Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT07087054
Run by: Crinetics Pharmaceuticals Inc.
People needed: 141
Starts: 2025-11-19
Expected to finish: 2030-01-01
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 be symptomatically controlled and 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.

You may not qualify if…

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 has been completely locally excised and carcinoma in situ of the cervix has also been resected, 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
Alcohol or drug abuse is not permitted at any time during the study
Diagnosed with symptomatic cholelithiasis

Where it is running

Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
Yale University - New Haven Hospital - Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
Winshop Cancer Institute - Emory University — Atlanta, Georgia, United States (enrolling)
University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
University of Kentucky Medical Center — Lexington, Kentucky, United States (enrolling)
University of Miami — Miami, Florida, United States (enrolling)
Henry Ford Cancer - Detroit — Detroit, Michigan, United States (enrolling)
Mayo Clinic — Rochester, Minnesota, United States (enrolling)
Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
University of Virginia Comprehensive Cancer Center — Charlottesville, Virginia, United States (enrolling)
Medical College of Wisconcin — Milwaukee, Wisconsin, United States (enrolling)
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo — Buenos Aires, Argentina (enrolling)
Louisiana State University Health Sciences — Metairie, Louisiana, United States (enrolling)
Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - Investigaciones — Buenos Aires, Argentina (enrolling)
Instituto Médico Especializado Alexander Fleming — Buenos Aires, Argentina (enrolling)
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo — CABA, Argentina (enrolling)
Instituto Médico de la Fundación Estudios Clínicos — Santa Fe, Argentina (enrolling)
AC Camargo Cancer Center — São Paulo, Brazil, Brazil (enrolling)
Fundacao PIO XII - Hospital de Amor Barretos — Barretos, Brazil (enrolling)
Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José — Criciúma, Brazil (enrolling)

Full record on ClinicalTrials.gov

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