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New pill could ease carcinoid syndrome Flare-Ups

NCT ID NCT05361668

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 2 trial tested paltusotine, an oral drug, in 36 adults with carcinoid syndrome. The study looked at safety and how the body processes the drug at different doses. Participants were randomly assigned to 40 mg or 80 mg daily, with dose adjustments allowed. The goal is to find a convenient pill option to manage symptoms like diarrhea and flushing.

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 successful, paltusotine could offer a new oral option to control symptoms like diarrhea and flushing in people with carcinoid syndrome.
What could go wrong
This is an early Phase 2 trial with only 36 participants. The drug may not prove effective or safe in larger studies, and side effects are still being evaluated.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Apr 2022

Finished

Feb 2026

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: 1\. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy. 1. Not currently treated with somatostatin receptor ligands agonists for at least 12 weeks prior to screening and actively symptomatic. This can include treatment-naïve subjects. 2. Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled 3. Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor (NET). Tumors must be Grade 1 (Ki-67 index \< 3%, or a mitotic count of \< 2 mitoses per 10 high-power fields, if the Ki-67 index is not available) or Grade 2 (Ki-67 index 3-20%, or a mitotic count of 2-20 mitoses per 10 high-power fields, if the Ki-67 index is not available) per the World Health Organization neuroendocrine neoplasm classification (Rindi and Inzani, 2020). Grade 3 tumors are not eligible. 4. No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing. Exclusion Criteria: 1. Diarrhea attributed to any condition(s) other than carcinoid syndrome. 2. Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension. 3. Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms. 4. Treatment with specific NET tumor 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. 5. History of another primary malignancy \<3 years prior to the date of first dose, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast or cervix in situ, previously treated or concurrent malignancy determined to be clinically stable and not requiring treatment. 6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.

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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

Contacts and locations

Locations

  • Crinetics Study Site

    Los Angeles, California, 90048, United States

  • Crinetics Study Site

    Los Angeles, California, 90095, United States

  • Crinetics Study Site

    Newport Beach, California, 92663, United States

  • Crinetics Study Site

    Stanford, California, 94305, United States

  • Crinetics Study Site

    Miami, Florida, 33136, United States

  • Crinetics Study Site

    Iowa City, Iowa, 52242, United States

  • Crinetics Study Site

    Lexington, Kentucky, 40506, United States

  • Crinetics Study Site

    New Orleans, Louisiana, 70112, United States

  • Crinetics Study Site

    Boston, Massachusetts, 02118, United States

  • Crinetics Study Site

    Rochester, Minnesota, 55905, United States

  • Crinetics Study Site

    New York, New York, 10029, United States

  • Crinetics Study Site

    Stony Brook, New York, 11794, United States

  • Crinetics Study Site

    Cleveland, Ohio, 44106, United States

  • Crinetics Study Site

    Columbus, Ohio, 43210, United States

  • Crinetics Study Site

    Houston, Texas, 77030, United States

  • Crinetics Study Site

    CABA, Buenos Aires, C1180 AAX, Argentina

  • Crinetics Study Site

    CABA, Buenos Aires, C1264AAA, Argentina

  • Crinetics Study Site

    CABA, Buenos Aires, C1426ANZ, Argentina

  • Crinetics Study Site

    CABA, C1017AAS, Argentina

  • Crinetics Study Site

    CABA, C1425BGH, Argentina

  • Crinetics Study Site

    Fortaleza, Ceará, 60430-275, Brazil

  • Crinetics Study Site

    Rio de Janeiro, Rio de Janeiro, 20231-092, Brazil

  • Crinetics Study Site

    Rio de Janeiro, Rio de Janeiro, 22281-100, Brazil

  • Crinetics Study Site

    Criciúma, Santa Catarina, 88811508, Brazil

  • Crinetics Study Site

    São Paulo, São Paulo, 01509-010, Brazil

  • Crinetics Study Site

    Rio de Janeiro, 22061-080, Brazil

  • Crinetics Study Site

    Toronto, M4N 3M5, Canada

  • Crinetics Study Site

    Mexico City, Cuauhtemoc, 06100, Mexico

  • Crinetics Study Site

    Querétaro City, Querétaro, 76000, Mexico

  • Crinetics Study Site

    Querétaro City, Querétaro, 76070, Mexico

  • Crinetics Study Site

    Katowice, 40-514, Poland

  • Crinetics Study Site

    Warsaw, 02-351, Poland

  • Crinetics Study Site

    Wroclaw, 53-413, Poland

  • Crinetics Study Site Peru #1

    Lima, 15036, Peru

  • Crinetics Study Site Peru #2

    Lima, 15036, Peru

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