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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (8 UK sites)
King's College Hospital
London SE59RS, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford OX37LE, United Kingdom
Queen Elizabeth Hospital Brimingham
Birmingham B15 2TH, United Kingdom
University Hospital of Wales
Cardiff CF144XW, United Kingdom
The Beatson WOS Cancer Centre
Glasgow G120YN, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
NIHR Clinical Research Facility, Royal Hallamshire Hospital
Sheffield S102JF, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton SO166YD, United Kingdom
How to Get in Touch
Crinetics Clinical Trials
Sponsor contactCONTACT
