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

Brief Title

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)

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Incidence of treatment-emergent adverse events (TEAEs) throughout the study

Secondary Outcome

 Change in insulin-like growth factor-1 (IGF-1) level

Condition

Acromegaly

Intervention

Paltusotine

Study Arms / Comparison Groups

 Paltusotine

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

43

Start Date

January 29, 2019

Completion Date

January 2026

Primary Completion Date

March 2025

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Brazil

Location Countries

Brazil

NCT ID

NCT04261712

Organization ID

CRN00808-05

Secondary IDs

U1111-1245-5276

Responsible Party

Sponsor

Study Sponsor

Crinetics Pharmaceuticals Inc.

Study Sponsor

, , 

Verification Date

October 2022