For Healthcare Professionals

A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following 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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details



Age (in years)

18 - 75


Phase 2

Participants needed


Est. Completion Date

Jan 31, 2026

Treatment type



Crinetics Pharmaceuticals Inc. identifier


Study number


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