Carcinoid SyndromePhase 2NCT05361668
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
A Phase 2 study testing Randomized: 40 mg Paltusotine and Randomized: 80 mg Paltusotine in people with Carcinoid Syndrome and Carcinoid, run by Crinetics Pharmaceuticals Inc. at 35 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor
- What is being tested?
- Randomized: 40 mg Paltusotine and Randomized: 80 mg Paltusotine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 35 sitesin 7 countries
- Study dates
- 22 Apr 2022to 24 Feb 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy.
- 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.
- Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled
- 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.
- No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing.
Who cannot join
- 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.
- 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.
- 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.
- Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
United States15 sites
Crinetics Study Site
Boston, Massachusetts, 02118
Crinetics Study Site
Cleveland, Ohio, 44106
Crinetics Study Site
Columbus, Ohio, 43210
Crinetics Study Site
Houston, Texas, 77030
Crinetics Study Site
Iowa City, Iowa, 52242
Crinetics Study Site
Lexington, Kentucky, 40506
Crinetics Study Site
Los Angeles, California, 90048
Crinetics Study Site
Los Angeles, California, 90095
Crinetics Study Site
Miami, Florida, 33136
Crinetics Study Site
New Orleans, Louisiana, 70112
Crinetics Study Site
New York, New York, 10029
Crinetics Study Site
Newport Beach, California, 92663
Crinetics Study Site
Rochester, Minnesota, 55905
Crinetics Study Site
Stanford, California, 94305
Crinetics Study Site
Stony Brook, New York, 11794
Brazil6 sites
Crinetics Study Site
Criciúma, Santa Catarina, 88811508
Crinetics Study Site
Fortaleza, Ceará, 60430-275
Crinetics Study Site
Rio de Janeiro, Rio de Janeiro, 20231-092
Crinetics Study Site
Rio de Janeiro, Rio de Janeiro, 22281-100
Crinetics Study Site
Rio de Janeiro, 22061-080
Crinetics Study Site
São Paulo, São Paulo, 01509-010
Argentina5 sites
Crinetics Study Site
CABA, Buenos Aires, C1180 AAX
Crinetics Study Site
CABA, Buenos Aires, C1264AAA
Crinetics Study Site
CABA, Buenos Aires, C1426ANZ
Crinetics Study Site
CABA, C1017AAS
Crinetics Study Site
CABA, C1425BGH
Mexico3 sites
Crinetics Study Site
Mexico City, Cuauhtemoc, 06100
Crinetics Study Site
Querétaro City, Querétaro, 76000
Crinetics Study Site
Querétaro City, Querétaro, 76070
Poland3 sites
Crinetics Study Site
Katowice, 40-514
Crinetics Study Site
Warsaw, 02-351
Crinetics Study Site
Wroclaw, 53-413
Peru2 sites
Crinetics Study Site Peru #1
Lima, 15036
Crinetics Study Site Peru #2
Lima, 15036
About this study
Official title: A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.
Read the detailed description
This is a Phase 2, randomized, open-label, parallel-group, multicenter study designed to evaluate the safety, pharmacokinetics, and efficacy of paltusotine treatment in subjects with carcinoid syndrome. The study was conducted in 2 parts: a Randomized Treatment Phase (RTP) which is completed, and an Open-label Extension (OLE) Phase which is still ongoing. The RTP consisted of paltusotine treatment for 8 weeks. Subjects who completed the RTP were eligible to enter the OLE Phase at the recommendation of the Investigator. In the ongoing OLE Phase, paltusotine is being administered for a further 102 weeks. The total duration of paltusotine treatment for the combined RTP and OLE Phase is up to 110 weeks (28 months).
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Syndrome Diarrhea
- Being tested
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- Keywords
- Neuroendocrine tumor, Paltusotine, CRN00808, Carcinoid syndrome, Lanreotide, Octreotide, Somatostatin agonist
- Medical subject headings
- Serotonin Syndrome, Carcinoid Tumor, Carcinoid Tumors, Intestinal, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized: 40 mg PaltusotineDrug
Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)
Randomized: 80 mg PaltusotineDrug
Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)
| Study group | Role | What they receive |
|---|---|---|
| 40 mg Paltusotine | Experimental | Participants received paltusotine 40mg, in tablet form, orally, daily, for 8 weeks. Receives: Drug: Randomized: 40 mg Paltusotine |
| 80 mg Paltusotine | Experimental | Participants received paltusotine 80mg, in tablet form, orally, daily for 8 weeks. Receives: Drug: Randomized: 80 mg Paltusotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Incidence of Treatment-emergent Adverse Events (TEAEs)
Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose). In addition to all-cause mortality, deaths were categorized by primary cause (e.g., cardiovascular) based on medical adjudication. Events were coded using MedDRA and summarized by treatment group, system organ class, and preferred term.
TEAEs were reported per randomized arm. There were 2 randomized arms (40 mg and 80 mg paltusotine, with up-or down-dose titration permitted for symptom control). Results are analyzed based on the initially assigned randomization arm, regardless of the actual dose received.
Measured: First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks)
Secondary outcomes (1)
Pharmacokinetics (PK) of Paltusotine
Steady state trough levels by dose and visit for Randomized Treatment Phase (RTP).
The "Overall Number of Participants Analyzed" displayed at the top of the PK summary table represents the total number of participants who received each dose at any point during the trial, factoring in dose titrations. PK results are summarized by actual dose taken right before the time of sample collection, rather than by randomized dose. Participants may be included in different dose groups for different visits due to dose titration.
Measured: Measured at each visit (pre and post dose) up to Week 8 (i.e., End of Randomized Treatment Phase [EOR])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start22 Apr 2022
- Primary completion7 Mar 2024
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoid SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361668
- Sponsor's protocol ID
- CRN00808-11
- Status last verified
- Mar 2026
- First submitted
- 27 Apr 2022
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome
- ClinicalTrials.gov ID
- NCT05361668
- Acronym / sponsor ID
- CRN00808-11
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Syndrome Diarrhea
- Keywords
- Neuroendocrine tumor, Paltusotine, CRN00808, Carcinoid syndrome, Lanreotide, Octreotide, Somatostatin agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Crinetics Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Posted 31 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.
Detailed description
This is a Phase 2, randomized, open-label, parallel-group, multicenter study designed to evaluate the safety, pharmacokinetics, and efficacy of paltusotine treatment in subjects with carcinoid syndrome. The study was conducted in 2 parts: a Randomized Treatment Phase (RTP) which is completed, and an Open-label Extension (OLE) Phase which is still ongoing. The RTP consisted of paltusotine treatment for 8 weeks. Subjects who completed the RTP were eligible to enter the OLE Phase at the recommendation of the Investigator. In the ongoing OLE Phase, paltusotine is being administered for a further 102 weeks. The total duration of paltusotine treatment for the combined RTP and OLE Phase is up to 110 weeks (28 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 mg Paltusotine | Experimental | Drug: Randomized: 40 mg PaltusotineParticipants received paltusotine 40mg, in tablet form, orally, daily, for 8 weeks. |
| 80 mg Paltusotine | Experimental | Drug: Randomized: 80 mg PaltusotineParticipants received paltusotine 80mg, in tablet form, orally, daily for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Male or female subjects ≥18 years of age. 2. Documented carcinoid syndrome requiring medical therapy.
- 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.
- Subjects currently treated with lanreotide, octreotide long acting release, or short acting octreotide (subcutaneous or oral) who are currently symptomatically controlled
- 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.
- No significant disease progression as assessed by the Investigator within the last 6 months before initiation of study drug dosing.
Key exclusion criteria (6 listed)
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomized: 40 mg PaltusotineTwo 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg) | Drug | 40 mg Paltusotine |
| Randomized: 80 mg PaltusotineFour 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg) | Drug | 80 mg Paltusotine |
Primary outcome
Safety - Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks)
Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose). In addition to all-cause mortality, deaths were categorized by primary cause (e.g., cardiovascular) based on medical adjudication. Events were coded using MedDRA and summarized by treatment group, system organ class, and preferred term. TEAEs were reported per randomized arm. There were 2 randomized arms (40 mg and 80 mg paltusotine, with up-or down-dose titration permitted for symptom control). Results are analyzed based on the initially assigned randomization arm, regardless of the actual dose received.
1 secondary outcome
Pharmacokinetics (PK) of Paltusotine
Time frame: Measured at each visit (pre and post dose) up to Week 8 (i.e., End of Randomized Treatment Phase [EOR])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Randomized: 40 mg Paltusotine and Randomized: 80 mg Paltusotine in people with Carcinoid Syndrome and Carcinoid, run by Crinetics Pharmaceuticals Inc. at 35 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Brazil, Argentina, Mexico, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) (time frame: First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.