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NCT05361668 (Paltusotine in Carcinoid Syndrome): BVCT ex-ante prediction vs. reported outcome

On 14 Aug 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 12 Mar 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05361668
Drug Name
Paltusotine
Drug MoA
SST2R agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Carcinoid Syndrome
Human Patients
36
Sponsor
Crinetics Pharmaceuticals
Phase
Phase 2

Prediction of , index 1059

Prospective Prediction
Prediction Index
1059
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to octreotide)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
211 days in advance
Readout Data Interpretation
63% reduction flushing frequency and 60% reduction in bowel movement frequency p<0.0001; both superior to the 20-35% reduction in flushing and bowel movement achieved by SoC (DOI- 10.1093/annonc/mdy293.007).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome
Phase
Phase 2
Status
Completed
Enrollment
36
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
DRUG: Randomized: 40 mg Paltusotine; DRUG: Randomized: 80 mg Paltusotine
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-04-22
Primary completion
2024-03-07
Completion
2026-02-24
Results first posted
2025-10-31
Primary outcomes
  • Safety - Incidence of Treatment-emergent Adverse Events (TEAEs) (First dose of investigational medicine to End of Randomized Treatment Phase (8 weeks))

NCT05361668 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials