Brief Title
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)
Official Title
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)
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; an
oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with
acromegaly that are responders to octreotide LAR or lanreotide depot.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Proportion of subjects who meet responder criteria (based on the mean of two consecutive insulin-like growth factor-1 [IGF-1] measurements ≤ upper limit of normal [ULN])
Secondary Outcome
Change in IGF-1 levels
Condition
Acromegaly
Intervention
Paltusotine
Study Arms / Comparison Groups
Paltusotine
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
13
Start Date
December 18, 2018
Completion Date
August 12, 2020
Primary Completion Date
July 15, 2020
Eligibility Criteria
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 paltusotine
3. 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.
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)
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT03792555
Organization ID
CRN00808-02
Secondary IDs
2018-001833-42
Responsible Party
Sponsor
Study Sponsor
Crinetics Pharmaceuticals Inc.
Study Sponsor
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Verification Date
July 2021