ACROBAT EVOLVE
Research type
Research Study
Full 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)
IRAS ID
254259
Contact name
Marta Korbonits
Contact email
Sponsor organisation
Crinetics Pharmaceuticals, Inc.
Eudract number
2018-001833-42
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
Acromegaly is a hormonal disorder that results from too much growth hormone (GH) in the body which can lead to a wide range of cardiovascular, respiratory, endocrine and metabolic illnesses, as well as joint pain, weakness and sometimes visual disturbances. The investigational product CRN00808 may normalize hormone levels in acromegaly patients and may improve patient compliance and quality of life by eliminating painful injections and reduce the need for frequent physician office visits. Additionally, it potentially allows physicians to quickly determine a dosing regimen for superior outcomes compared to existing therapies.
The purpose of ACROBAT EVOLVE study is to see if CRN00808 is effective, tolerable and safe in controlling the growth hormone levels of patients with acromegaly who are responding to their current treatment with either octreotide LAR or lanreotide depot.
After a Screening Period (4 - 6 weeks) all eligible patients will receive treatment with CRN00808 beginning with a 10 mg. The Treatment Period (13 weeks) consists of Titration Period (9 weeks) and randomized Withdrawal Period (4weeks). Patients will not receive their previous standard acromegaly treatment, but investigational CRN00808 capsules (3 capsules once daily). The dose of the study drug may be increased in a blinded manner on two occasions during the Titration Period based on laboratory tests results and tolerability of the study drug. After 9 weeks of Titration Period, all patients in the study whose acromegaly continues to respond to treatment, will be randomly assigned to receive either CRN00808 or placebo for an additional 4 weeks (Randomized Withdrawal Period). After this period all subjects will be removed from acromegaly treatment during a 4-week (Follow-up Period).
Approximately 40 male and female subjects (18-70 years old) with acromegaly will participate in this study which will be conducted at approximately 30 investigational sites in Europe and the USA.REC name
London - Central Research Ethics Committee
REC reference
18/LO/1992
Date of REC Opinion
8 Jan 2019
REC opinion
Further Information Favourable Opinion