Brief Title
A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)
Official Title
An Open Label, Long-term Extension Study to Evaluate the Safety and Efficacy of CRN00808 in Subjects With Acromegaly (ACROBAT Advance)
Brief Summary
A phase 2, open label, long-term extension 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 acromegaly.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Secondary Outcome
Change in insulin-like growth factor-1 (IGF-1) level
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
43
Start Date
January 29, 2019
Completion Date
January 2026
Primary Completion Date
March 2025
Eligibility Criteria
Inclusion Criteria: 1. Completed one of the parent studies (Acrobat Evolve [CRN00808-02] or Acrobat Edge [CRN00808-03]) 2. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 3. Willing to provide signed informed consent Exclusion Criteria: 1. Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis) 2. Pituitary radiation since completing participation in parent studies 3. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years 4. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab). 5. History of alcohol or substance abuse in the past 12 months 6. Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening 7. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study. 8. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities 9. Subjects with symptomatic cholelithiasis 10. Subjects with clinically significant abnormal findings during the Screening Period, and 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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT04261712
Organization ID
CRN00808-05
Secondary IDs
U1111-1245-5276
Responsible Party
Sponsor
Study Sponsor
Crinetics Pharmaceuticals Inc.
Study Sponsor
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Verification Date
October 2022