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NCT05192382 (Paltusotine in Acromegaly): BVCT ex-ante prediction vs. reported outcome

On 14 Aug 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 19 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
NCT05192382
Acronym
PATHFNDR-2
Drug Name
Paltusotine
Drug MoA
SST2R agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Musculoskeletal Diseases
Indication
Acromegaly
Human Patients
111
Sponsor
Crinetics Pharmaceuticals
Phase
Phase 3

Prediction of , index 1058

Prospective Prediction
Prediction Index
1058
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
218 days in advance
Readout Data Interpretation
56% patients achieved IGF1 level < 1.0% and -2.67 ASD score; superior to the SoC octreitide LAR achieved 23.3% patients achieved IGF1 level < 1.0% and -2.67 ASD score.
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, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)
Phase
Phase 3
Status
Terminated
Enrollment
111
Lead sponsor
Crinetics Pharmaceuticals Inc.
Conditions
Acromegaly
Interventions
DRUG: Paltusotine; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-12-17
Primary completion
2024-01-20
Completion
2026-06-02
Results first posted
2026-01-13
Primary outcomes
  • Percentage of Participants With a Biochemical Response in Insulin-like Growth Factor-1 (IGF-1) at the End of the Randomized Control Phase (EOR) (Week 24)

NCT05192382 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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