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

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

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Paltusotine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paltusotine<br> | Drug: Paltusotine<br>* Paltusotine, once daily by mouth<br>* Other names: CRN00808;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) throughout the study |  | Week 316 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin-like growth factor-1 (IGF-1) level |  | Week 16, Week 312 | 
| Change in growth hormone (GH) level |  | Week 16, Week 312 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly, ACROBAT, ADVANCE, Paltusotine