A Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly That Are Responders to Octreotide LAR or Lanreotide Depot (ACROBAT Evolve)

Crinetics Pharmaceuticals Inc.11 sites in 8 countries13 target enrollmentMarch 11, 2019

ConditionsAcromegaly

InterventionsPaltusotine Placebo

DrugsPaltusotine Placebo

Overview

Phase: Phase 2
Intervention: Paltusotine
Conditions: Acromegaly
Sponsor: Crinetics Pharmaceuticals Inc.
Enrollment: 13
Locations: 11
Primary Endpoint: Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.

Registry

clinicaltrials.gov

Start Date

March 11, 2019

End Date

August 12, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

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 that is controlled on stable doses of octreotide LAR or lanreotide depot
•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 or radiation therapy at any time prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more than 4 years prior to study entry) with recently documented elevated IGF-1 may be eligible.
•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

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Responder Criteria Was Based on the Mean of Two Consecutive Insulin-like Growth Factor-1 [IGF-1] Measurements ≤ULN at Week 13

Time Frame: 13 Weeks

Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal \[ULN\])

Secondary Outcomes

Change in IGF-1 Levels(From Week 10 to Week 13)
Change in Growth Hormone (GH) Levels(From Week 8 to Week 13)
Change in Total ASD Score Between RWP Baseline/Week 10 and Week 13(From Week 10 to Week 13)