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Daily oral paltusotine for managing carcinoid syndrome

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

Phase 3 Interventional Crinetics Pharmaceuticals Inc. · NCT07087054

This trial tests whether a once-daily oral pill called paltusotine can reduce flushing and bowel symptoms in adults with carcinoid syndrome from well-differentiated neuroendocrine tumors.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment141 (estimated)
Ages18 Years and up
SexAll
SponsorCrinetics Pharmaceuticals Inc. Industry-sponsored
Drugs / interventionssunitinib
Locations51 sites (Gilbert, Arizona and 50 other locations)
Trial IDNCT07087054 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, double-blind, placebo-controlled trial compares paltusotine to placebo in adults with carcinoid syndrome from well-differentiated neuroendocrine tumors. After a screening period (up to 11 weeks), participants are randomized into a 16-week double-blind treatment period followed by a 104-week open-label extension and a 4-week follow-up. The study measures symptom control (flushing and bowel movements), safety, and pharmacokinetics. Participants must keep a symptom diary and meet baseline flushing criteria before randomization.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed well-differentiated neuroendocrine tumors who have symptomatic carcinoid syndrome (average >1 flushing episode per day over 14 days) and who can comply with study procedures are ideal candidates.

Not a fit: Patients with poorly differentiated or rapidly progressive disease, those without symptomatic flushing, or those unable to comply with diary requirements or protocol procedures may not derive benefit from this trial.

Why it matters

Potential benefit: If successful, paltusotine could offer an effective once-daily oral option to reduce carcinoid syndrome symptoms and potentially reduce reliance on injectable somatostatin analogs.

How similar studies have performed: Early-phase trials of paltusotine and long-established injectable somatostatin analogs have shown symptom control, but large-scale Phase 3 confirmation for an oral agent is still pending.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Gilbert, Arizona and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoid SyndromeCarcinoidCarcinoid TumorCarcinoid Tumor of IleumCarcinoid Tumor of CecumCarcinoid Tumor of LiverCarcinoid Tumor of PancreasCarcinoid Syndrome Diarrhea
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.