Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
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 (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acr...
Eligibility Criteria
Inclusion
- Male and female subjects ≥18 years of age
- Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
- 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
- Treatment naïve or treatment-withdrawn acromegaly subjects
- Prior treatment with paltusotine
- Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
- 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 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)
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04837040
Start Date
May 12 2021
End Date
June 1 2027
Last Update
June 12 2025
Active Locations (39)
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1
Crinetics Study Site
Los Angeles, California, United States, 90048
2
Crinetics Study Site
Torrance, California, United States, 90502
3
Crinetics Study Site
Baltimore, Maryland, United States, 21205
4
Crinetics Study Site
Boston, Massachusetts, United States, 02114