Brief Title
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
Official Title
A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)
Brief Summary
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Proportion of subjects who achieve 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 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
76
Start Date
December 17, 2021
Completion Date
August 2025
Primary Completion Date
August 2023
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects ≥18 years of age 2. Confirmed diagnosis of acromegaly and either medically naïve, not currently treated, or willing to washout during the study screening period. 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. Pituitary radiation therapy within 3 years of Screening 2. Prior treatment with paltusotine 3. History of ineffective or intolerance to octreotide or lanreotide 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 or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 833-827-9741, [email protected]
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT05192382
Organization ID
CRN00808-08
Secondary IDs
2021-001703-32
Responsible Party
Sponsor
Study Sponsor
Crinetics Pharmaceuticals Inc.
Study Sponsor
, ,
Verification Date
March 2023