An Open Label, Long-term Extension Study to Evaluate the Safety and Efficacy of CRN00808 in Subjects With Acromegaly (ACROBAT Advance)

Crinetics Pharmaceuticals Inc.25 sites in 7 countries43 target enrollmentJanuary 29, 2020

ConditionsAcromegaly

InterventionsPaltusotine

DrugsPaltusotine

Overview

Phase: Phase 2
Intervention: Paltusotine
Conditions: Acromegaly
Sponsor: Crinetics Pharmaceuticals Inc.
Enrollment: 43
Locations: 25
Primary Endpoint: Incidence of treatment-emergent adverse events (TEAEs) throughout the study
Status: Active, Not Recruiting
Last Updated: 10 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 29, 2020

End Date

March 1, 2028

Last Updated

10 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Crinetics Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Completed one of the parent studies (Acrobat Evolve \[CRN00808-02\] or Acrobat Edge \[CRN00808-03\])
•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 Criteria

•Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
•Pituitary radiation since completing participation in parent studies
•History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
•Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
•History of alcohol or substance abuse in the past 12 months
•Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
•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, 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