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NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
Led by Merida Biosciences · Updated on 2026-04-24
100
Participants Needed
7
Research Sites
135 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 55 years at the time of consent
- Diagnosed with Graves' disease
- Receiving a stable dose of antithyroid drug
- Body weight at least 50 kg and BMI between 18.0 and 35.0
- Women of childbearing potential agree to use highly effective contraception
- Men with partners of childbearing potential or who are pregnant agree to use condom or abstinence
- Signed informed consent
- Willing and able to comply with study requirements and restrictions
You will not qualify if you...
- History of total thyroidectomy
- History of hyperthyroidism not due to Graves' disease
- History of thyroid storm
- History of agranulocytosis, anemia, leukopenia, thrombocytopenia, vasculitis, or liver toxicity from prior antithyroid drug therapy
- Treatment with radioactive iodine therapy within 12 months before screening
- Likely to need definitive treatment for Graves' disease during the study
- Use of levothyroxine, desiccated thyroid extract, or T3 within 6 weeks before screening
- History of moderate-to-severe thyroid eye disease
- History of thyroid eye disease treatments including steroids, immunosuppressants, surgery, or radiation
- Major surgery or use of iodinated contrast within 3 months before dosing
- Active autoimmune disease requiring risky treatment
- History of cardiovascular, respiratory, kidney, gastrointestinal, endocrine (other than Graves'), blood, immune, or neurological disorders posing risk or interfering with data
- History of liver disease
- Pregnant, breastfeeding, or planning pregnancy during study
- Use of prohibited medications before or during study
- Recent live or mRNA vaccines within 1 month before dosing or planned during study
- Treatment with investigational drug within 6 months before enrollment
- Low total IgG level at screening
- Elevated liver enzymes or bilirubin at screening
- Low kidney function at screening
- Positive HIV, hepatitis B, or hepatitis C tests with viral activity
- Positive drug or alcohol screen
- ECG abnormalities at screening
- High blood pressure or abnormal heart rate at screening
- Recent blood donation exceeding 500 mL within 2 months
- Participation in another investigational study recently
- Refusal to follow lifestyle guidelines
- Employment or family relation to study staff
- Any other condition interfering with study participation
- For Part B only: prior receipt of study drug in Part A
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Site # 1103
Phoenix, Arizona, United States, 85053
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2
Site # 1101
Hollywood, Florida, United States, 33024
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3
Site # 1107
Boston, Massachusetts, United States, 02114
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4
Site # 1102
Rochester, Minnesota, United States, 55905
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5
Site # 1104
Columbus, Ohio, United States, 43203
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6
Site # 1108
Philadelphia, Pennsylvania, United States, 19107
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7
Site # 1105
Webster, Texas, United States, 77598
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Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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