A Phase II Randomised, Open-Label, Parallel Group Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Two Subcutaneous Dosing Regimens of ATL1103 in Adult Patients with Acromegaly.

Completed

• Conditions: Acromegaly; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12612000989842
• Lead Sponsor: Antisense Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability will be assessed by serum chemistry, haematology, urinalysis, physical exam, vital signs, electrocardiogram, MRI, and monitoring and recording adverse events[Over 13 weeks of treatment and 8 weeks of follow up];Single and multiple dose pharmacokinetic parameters[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.]

Secondary Outcome Measures

Name	Time	Method
Efficacy of ATL1103 will be assessed by measurement of serum insulin-like growth factor (IGF)-I levels.[Week 14 compared to Baseline.];To explore pharmacodynamic effects of ATL1103 on laboratory parameters (GH, GHBP, IGFBP-3, ALS, and IGF-II)[Week 14 compared to Baseline];To explore pharmacodynamic effects of ATL1103 on ring size assessment[Week 14 compared to Baseline];To explore pharmacodynamic effects of ATL1103 on Signs and Symptoms Scale[Week 14 compared to Baseline];To explore pharmacodynamic effects of ATL1103 on Acromegaly Quality-of-Life questionnaire[Week 14 compared to Baseline]