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Trial registered on ANZCTR
Registration number
ACTRN12615000289516
Ethics application status
Approved
Date submitted
17/03/2015
Date registered
27/03/2015
Date last updated
21/04/2024
Date data sharing statement initially provided
21/04/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A Phase II Open-Label Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ATL1103 300mg in Adult Patients with Acromegaly.
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Scientific title
A Phase II Open-Label Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ATL1103 300mg in Adult Patients with Acromegaly.
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Secondary ID [1]
285876
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Protocol 1103-CT03
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acromegaly
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Condition category
Condition code
Metabolic and Endocrine
294098
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subjects will receive ATL1103 (growth hormone (GH) receptor antisense oligonucleotide) as a sterile aqueous solution administered by subcutaneous injection
Dose regimen 300mg twice a week for 13 weeks
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Intervention code [1]
290857
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Treatment: Drugs
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Safety and tolerability will be assessed by serum chemistry, haematology, urinalysis, physical exam, vital signs, electrocardiogram, MRI, and monitoring and recording adverse events
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Assessment method [1]
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Timepoint [1]
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Over 13 weeks of treatment and 8 weeks of follow up
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Primary outcome [2]
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Single and multiple dose pharmacokinetic parameters
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Assessment method [2]
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Timepoint [2]
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Plasma will be collected for ATL1103 assays pre-dose and at 1, 2, 3, 4 and 6 hours post first and last doses, and pre-dose only on Day 4 of Weeks 1, 2, 4, 6, 8, 10, and 12.
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Secondary outcome [1]
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Efficacy of ATL1103 will be assessed by measurement of serum insulin-like growth factor (IGF)-I levels.
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Assessment method [1]
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Timepoint [1]
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Week 14 compared to Baseline.
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Secondary outcome [2]
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To explore pharmacodynamic effects of ATL1103 on serum laboratory parameters (GH, GHBP, IGFBP-3, ALS, and IGF-II)
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Assessment method [2]
312100
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Timepoint [2]
312100
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Week 14 compared to Baseline
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Secondary outcome [3]
312101
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To explore pharmacodynamic effects of ATL1103 on ring size assessment using standard set of jewellers rings
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Assessment method [3]
312101
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Timepoint [3]
312101
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Week 14 compared to Baseline
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Secondary outcome [4]
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To explore pharmacodynamic effects of ATL1103 on Signs and Symptoms Scale
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Assessment method [4]
312102
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Timepoint [4]
312102
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Week 14 compared to Baseline
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Eligibility
Key inclusion criteria
- Provide written informed consent in accordance with local regulations.
- Are 18 to 80 years of age inclusive.
- Have acromegaly due to pituitary adenoma (micro or macro adenoma) identified by Magnetic Resonance Imaging (MRI).
- Have serum IGF-I level at Screening >1.3 times the upper limit of normal (ULN).
- Have nadir serum GH levels > 1ng/mL at all test time points within the 2 hours post oral glucose load for an oral glucose tolerance test (OGTT).
- Are acromegaly treatment naive, or who have not taken other acromegaly medications for a period of 6 weeks to 4 months, depending on the medication.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Have acromegaly due to reasons other than pituitary adenoma.
- Have participated in any clinical investigation with an investigational drug within 3 months (4 months if the drug is a new chemical entity) preceding the Baseline visit or during the washout period.
- Have a history of clinically relevant gastrointestinal, hepatic, renal, endocrine (other than acromegaly), haematological, metabolic, neurologic or psychiatric disease that in the investigator’s opinion may compromise their safety or effect results from this study.
- Have any other medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study, or are otherwise unsuitable for participation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/04/2015
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Actual
7/08/2015
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Date of last participant enrolment
Anticipated
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Actual
23/10/2015
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Date of last data collection
Anticipated
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Actual
23/09/2016
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Sample size
Target
4
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Antisense Therapeutics Limited
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Address [1]
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6 Wallace Avenue
Toorak Vic 3142
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Antisense Therapeutics Limited
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Address
6 Wallace Avenue
Toorak Vic 3142
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
289159
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Country [1]
289159
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Adelaide Hospital REC
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Ethics committee address [1]
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North Tce Adelaide 5000 SA
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Ethics committee country [1]
292130
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Australia
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Date submitted for ethics approval [1]
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05/11/2014
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Approval date [1]
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22/12/2014
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Ethics approval number [1]
292130
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HREC/14/RAH/499
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Summary
Brief summary
ATL1103 is being developed as a potential treatment for acromegaly, a disease of excessive growth hormone and insulin-like growth hormone (IGF-I) action. Approximately four acromegaly patients will receive 300mg ATL1103 twice a week for 13 weeks. All treatments will be administered by subcutaneous injection. The primary objectives of the study are to evaluate the safety and tolerability of a high dose of ATL1103, and to investigate the pharmacokinetic profiles of ATL1103. The effect of ATL1103 on serum IGF-I levels and on other pharmacodynamic markers will also be measured.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr David Torpy
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Address
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Royal Adelaide Hospital
North Tce
Adelaide 5000 SA
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Country
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Australia
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Phone
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+61 8 8222 5520
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Sue Turner
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Address
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Percheron Therapeutics Limited - L30, 35 Collins Street, Melbourne, Vic. 3000
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Country
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Australia
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Phone
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+61 3 9827 8999
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Andrew McKenzie
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Address
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Percheron Therapeutics Limited - L30, 35 Collins Street, Melbourne, Vic. 3000
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Country
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Australia
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Phone
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+61 3 9827 8999
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
RNA-Targeted Therapeutics
2018
https://doi.org/10.1016/j.cmet.2018.03.004
Embase
RNA Therapeutics: How Far Have We Gone?.
2019
https://dx.doi.org/10.1007/978-3-030-19966-1_7
Embase
Antisense drug discovery and development technology considered in a pharmacological context.
2021
https://dx.doi.org/10.1016/j.bcp.2020.114196
Embase
Overcoming the challenges of tissue delivery for oligonucleotide therapeutics.
2021
https://dx.doi.org/10.1016/j.tips.2021.04.010
N.B. These documents automatically identified may not have been verified by the study sponsor.
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