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Paltusotine

Phase 3

Carcinoid Syndrome | Small molecule | Oncology |Crinetics Pharmaceuticals, Inc.|Last Updated: Jul 8, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment141
FDA Designations
ORPHAN_DRUG
Clinical trial landscape

Paltusotine · 4 trials · 10 indications

Phase 3 1Phase 2 3
NCT07087054Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine RegimenCarcinoid Syndrome
RECRUITING141 Analytics
PHASE3RECRUITING
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Carcinoid Syndrome
NCT07087054141
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Study Endpoints
Primary Endpoints
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.
Measured at Week 12

Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.

Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Week 316
Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level
13 Weeks

Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).

Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13
13 Weeks

Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal \[ULN\])

Secondary Endpoints
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.
Measured at Week 12
Change in insulin-like growth factor-1 (IGF-1) level
Week 16, Week 312
Change in growth hormone (GH) level
Week 16, Week 312
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Paltusotine 80 mg dailyEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
PaltusotineEXPERIMENTAL -
Interventions
NameTypeDescription
PaltusotineDRUGExperimental Drug: Randomized
PlaceboDRUGMatching Placebo Drug: Randomized
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * 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 thera...

Countries:United StatesArgentinaBrazilChileColombiaFranceMexicoSpainUnited KingdomGermanyGreeceHungarySerbiaItalyNew ZealandPolandRomaniaSlovakia
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Recent Changes (Last 90 Days)
LOWJul 8, 2026NCT04261712primaryCompletionDate: changed
LOWJul 8, 2026NCT04261712primaryCompletionDate: changed
LOWJun 25, 2026NCT07087054lastUpdatePostDate: changed
LOWJun 25, 2026NCT07087054lastUpdatePostDate: changed
LOWJun 25, 2026NCT07087054lastUpdatePostDate: changed
LOWMay 26, 2026NCT07087054primaryCompletionDate: changed
LOWMay 26, 2026NCT04261712primaryCompletionDate: changed
LOWMay 24, 2026NCT07087054studyFirstPostDate: changed
LOWMay 24, 2026NCT04261712studyFirstPostDate: changed