Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Anthony Heaney (ucla)

Description

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.

Official Title

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

Keywords

Acromegaly, ACROBAT, ADVANCE, Paltusotine

Eligibility

You can join if…

Open to people ages 18-75

  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

You CAN'T join if...

  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

Locations

  • Crinetics Study Site
    Los Angeles California 90095 United States
  • Crinetics Study Site
    Portland Oregon 97239 United States

Lead Scientist at University of California Health

  • Anthony Heaney (ucla)
    Dr. Anthony Heaney holds the Burnett Family Chair.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Crinetics Pharmaceuticals Inc.
ID
NCT04261712
Phase
Phase 2 Acromegaly Research Study
Study Type
Interventional
Participants
About 43 people participating
Last Updated