Trial · NCT05361668
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
NCT05361668, Phase 2, Completed, Crinetics Pharmaceuticals Inc.; results first posted 2025-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome. Trials, record NCT05361668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05361668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
- NCT number
- NCT05361668
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Crinetics Pharmaceuticals Inc.
- Conditions
Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum, Carcinoid Tumor of Cecum, Carcinoid Syndrome Diarrhea, Carcinoid Intestine Tumor, Carcinoid Tumor of Liver, Carcinoid Tumor of Pancreas
- Interventions
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- First posted
- 2022-05-05
- Last updated
- 2026-03-19
- Results first posted
- 2025-10-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 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. |
| Secondary | Pharmacokinetics (PK) of Paltusotine | Measured at each visit (pre and post dose) up to Week 8 (i.e., End of Randomized Treatment Phase [EOR]) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks) | Safety Analysis Set included all randomized participants receiving ≥1 dose. TEAEs (reported per randomized arm) are defined as AEs from first to last dose date (end of RTP, or early term), plus 28 days (Safety follow up). Dose changes at Weeks 2 or 4 were allowed for symptom control (increase) or poor tolerability (decrease). Results are provided by randomized arms (40 mg and 80 mg paltusotine). | participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK) of Paltusotine | Measured at each visit (pre and post dose) up to Week 8 (i.e., End of Randomized Treatment Phase [EOR]) | The PK Analysis Set included all randomized participants with ≥1 paltusotine dose and ≥1 plasma measurement. Post-dose samples were taken 1-3 hrs after dosing, and steady-state troughs were assessed pre and post dose, through Week 8. Primary PK summaries were based on the RTP. Dose adjustments at Weeks 2 or 4 were allowed for symptom control (dose increase) or tolerability (dose decrease). | ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 40 mg Paltusotine | Treatment-Emergent Adverse Events (TEAE) | 16 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 80 mg Paltusotine | Treatment-Emergent Adverse Events (TEAE) | 15 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 40 mg Paltusotine | TEAE Related to CS Symptoms | 10 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 80 mg Paltusotine | TEAE Related to CS Symptoms | 9 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 40 mg Paltusotine | Highest Severity of TEAE: Severe TEAE | 3 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 80 mg Paltusotine | Highest Severity of TEAE: Severe TEAE | 1 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 40 mg Paltusotine | Highest Severity of TEAE: Moderate TEAE | 6 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 80 mg Paltusotine | Highest Severity of TEAE: Moderate TEAE | 7 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 40 mg Paltusotine | Highest Severity of TEAE: Mild TEAE | 7 | participants | |
| Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) | 80 mg Paltusotine | Highest Severity of TEAE: Mild TEAE | 7 | participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 40 mg Paltusotine | 18 | |
| Overall Study | STARTED | 80 mg Paltusotine | 18 | |
| Overall Study | Adverse Event | 40 mg Paltusotine | 1 | |
| Overall Study | Adverse Event | 80 mg Paltusotine | 1 | |
| Overall Study | Physician Decision | 40 mg Paltusotine | 0 | |
| Overall Study | Physician Decision | 80 mg Paltusotine | 3 | |
| Overall Study | Withdrawal by Subject | 40 mg Paltusotine | 0 | |
| Overall Study | Withdrawal by Subject | 80 mg Paltusotine | 1 | |
| Overall Study | COMPLETED | 40 mg Paltusotine | 17 | |
| Overall Study | COMPLETED | 80 mg Paltusotine | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | 40 mg Paltusotine | 6 | 18 | |
| other | Diarrhoea | Gastrointestinal disorders | 80 mg Paltusotine | 9 | 18 | |
| other | Abdominal pain | Gastrointestinal disorders | 40 mg Paltusotine | 3 | 18 | |
| other | Abdominal pain | Gastrointestinal disorders | 80 mg Paltusotine | 6 | 18 | |
| other | Headache | Nervous system disorders | 40 mg Paltusotine | 5 | 18 | |
| other | Headache | Nervous system disorders | 80 mg Paltusotine | 3 | 18 | |
| other | Nausea | Gastrointestinal disorders | 40 mg Paltusotine | 2 | 18 | |
| other | Nausea | Gastrointestinal disorders | 80 mg Paltusotine | 5 | 18 | |
| other | Flushing | Vascular disorders | 40 mg Paltusotine | 3 | 18 | |
| other | Flushing | Vascular disorders | 80 mg Paltusotine | 2 | 18 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 40 mg Paltusotine | 0 | 18 |
| Total, all-cause mortality | 80 mg Paltusotine | 1 | 18 |
| Total, other adverse events | 40 mg Paltusotine | 16 | 18 |
| Total, other adverse events | 80 mg Paltusotine | 15 | 18 |
| Total, serious adverse events | 40 mg Paltusotine | 2 | 18 |
| Total, serious adverse events | 80 mg Paltusotine | 2 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 40 mg Paltusotine vs 80 mg Paltusotine: deaths from any cause | Trial comparisons |
| 40 mg Paltusotine vs 80 mg Paltusotine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05361668
GET https://conductscience.org/api/trials/v1/NCT05361668/results?page=2