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

Crinetics Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Acromegaly

Treatments: Drug: Paltusotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04261712

2019-002193-31 (EudraCT Number)

2024-511921-75-00 (EU Trial (CTIS) Number)

CRN00808-05

U1111-1245-5276 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Paltusotine

Experimental group

Treatment:

Drug: Paltusotine