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Looking for participantsPhase3

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Sponsor: Crinetics Pharmaceuticals Inc.

NCT ID: NCT07087054

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Paltusotine (drug), Placebo (drug)
How long the study runs
Study runs about 50 months (dates as stated)
About the drug or intervention
Paltusotine — drug: Experimental Drug: Randomized · Placebo — drug: Matching Placebo Drug: Randomized
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at whether a daily tablet called paltusotine can help people with carcinoid syndrome, a condition caused by neuroendocrine tumours (NETs) that can cause flushing (red, hot skin) and diarrhoea. The study is run by Crinetics Pharmaceuticals Inc.

Who can take part

  • Adults aged 18 or over
  • Have carcinoid syndrome that needs medical treatment, with flushing symptoms (with or without frequent bowel movements). People not on somatostatin receptor ligand (SRL) treatment must have more than 1 flushing episode per day on average over 14 days. People stopping SRL treatment must have more than 1 flushing episode per day on average during the washout period
  • Able and willing to follow the study procedures, including completing at least 70% of the study diary over 2 weeks
  • Have a confirmed diagnosis of a well-differentiated neuroendocrine tumour (NET) that is locally advanced or has spread
  • No significant disease progression in the last 6 months, in the investigator's view

Who may not be able to

  • Diarrhoea caused by something other than carcinoid syndrome
  • Severe or uncontrolled diarrhoea causing dehydration, fluid loss or low blood pressure
  • Needing second-line treatments (for example telotristat) for carcinoid syndrome symptoms
  • Certain cancer treatments shortly before the study, such as everolimus or sunitinib within 4 weeks, or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT) or tumour debulking surgery within 12 weeks
  • Major surgery within 8 weeks before screening
  • Another primary cancer within the last 3 years, with some exceptions
  • Diabetes treated with insulin for less than 6 weeks before joining the study
  • Poorly controlled diabetes (HbA1c of 8.5% or higher)
  • Cannot take short-acting octreotide injections, or did not respond to somatostatin medicines before
  • Other serious health conditions not caused by the condition being studied, including certain heart, kidney or liver problems
  • Alcohol or drug abuse at any time during the study
  • Symptomatic gallstones (cholelithiasis)

What taking part involves

  • • Taking paltusotine as a tablet once a day
  • • Keeping a study diary and completing at least 70% of it over a 2-week period

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and exactly what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
141
Started
2025-11-19
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for carcinoid syndrome
  • • Phase3 - 141 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with carcinoid syndrome

Where?

  • • London - King's College Hospital
  • • Oxford - Oxford University Hospitals NHS Foundation Trust
  • • Birmingham - Queen Elizabeth Hospital Brimingham
  • • Cardiff - University Hospital of Wales
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a global, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of paltusotine in adults with carcinoid syndrome. The study includes a screening period of up to 11 weeks, a double-blinded randomized control period of 16 weeks, an open label extension period of 104 weeks, and a follow-up period of 4 weeks.

Carcinoid SyndromeCarcinoidCarcinoid TumorCarcinoid Tumor of IleumCarcinoid Tumor of CecumCarcinoid Tumor of LiverCarcinoid Tumor of PancreasCarcinoid Syndrome DiarrheaCarcinoid Intestine Tumor

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or...
  • ✓For participants who are naïve/not currently treated with somatostatin receptors ligands (SRL), they must exhibit an...
  • ✓Evaluable documentation of that has grown locally or that has spread histopathologically confirmed well-differentiated...

Who cannot take part

  • ✗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...
  • ✗Major surgery within 8 weeks before Screening.
  • ✗Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
See the full 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 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

Where Is This Study? (8 UK sites)

King's College Hospital

London SE59RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Oxford University Hospitals NHS Foundation Trust

Oxford OX37LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Queen Elizabeth Hospital Brimingham

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

University Hospital of Wales

Cardiff CF144XW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elen de Lacy

PHW.Research@wales.nhs.uk02920 104468

The Beatson WOS Cancer Centre

Glasgow G120YN, United Kingdom

Recruiting

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

NIHR Clinical Research Facility, Royal Hallamshire Hospital

Sheffield S102JF, United Kingdom

Recruiting

University Hospital Southampton NHS Foundation Trust

Southampton SO166YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Crinetics Clinical Trials

Sponsor contact

CONTACT

833-276-4636 clinicaltrials@crinetics.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06