Clinical trial NCT04261712: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Acromegaly
Keywords: Acromegaly
ACROBAT
ADVANCE
Paltusotine
Lead sponsor: Crinetics Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs) throughout the study
timeFrame: Week 316
Secondary outcomes:
measure: Change in insulin-like growth factor-1 (IGF-1) level
timeFrame: Week 16, Week 312
measure: Change in growth hormone (GH) level
timeFrame: Week 16, Week 312
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Crinetics Study Site
state: California
city: Chicago
country: United States
facility: Crinetics Study Site
state: Illinois
city: Boston
country: United States
facility: Crinetics Study Site
state: Massachusetts
city: Columbus
country: United States
facility: Crinetics Study Site
state: Ohio
city: Pittsburgh
country: United States
facility: Crinetics Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Crinetics Study Site
state: Pennsylvania
city: Dallas
country: United States
facility: Crinetics Study Site
state: Texas
city: Curitiba
country: Brazil
facility: Crinetics Study Site
state: PR
city: Rio De Janeiro
country: Brazil
facility: Crinetics Study Site
city: Rio De Janeiro
country: Brazil
facility: Crinetics Study Site
city: São Paulo
country: Brazil
facility: Crinetics Study Site
city: Athens
country: Greece
facility: Crinetics Study Site
city: Athens
country: Greece
facility: Crinetics Study Site 1
city: Athens
country: Greece
facility: Crinetics Study Site 2
city: Thessaloníki
country: Greece
facility: Crinetics Study Site
city: Budapest
country: Hungary
facility: Crinetics Study Site
city: Budapest
country: Hungary
facility: Crinetics Study Site
city: Pécs
country: Hungary
facility: Crinetics Study Site
city: Belgrade
country: Serbia
facility: Crinetics Study Site
city: Coventry
country: United Kingdom
facility: Crinetics Study Site
city: Leeds
country: United Kingdom
facility: Crinetics Study Site
Study officials:
References: