NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Graves Disease

In brief

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.

Key facts

Study ID

NCT07305818

Run by

Merida Biosciences

People needed

100

Starts

2025-12-19

Expected to finish

2028-07-24

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 to 65 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
• Willingness and ability, in the opinion of the investigator, to comply with protocol requirements and restrictions (eg, dosing, schedule of assessments).

You may not qualify if…

• 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.
• Current active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening
• History of TED-directed medical treatment (including IV/oral steroids, immunosuppressants, or teprotumumab), surgical treatment, and/or orbital radiation within 3 months prior to Screening, or per required prohibited concomitant therapy washout criteria in the protocol (whichever is longer)
• Major surgery or use of iodinated contrast within 3 months prior to planned IMP dosing.
• Active systemic autoimmune disease requiring treatment that causes undue risk in the opinion of the investigator.
• History of cardiovascular, respiratory, renal, gastrointestinal, endocrinological (other than GD), hematological, immunodeficiency, or neurological disorders that may constitute a risk when taking the IMP or interfere with data interpretation.
• History of liver disease
• Pregnant, breastfeeding, or planning to become pregnant during the study
• Treatment with prohibited medications prior to planned IMP dosing or likely to require prohibited concomitant therapy during the study
• Live vaccine(s) or mRNA vaccine(s) within 1 month prior to IMP dosing, or plans to receive such vaccines during the study
• Treatment with any investigational drug within within 3 months or 5 half-lives (whichever is longer) prior to enrollment
• Total IgG level <700 mg/dL at Screening
• Any of the following at Screening (confirmed by single repeat measurement, if deemed necessary):
• ALT or AST >1.5 × ULN
• Total bilirubin >1.5 × ULN
• Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
• Positive result for HIV antibody, HBsAg, or hepatitis C antibody with detectable viral RNA levels at Screening
• Positive drug screen or positive test for alcohol
• 12-lead ECG demonstrating any of the following at Screening:

Where it is running

• Site # 1101 — Hollywood, Florida, United States (enrolling)
• Site # 1112 — Miami, Florida, United States (enrolling)
• Site # 1109 — Wesley Chapel, Florida, United States (enrolling)
• Site # 1107 — Boston, Massachusetts, United States (enrolling)
• Site # 1102 — Rochester, Minnesota, United States (enrolling)
• Site # 1104 — Columbus, Ohio, United States (enrolling)
• Site # 1108 — Philadelphia, Pennsylvania, United States (enrolling)
• Site # 1105 — Webster, Texas, United States (enrolling)
• Site # 2201 — Seville, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.