Brief Title
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
Official Title
A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)
Brief Summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Proportion of subjects who maintain biochemical response in IGF-1 (≤1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR)
Secondary Outcome
Change from baseline in IGF-1, in units of ULN, to EOR
Condition
Acromegaly
Intervention
Paltusotine
Study Arms / Comparison Groups
Paltusotine
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
58
Start Date
May 12, 2021
Completion Date
June 2025
Primary Completion Date
July 2023
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects ≥18 years of age 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: 1. Treatment naïve or treatment-withdrawn acromegaly subjects 2.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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT04837040
Organization ID
CRN00808-09
Secondary IDs
2020-005431-70
Responsible Party
Sponsor
Study Sponsor
Crinetics Pharmaceuticals Inc.
Study Sponsor
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Verification Date
November 2022