This study tests a new medicine (IMVT-1402) for adults with Graves’ disease to see if it is safe and works well, by comparing it to an inactive treatment.
This study is looking at whether a new medicine called IMVT-1402 is safe and can help adults with Graves’ disease whose overactive thyroid is not well controlled with current treatment. The medicine is given as a small injection under the skin using an easy-to-use device.
Anticipated enrolment close date: 30 November 2026
Who can take part
You may be eligible to participate if you:
- are 18-75 years of age
- have been formally diagnosed with Graves’ Disease, AND
- are able and willing to take part in the study for up to 35 weeks
- are on a stable dose of ATD for 4 weeks
You may not be eligible to participate if you:
- have previous radioactive iodine therapy or undergone total thyroidectomy
- not have any history of major cardiovascular, liver or eye disease
- are pregnant or breastfeeding
What's involved for you
Participants will be randomly assigned, with a 2:1 chance of receiving the treatment, given as a weekly injection for 26 weeks. There is also potential for participants to continue in a long-term extension study.
Study visits will include blood and urine collection and a medical assessment by the study team. Additional tests may include an ECG, blood pressure check, weight measurement, eye examination, thyroid ultrasound, and surveys.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by an Australian registered and certified HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2025). This statement protects the interests of people who agree to participate in human research studies.