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New pill aims to tame flushing and diarrhea in rare cancer syndrome

NCT ID NCT07087054

Symptom relief Sponsor: Crinetics Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This Phase 3 trial tests whether the experimental drug paltusotine can reduce flushing and diarrhea in adults with carcinoid syndrome caused by neuroendocrine tumors. About 141 participants will receive either paltusotine or a placebo daily for 12 weeks. The study measures how much symptoms improve compared to a placebo group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
paltusotine
What this could lead to
If it works, this could provide a new daily pill to better control flushing and diarrhea in people with carcinoid syndrome.
What could go wrong
This is a Phase 3 trial, but it's still testing if paltusotine works better than placebo. Results may not confirm benefit, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 141 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

carcinoid syndrome carcinoid tumor cecum neuroendocrine tumor G1 enterochromaffin cell serotonin-producing pancreatic neuroendocrine tumor ileal neuroendocrine tumor G1 intestinal neuroendocrine tumor G1 liver neuroendocrine carcinoma neuroendocrine neoplasm serotonin syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoid Carcinoid intestine tumor Carcinoid syndrome Carcinoid syndrome diarrhea Carcinoid tumor Carcinoid tumor of cecum Carcinoid tumor of ileum Carcinoid tumor of liver Carcinoid tumor of pancreas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    72 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AC Camargo Cancer Center

    RECRUITING

    São Paulo, 01509-010, Brazil

  • APHM- Hopital de la Timone

    RECRUITING

    Marseille, 13005, France

  • Asklepios Kilnic St. Georg

    RECRUITING

    Hamburg, 20099, Germany

  • Associacao Hospitalar Moinhos de Vento

    RECRUITING

    Porto Alegre, 90560-032, Brazil

  • Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino

    RECRUITING

    Turin, 10126, Italy

  • Azienda ospedaliero - Universitaria Sant'Andrea

    RECRUITING

    Rome, 00189, Italy

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • CECIM-Centro de Estudios Cliicos e Investigaciones Medicas

    RECRUITING

    Santiago, 8320000, Chile

  • CHRU Tours - Hopital Trousseau

    RECRUITING

    Chambray-lès-Tours, 37170, France

  • CHU Bordeaux - Hopital Haut-Leveque

    RECRUITING

    Pessac, 33600, France

  • CHU Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 06100, France

  • Centre Hospitalier Universitaire Nantes

    RECRUITING

    Nantes, 44093, France

  • Centro de Endocrinologia y Diabetes Dr. A. Gutman ICM - Investigaciones

    RECRUITING

    Buenos Aires, C1425BGH, Argentina

  • Centro de Oncologia de Precision

    RECRUITING

    Santiago, 7560908, Chile

  • Centro de Oncolégica VIVA

    RECRUITING

    Mexico City, 06760, Mexico

  • Centrum Diagnostyczno-Lecznicze ,,GAMMED"

    RECRUITING

    Warsaw, 02-351, Poland

  • Clinical Universidad Catolica del Maule, Ltda

    RECRUITING

    Maule, 3460000, Chile

  • Dolnośląskie Centrum Onkologii, Hematologii i Pulmonologii; FutureMeds Wroclaw

    RECRUITING

    Wroclaw, 53-673, Poland

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, 00136, Italy

  • Fundacao PIO XII - Hospital de Amor Barretos

    RECRUITING

    Barretos, 14784-400, Brazil

  • Fundacion Jimenez Diaz University Hospital

    RECRUITING

    Madrid, 28040, Spain

  • Groupe Hospitalier Diaconsses Croix Saint Simon

    RECRUITING

    Paris, 75020, France

  • Health Pharma Professional Research S.A de C.V.

    RECRUITING

    Mexico City, 03100, Mexico

  • Henry Ford Cancer - Detroit

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hopital Beaujun - APHP

    RECRUITING

    Clichy, 92110, France

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario San Ignacio

    RECRUITING

    Bogotá, DC, 110231, Colombia

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario y Politecnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

    RECRUITING

    Buenos Aires, 1264, Argentina

  • Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

    RECRUITING

    CABA, 1264, Argentina

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IRCCS Azienda Ospedaliera - Universitaria di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Institute of Oncology "Prof. Dr. Ion Chiricuta" Cluj Napoca

    RECRUITING

    Cluj-Napoca, 400015, Romania

  • Institute of Oncology Bucharest

    RECRUITING

    Bucharest, 022328, Romania

  • Instituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Instituto Médico Especializado Alexander Fleming

    RECRUITING

    Buenos Aires, C1426ANZ, Argentina

  • Instituto Médico de la Fundación Estudios Clínicos

    RECRUITING

    Santa Fe, 2000, Argentina

  • Instituto Nacional de Cancer (INCA)

    RECRUITING

    Rio de Janeiro, 20230-130, Brazil

  • Instituto Nacional de Cancerologia

    RECRUITING

    Bogotá, DC, 110411, Colombia

  • King's College Hospital

    RECRUITING

    London, UK, SE59RS, United Kingdom

  • Louisiana State University Health Sciences

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconcin

    RECRUITING

    Milwaukee, Wisconsin, 53222, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NIHR Clinical Research Facility, Royal Hallamshire Hospital

    RECRUITING

    Sheffield, S102JF, United Kingdom

  • Nucleo de Pesquisa e Desenvolvimento de Medicamentos (MPDM)

    RECRUITING

    Fortaleza, 60430-275, Brazil

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, UK, OX37LE, United Kingdom

  • Queen Elizabeth Hospital Brimingham

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Sanatorio Guemes

    WITHDRAWN

    Buenos Aires, C1180AAX, Argentina

  • Sociedade Literaria e Caritativa Santos Agostinho - Hospital Sao José

    RECRUITING

    Criciúma, 88811-000, Brazil

  • The Beatson WOS Cancer Centre

    RECRUITING

    Glasgow, G120YN, United Kingdom

  • Universitair Ziekenhuis (UZ) Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, SO166YD, United Kingdom

  • University Hospital of Wales

    RECRUITING

    Cardiff, CF144XW, United Kingdom

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kentucky Medical Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Virginia Comprehensive Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Universitätsklinikum Marburg (UKGM)

    RECRUITING

    Marburg, 35043, Germany

  • Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

    RECRUITING

    Katowice, 40-154, Poland

  • Winshop Cancer Institute - Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Wokskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Centrum Wsparcia Badań Klinicznych

    RECRUITING

    Warsaw, 04-141, Poland

  • Yale University - New Haven Hospital - Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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