A Phase II Open-Label Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ATL1103 300mg in Adult Patients with Acromegaly.

Phase 2

Completed

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

• Registration Number: ACTRN12615000289516
• Lead Sponsor: Antisense Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-27
• Study Completion: 2016-09-23
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3

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