AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CRN00808 IN SUBJECTS WITH ACROMEGALY (ACROBAT ADVANCE)

Phase 1

• Conditions: Acromegaly is typically caused by a growth hormone (GH) secreting tumor in the pituitary. Excess GH secretion results in excess secretion of insulin-like growth factor-1 (IGF-1) from the liver, which causes bone overgrowth, organ enlargement, and changes in glucose and lipid metabolism. The symptoms of acromegaly include abnormal growth of hands and feet and changes in shape of the bones that result in alteration of facial features.; MedDRA version: 20.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-002193-31-GR
• Lead Sponsor: Crinetics Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-05
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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 either surgically sterile, post-menopausal, or using effective method(s) of birth control
3. Willing to provide signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified