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New drug MER511 enters first human trial for Graves' disease

NCT ID NCT07305818

Disease control Sponsor: Merida Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 25, 2026 · Updated 9 times

Summary

This early-stage trial tests a new biologic drug called MER511 in 100 adults with Graves' disease. The main goal is to check safety and side effects, and to see how the body handles the drug when given by IV or injection. Participants must be on stable thyroid medication. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MER511 (a biologic drug given by IV or injection under the skin)
What this could lead to
If successful, this could point toward a new treatment option for Graves' disease that helps control the condition with fewer side effects.
What could go wrong
This is a very early Phase 1 trial focused on safety, so it is not yet known if MER511 works. Side effects are possible, and the drug may not prove effective in later studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults 18 to 65 years of age, inclusive, at the time of signing the ICF 2. Documented GD diagnosis, 3. Receiving stable dose of ATD (Antithyroid drug) 4. Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive 5. Women of childbearing potential must agree to use highly effective contraceptive methods 6. Men with partners of childbearing potential or who are pregnant must agree to use a condom or strict abstinence 7. Signed informed consent to participate in the study 8. Willingness and ability, in the opinion of the investigator, to comply with protocol requirements and restrictions (eg, dosing, schedule of assessments). Exclusion Criteria: 1. History of: 1. total thyroidectomy. 2. History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter). 3. History of thyroid storm. 4. 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 2. Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis. 3. Use of levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks prior to Screening. 4. Current active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening 5. 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) 6. Major surgery or use of iodinated contrast within 3 months prior to planned IMP dosing. 7. Active systemic autoimmune disease requiring treatment that causes undue risk in the opinion of the investigator. 8. 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. 9. History of liver disease 10. Pregnant, breastfeeding, or planning to become pregnant during the study 11. Treatment with prohibited medications prior to planned IMP dosing or likely to require prohibited concomitant therapy during the study 12. Live vaccine(s) or mRNA vaccine(s) within 1 month prior to IMP dosing, or plans to receive such vaccines during the study 13. Treatment with any investigational drug within within 3 months or 5 half-lives (whichever is longer) prior to enrollment 14. Total IgG level \<700 mg/dL at Screening 15. 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 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

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Conditions

The condition(s) this trial relates to.

Graves disease hyperthyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graves disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Site # 1101

    RECRUITING

    Hollywood, Florida, 33024, United States

    Contact Email: •••••@•••••

  • Site # 1102

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • Site # 1104

    RECRUITING

    Columbus, Ohio, 43203, United States

    Contact Email: •••••@•••••

  • Site # 1105

    RECRUITING

    Webster, Texas, 77598, United States

    Contact Email: •••••@•••••

  • Site # 1106

    RECRUITING

    Morehead City, North Carolina, 28557, United States

    Contact Email: •••••@•••••

  • Site # 1107

    RECRUITING

    Boston, Massachusetts, 02114, United States

    Contact Email: •••••@•••••

  • Site # 1108

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

    Contact Email: •••••@•••••

  • Site # 1109

    RECRUITING

    Wesley Chapel, Florida, 33544, United States

    Contact Email: •••••@•••••

  • Site # 1111

    RECRUITING

    Torrance, California, 90502, United States

    Contact Email: •••••@•••••

  • Site # 1112

    RECRUITING

    Miami, Florida, 33125, United States

    Contact Email: •••••@•••••

  • Site # 1113

    RECRUITING

    DeSoto, Texas, 75115, United States

    Contact Email: •••••@•••••

  • Site # 2201

    RECRUITING

    Seville, 41009, Spain

    Contact Email: •••••@•••••

  • Site # 2204

    RECRUITING

    Barcelona, 08017, Spain

    Contact Email: •••••@•••••

  • Site # 2205

    RECRUITING

    A Coruña, 15006, Spain

    Contact Email: •••••@•••••

  • Site # 2206

    RECRUITING

    Barcelona, 08023, Spain

    Contact Email: •••••@•••••

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