Carcinoid Syndrome Efficacy Study Featuring An Oral Daily Paltusotine Regimen

Study Overview

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

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.

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 Syndrome
Carcinoid
Carcinoid Tumor
Carcinoid Tumor of Ileum
Carcinoid Tumor of Cecum
Carcinoid Tumor of Liver
Carcinoid Tumor of Pancreas
Carcinoid Syndrome Diarrhea
Carcinoid Intestine Tumor

DRUG: Paltusotine
DRUG: Placebo

CRN00808-12
2024-519875-24-00 (CTIS Identifier) (CTIS: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-07-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-23
First Submitted that Met QC Criteria 2025-07-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-25
First Posted (ACTUAL) 2025-07-25	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Paltusotine 80 mg daily	DRUG: Paltusotine Experimental Drug: Randomized
PLACEBO_COMPARATOR: Placebo	DRUG: Placebo Matching Placebo Drug: Randomized

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Paltusotine 80 mg daily

DRUG: Paltusotine

Experimental Drug: Randomized

PLACEBO_COMPARATOR: Placebo

DRUG: Placebo

Matching Placebo Drug: Randomized

Primary Outcome Measures	Measure Description	Time Frame
Participants will record the number of flushing per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing flushing episodes.	Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.	Measured at Week 12

Secondary Outcome Measures	Measure Description	Time Frame
Participants will record the number of bowel movements (BMs) per day in a daily diary to assess the efficacy of paltusotine vs placebo in reducing BMs/day.	Treatment group difference of change from baseline to Week 12 in BMs/day averaged over the 14 days prior to Week 12.	Measured at Week 12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Crinetics Clinical Trials

Phone Number: 833-827-9741

Email: clinicaltrials@crinetics.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

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