Recruiting
Phase 3

Paltusotine

Sponsor:

Crinetics Pharmaceuticals Inc.

Code:

NCT07087054

Conditions

Carcinoid Syndrome

Carcinoid

Carcinoid Tumor

Carcinoid Tumor of Ileum

Carcinoid Tumor of Cecum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paltusotine

Placebo

Study Details

Brief 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.

Conditions

Carcinoid Syndrome

Carcinoid

Carcinoid Tumor

Carcinoid Tumor of Ileum

Carcinoid Tumor of Cecum

Study ID

NCT07087054

Start date

Nov 19, 2025

Status verified date

Jun, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

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 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

Study Design

Enrollment

141 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Paltusotine 80 mg daily

placebo comparator: Placebo

Interventions

Paltusotine

Experimental Drug: Randomized

Placebo

Matching Placebo Drug: Randomized

Primary outcome measure

  • Participants will record the number of flushing per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing flushing episodes. [ Time Frame: Measured at Week 12 ]

Central Contacts and Locations

Central contacts

Crinetics Clinical Trials

833-276-4636clinicaltrials@crinetics.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Yale University - New Haven Hospital - Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

University of Miami

Recruiting

Miami, Florida, United States, 33136

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Winshop Cancer Institute - Emory University

Recruiting

Atlanta, Georgia, United States, 30322

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Louisiana State University Health Sciences

Recruiting

Metairie, Louisiana, United States, 70006

Henry Ford Cancer - Detroit

Recruiting

Detroit, Michigan, United States, 48202

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

University of Virginia Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Medical College of Wisconcin

Recruiting

Milwaukee, Wisconsin, United States, 53222

More Information

Sponsor

Crinetics Pharmaceuticals Inc.

Last update posted

Aug 4, 2026

Last verified

Jun, 2026

Keywords

  • Neuroendocrine tumor
  • Paltusotine
  • CRN00808
  • Carcinoid syndrome
  • Lanreotide
  • Octreotide
  • Somatostatin agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Crinetics Pharmaceuticals Inc. on 2026-08-04.