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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000289516

Enrollment

Registered

2015-03-27

Start date

2015-08-07

Completion date

2015-10-23

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

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.

Outcome results