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NEXUS Study: MER511 for Graves' Disease

This study, called NEXUS, is testing a new treatment called MER511 for adults with Graves' disease. Researchers want to see how safe MER511 is and what side effects it might cause. You would receive MER511 or a placebo (an inactive substance) either through a vein (intravenously) or under the skin (subcutaneously). The study will also look at how your body handles MER511 and how it affects your body. To join, you need to be between 18 and 55 years old, have a Graves' disease diagnosis, and be on a stable dose of antithyroid medication. The main goals are to track any side effects and changes in your health, like heart rhythm or blood tests, for up to 24 weeks. The current status of the study is unclear.

Study design
This is a Phase 1 study, meaning it's one of the first times MER511 is being tested in humans. It will involve about 100 participants and is designed so that neither you nor your doctor will know if you are receiving MER511 or a placebo.
What's involved
You would receive doses of MER511 or placebo on Day 1, and some participants would also receive a dose on Day 29. Blood tests will be performed to understand how your body processes the study drug.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for side effects and changes for up to 16 weeks in one part of the study, and up to 24 weeks in another part.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07305818

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Merida Biosciences
~100 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:MER511 (IV)Placebo comparator (IV)MER511 (SC)Placebo comparator (SC)MER511 (SC) for MADPlacebo comparator (SC) for MAD

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with TEAEs (Treatment-emergent adverse events)
Measured over - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
+1 more outcome measured

Conditions

Graves Disease

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Graves Disease

NCT07305818

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Site # 1101

    Hollywood, Floridastudy coordinator listed

    Recruiting

  • Site # 1102

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Site # 1104

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • Site # 1105

    Webster, Texasstudy coordinator listed

    Recruiting

  • Site # 1106

    Morehead City, North Carolinastudy coordinator listed

    Recruiting

  • Site # 1107

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Site # 1108

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Site # 1109

    Wesley Chapel, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Clinical Operations
[email protected]
+1 339-255-3030
Email the study team

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Eligibility criteria

Exclusion

ALT or AST \>1.5 × ULN
Total bilirubin \>1.5 × ULN 16. Estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 17. Positive result for HIV antibody, HBsAg, or hepatitis C antibody with detectable viral RNA levels at Screening 18. Positive drug screen or positive test for alcohol 19. 12-lead ECG demonstrating any of the following at Screening:
QTcF interval \>450 ms
QRS interval \>120 ms
PR interval \>220 ms 20. Blood pressure measurements demonstrating any of the following at Screening:
Systolic blood pressure ≥140 mmHg
Diastolic blood pressure ≥90 mmHg 21. Heart rate \<45 bpm or \>100 bpm 22. Donated more than 500 mL of blood in the 2 months prior to signing the ICF 23. Current enrollment or past participation within 3 months or 5 half-lives (whichever is longer) prior to signing the ICF in any other clinical trial involving an IMP 24. Refusal to adhere to lifestyle considerations as defined in the protocol 25. Employee of the investigator, clinic, or sponsor with direct involvement in the proposed study or other studies under the direction of the investigator or clinic, as well as family members of the employee or investigator 26. Any other conditions that, in the opinion of the investigator or the sponsor, could interfere with participation in or completion of the study

What this trial measures

  • Number of participants with TEAEs (Treatment-emergent adverse events)- Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24

    Adverse events that start or worsen in severity after the start of study drug will be categorized as TEAEs

  • Number of participants with clinically significant changes in ECGs, vital signs, clinical laboratory values, and physical examination- Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24

    Incidence of clinically significant abnormalities in ECGs, vital signs, clinical laboratory values, and physical examination