NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Dis… (NCT07305818) | Clinical Trial Compass
RecruitingPhase 1
NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
United States100 participantsStarted 2025-12-19
Plain-language summary
The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults 18 to 55 years of age, inclusive, at the time of signing the ICF
. Documented GD diagnosis,
. Receiving stable dose of ATD (Antithyroid drug)
. Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive
. Women of childbearing potential must agree to use highly effective contraceptive methods
. Men with partners of childbearing potential or who are pregnant must agree to use a condom or strict abstinence
. Signed informed consent to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with TEAEs (Treatment-emergent adverse events)
Timeframe: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
2
Number of participants with clinically significant changes in ECGs, vital signs, clinical laboratory values, and physical examination
Timeframe: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
. Willingness and ability, in the opinion of the investigator, to comply with protocol requirements and restrictions (eg, dosing, schedule of assessments).
Exclusion criteria
. History of:
. total thyroidectomy.
. History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter).
. History of thyroid storm.
. History of agranulocytosis, anemia, leukopenia, thrombocytopenia, vasculitis, or liver toxicity due to prior ATD therapy Treatment with RAI therapy within 12 months prior to Screening
. Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis.
. Use of levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks prior to Screening.
. History of active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening