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

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04261712
• Other study ID #: CRN00808-05
• Secondary ID: U1111-1245-52762
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 29, 2019
• Est. completion date: March 2028

Study information

• Verified date: December 2023
• Source: Crinetics Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Paltusotine
Paltusotine, once daily by mouth

Locations

Country	Name	City	State
Brazil	Crinetics Study Site	Curitiba	PR
Brazil	Crinetics Study Site	Rio De Janeiro
Brazil	Crinetics Study Site	São Paulo
Greece	Crinetics Study Site	Athens
Greece	Crinetics Study Site	Athens
Greece	Hippokration General hospital of Thessaloniki	Thessaloníki
Hungary	Crinetics Study Site	Budapest
Hungary	Crinetics Study Site	Budapest
Hungary	Crinetics Study Site	Pécs
Serbia	Crinetics Study Site	Belgrade
United Kingdom	Crinetics Study Site	Coventry
United States	Crinetics Study Site	Boston	Massachusetts
United States	Crinetics Study Site	Chicago	Illinois
United States	Crinetics Study Site	Columbus	Ohio
United States	Crinetics Study Site	Dallas	Texas
United States	Crinetics Study Site	Los Angeles	California
United States	Crinetics Study Site	Pittsburgh	Pennsylvania
United States	Crinetics Study Site	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Crinetics Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Greece,  Hungary,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs) throughout the study		Week 316
Secondary	Change in insulin-like growth factor-1 (IGF-1) level		Week 16, Week 312
Secondary	Change in growth hormone (GH) level		Week 16, Week 312