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RECRUITINGPHASE3

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

NCT07087054•Crinetics Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female ≥18 years of age, at the time of Screening.
•Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2-week period.
•Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:
•* For participants who are naïve/not currently treated with somatostatin receptors ligands (SRL), they must exhibit an average of \>1 flushing episode/day over a period of 14 days
•* For participants who will wash out from SRL treatment, they must exhibit an increase in daily average flushing episodes and an average of \>1 flushing episode/day over a period of 14 days during the Washout Period.
•Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) \[NETs\].
•No significant disease progression as assessed by the Investigator within the last 6 months before randomization.

Exclusion Criteria

•Diarrhea attributed to any condition(s) other than carcinoid syndrome.
•Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
•Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.
•Treatment with specific NET therapy \<4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking \<12 weeks before Screening.
•Major surgery within 8 weeks before Screening.
•History of another primary malignancy \<3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast or cervix in situ, previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease, concurrent malignancy determined to be clinically stable and not requiring treatment.
•Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
•Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%
•Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.
•Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate 2×upper limit of normal \[ULN\], and/or total bilirubin (TB) \>1.5×ULN. (Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with TB

Locations (43)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Yale University - New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winshop Cancer Institute - Emory University

Atlanta, Georgia, United States

University of Iowa Health Care

Iowa City, Iowa, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Louisiana State University Health Sciences

Metairie, Louisiana, United States

Henry Ford Cancer - Detroit

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

November 19, 2025

Primary Completion Date

August 1, 2027

Completion Date

January 1, 2030

Last Updated

March 10, 2026

Enrollment

141

ESTIMATED participants

Conditions

Carcinoid SyndromeCarcinoidCarcinoid TumorCarcinoid Tumor of IleumCarcinoid Tumor of CecumCarcinoid Tumor of LiverCarcinoid Tumor of PancreasCarcinoid Syndrome DiarrheaCarcinoid Intestine Tumor

Interventions

Paltusotine

DRUG

Placebo

DRUG

Contacts

Crinetics Clinical Trials

CONTACT

833-276-4636 clinicaltrials@crinetics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Inclusion Criteria

Exclusion Criteria

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