A Study to Evaluate the Safety and Efficacy of CRN00808 for the Treatment of Acromegaly



Status:Recruiting
Conditions:Skin Cancer, Endocrine
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - 70
Updated:3/10/2019
Start Date:December 18, 2018
End Date:July 2020
Contact:Crinetics Clinical Trials
Email:clinicaltrials@crinetics.com
Phone:833-827-9741

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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)

A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to
evaluate the safety, efficacy, and pharmacokinetics of CRN00808 (an oral selective nonpeptide
somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are responders
to octreotide LAR or lanreotide depot.


Inclusion Criteria:

1. Male and female subjects 18 to 70 years of age

2. Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR
or lanreotide depot

3. Females must be non-pregnant and non-lactating, and either surgically sterile,
post-menopausal, or using effective method(s) of birth control

4. Willing to provide signed informed consent

Exclusion Criteria:

1. Treatment naïve acromegaly subjects

2. Prior treatment with CRN00808

3. Pituitary surgery within 6 months prior to Screening or radiation therapy at any time
prior to the study entry

4. History or presence of malignancy except adequately treated basal cell and squamous
cell carcinomas of the skin within the past 5 years.

5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is
longer

6. 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

7. History of alcohol or substance abuse in the past 12 months

8. Any condition that in the opinion of the investigator would jeopardize the subject's
appropriate participation in this study

9. Cardiovascular conditions or medications associated with prolonged QT or those which
predispose subjects to heart rhythm abnormalities.

10. Subjects with symptomatic cholelithiasis

11. 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

12. Subjects who have been taking the following prior medications: pegvisomant (within the
last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR
(within the last 6 months)

13. Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a
dose higher than 120 mg

14. Subjects who usually take octreotide LAR or lanreotide depot less frequently than
every 4 weeks (e.g. every 6 weeks or 8 weeks)
We found this trial at
4
sites
Pittsburgh, Pennsylvania 15212
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Munich,
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