label phase 2 study of paltusotine for the treatment of carcinoid syndrome. Today's announcement states “These initial results show the potential of paltusotine to significantly reduce both frequency and intensity of bowel movements and flushing, the key carcinoid syndrome symptoms. Further, paltusotine was well-tolerated and the overall pharmacokinetic profile was consistent with prior studies. After completing this Phase 2 study next quarter, we anticipate sharing the results with the FDA to align on the design of a Phase 3 program.” 

To read the announcement, go to the December 18, 2023 press release. 

To view the slides from the announcement, go to the, "CRINETICS INITIAL FINDINGS FROM ONGOING OPEN-LABEL PHASE 2 STUDY OF PALTUSOTINE FOR THE TREATMENT OF CARCINOID SYNDROME".

UPDATE: On Sept 10, 2023, Crinetics Pharmaceuticals announced positive results for their paltusotine phase 3 acromegaly study. This is the same once-daily pill that is currently in a phase 2 study for NET patients with carcinoid syndrome. To read the announcement, go to https://crinetics.com/crinetics-paltusotine-achieved-primary-and-secondary-endpoints-in-phase-3-pathfndr-1-acromegaly-study/.

DESCRIPTION:

Crinetics is sponsoring a phase 2 study 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.

For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. For more information, go to LACNETS.CarcinoidStudy.com.

CONTACT:

Crinetics Clinical Trials

EMAIL: clinicaltrials@crinetics.com

PHONE: 833-827-9741