Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
Lead Sponsor:
Crinetics Pharmaceuticals Inc.
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 subj...
Eligibility Criteria
Inclusion
- Male and female subjects ≥18 years of age
- Confirmed diagnosis of acromegaly and either medically naïve, not currently treated, or willing to washout during the study screening period.
- Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
- Willing to provide signed informed consent
Exclusion
- Pituitary radiation therapy within 3 years of Screening
- Prior treatment with paltusotine
- History of ineffective or intolerance to octreotide or lanreotide
- History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
- Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
- Known history of HIV, hepatitis B, or active hepatitis C
- History of alcohol or substance abuse in the past 12 months
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
- Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
- Subjects with symptomatic cholelithiasis
- 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
- Subjects currently or previously using pegvisomant or cabergoline (within 16 weeks prior to Screening) or pasireotide LAR (within 24 weeks prior to Screening)
Key Trial Info
Start Date :
December 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT05192382
Start Date
December 17 2021
End Date
January 1 2028
Last Update
June 12 2025
Active Locations (57)
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1
Crinetics Study Site
Aurora, Colorado, United States, 80045
2
Crinetics Study Site
Boston, Massachusetts, United States, 02114
3
Crinetics Study Site
Columbus, Ohio, United States, 43210
4
Crinetics Study Site
Portland, Oregon, United States, 97239