A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
NCT ID: NCT04837040
Last Updated: 2026-01-13
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
58 participants
INTERVENTIONAL
2021-05-12
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Paltusotine
Paltusotine
Paltusotine, tablets, once daily by mouth
Placebo
Placebo
Placebo, tablets, once daily by mouth
Interventions
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Paltusotine
Paltusotine, tablets, once daily by mouth
Placebo
Placebo, tablets, once daily by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
4. Willing to provide signed informed consent
Exclusion Criteria
2. Prior treatment with paltusotine
3. Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
6. Known history of HIV, hepatitis B, or active hepatitis C
7. History of alcohol or substance abuse in the past 12 months
8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
10. Subjects with symptomatic cholelithiasis
11. Subjects with clinically significant abnormal findings during the Screening Period, or any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
12. Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)
18 Years
ALL
No
Sponsors
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Crinetics Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Crinetics Study Site
Los Angeles, California, United States
Crinetics Study Site
Torrance, California, United States
Crinetics Study Site
Baltimore, Maryland, United States
Crinetics Study Site
Boston, Massachusetts, United States
Crinetics Study Site
Philadelphia, Pennsylvania, United States
Crinetics Study Site
Pittsburgh, Pennsylvania, United States
Crinetics Study Site
Nashville, Tennessee, United States
Crinetics Study Site
CABA, Buenos Aires, Argentina
Crinetics Study Site
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Crinetics Study Site
Córdoba, , Argentina
Crinetics Study Site
Ghent, , Belgium
Crinetics Study Site
Fortaleza, Ceará, Brazil
Crinetics Study Site
Curitiba, Paraná, Brazil
Crinetics Study Site
Porto Alegre, Rio Grande do Sul, Brazil
Crinetics Study Site
Rio de Janeiro, , Brazil
Crinetics Study Site
Rio de Janeiro, , Brazil
Crinetics Study Site
Sofia, , Bulgaria
Crinetics Study Site
Bron, , France
Crinetics Study Site
Pessac, , France
Crinetics Study Site
Budapest, , Hungary
Crinetics Study Site
Pécs, , Hungary
Crinetics Study Site
Beersheba, , Israel
Crinetics Study Site
Petah Tikva, , Israel
Crinetics Study Site
Roma, , Italy
Crinetics Study Site
San Isidro, Lima region, Peru
Crinetics Study Site
Bydgoszcz, , Poland
Crinetics Study Site
Poznan, , Poland
Crinetics Study Site
Kemerovo, Kemerovo Oblast, Russia
Crinetics Study Site
Novosibirsk, Novosibirsk Oblast, Russia
Crinetics Study Site
Novosibirsk, Novosibirsk Oblast, Russia
Crinetics Study Site
Samara, Samara Oblast, Russia
Crinetics Study Site
Kazan', Tatarstan Republic, Russia
Crinetics Study Site
Moscow, , Russia
Crinetics Study Site
Moscow, , Russia
Crinetics Study Site
Moscow, , Russia
Crinetics Study Site
Belgrade, , Serbia
Crinetics Study Site
Sheffield, South Yorkshire, United Kingdom
Crinetics Study Site
Coventry, West Midlands, United Kingdom
Crinetics Study Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-005431-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511925-71-00
Identifier Type: CTIS
Identifier Source: secondary_id
CRN00808-09
Identifier Type: -
Identifier Source: org_study_id
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