An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge)

Crinetics Pharmaceuticals Inc.26 sites in 12 countries47 target enrollmentMarch 12, 2019

ConditionsAcromegaly

InterventionsPaltusotine

DrugsPaltusotine

Overview

Phase: Phase 2
Intervention: Paltusotine
Conditions: Acromegaly
Sponsor: Crinetics Pharmaceuticals Inc.
Enrollment: 47
Locations: 26
Primary Endpoint: Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

Registry

clinicaltrials.gov

Start Date

March 12, 2019

End Date

August 31, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Crinetics Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects 18 to 75 years of age
•Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
•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

•Treatment naïve acromegaly subjects
•Prior treatment with paltusotine
•Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
•History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
•Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
•Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
•History of alcohol or substance abuse in the past 12 months
•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

Arms & Interventions

Paltusotine

Intervention: Paltusotine

Outcomes

Primary Outcomes

Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level

Time Frame: 13 Weeks

Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).

Secondary Outcomes

Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)(13 Weeks)
Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN(13 Weeks)