MER511 for Graves' Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called MER511 for individuals with Graves' disease, an autoimmune condition affecting the thyroid. The study will assess how well the body tolerates the drug and identify any potential side effects. Participants will receive the medication either intravenously (IV) or subcutaneously (SC), and researchers will conduct blood tests to observe the drug's interaction with the body. Individuals diagnosed with Graves' disease who are on a stable dose of antithyroid medication might be suitable candidates for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial requires participants to be on a stable dose of antithyroid drugs (ATD) and prohibits the use of certain medications like levothyroxine within 6 weeks prior to screening. It does not specify if you need to stop other medications, so it's best to discuss your current medications with the study team.
Is there any evidence suggesting that MER511 is likely to be safe for humans?
Research shows that MER511 has been safe in both lab and animal studies. These studies are crucial steps before human testing and suggest that MER511 is generally well-tolerated. Although specific data from human trials is not yet available, earlier results are promising. As this is an early-phase trial, the main goal is to assess how well participants tolerate the treatment and to identify any side effects. This trial aims to provide more information about the safety of MER511 for people with Graves' disease.12345
Why do researchers think this study treatment might be promising for Graves' disease?
Most treatments for Graves' disease, like antithyroid medications, work by interfering with the production of thyroid hormones. But MER511 is unique because it targets the underlying autoimmune response that causes the disease, potentially addressing the root cause rather than just managing symptoms. Researchers are excited about MER511 because it offers a new mechanism of action and could lead to more effective and lasting relief for patients. Additionally, MER511 is being tested with both intravenous (IV) and subcutaneous (SC) delivery methods, providing flexibility in how it can be administered, which might improve patient comfort and adherence.
What evidence suggests that MER511 might be an effective treatment for Graves' disease?
Research shows that MER511 targets and neutralizes specific disease processes in autoimmune conditions like Graves' disease. Although detailed human data on its effectiveness for Graves' disease remains limited, this treatment is being developed as a potentially first-of-its-kind option, offering a novel approach to addressing the disease. Early results from similar treatments show promise in managing symptoms, but specific outcomes for MER511 in Graves' disease are still under investigation. Participants in this trial will receive either MER511 or a placebo to help determine how the drug is processed by the body and its effect on disease symptoms.12678
Are You a Good Fit for This Trial?
Adults aged 18-55 with Graves' disease, weighing at least 50 kg and a BMI of 18.0-35.0 can join this study if they've signed the consent form and can follow the study plan. They must be on a stable dose of antithyroid drugs, and men and women must agree to use contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD) Treatment
Participants receive single ascending doses of MER511 via IV or SC administration
Multiple Ascending Dose (MAD) Treatment
Participants receive multiple ascending doses of MER511 via SC administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MER511
Trial Overview
The NEXUS Study is testing MER511 for treating Graves' disease by giving it either as an injection under the skin or directly into a vein. Participants will also receive placebo treatments for comparison, and researchers will monitor how their bodies react to MER511.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Up to 3 cohorts of participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29
For Cohort 8, participants will receive a single dose of MER511 (determined from Cohort 1-7) via SC administration on Day 1
For Cohorts 1-7 , each cohort participant will receive a single ascending dose of MER511 via IV administration on Day 1
For Cohorts 1-7, each cohort participant will receive a single dose of placebo via IV administration on Day 1
For Cohort 8, participants will receive a single dose of placebo (determined from Cohort 1-7) via SC administration on Day 1
Up to 3 cohorts of participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merida Biosciences
Lead Sponsor
Citations
A STUDY TO TEST SINGLE AND MULTIPLE DOSES OF ...
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.
MER511 for Graves' Disease · Info for Participants
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.
Outcomes of Patients With Graves Disease 25 Years After ...
We included 83% (182/218) of the patients from the original study. At the end of follow-up, normal thyroid function was achieved in 34%. The ...
4.
thyroid.org
thyroid.org/patient-thyroid-information/ct-for-patients/february-2024/vol-17-issue-2-p-7-8/Long term outcomes of patients with Graves' Disease
Among the 78 patients (43%) who achieved remission after the initial study, 62% had normal thyroid homone levels in the long term follow-up, with 14% having ...
Merida Biosciences Launches with $121M to Create ...
Merida is developing a potentially first-in-class and best-in-class treatment to precisely target, neutralize and eliminate these disease ...
OR31-05 Specific and Deep Depletion of anti-TSHR ...
Graves' Disease (GD) and Thyroid Eye Disease (TED) are caused by ... In vitro and in vivo toxicology studies have shown a safe profile for MER511 ...
7.
linkedin.com
linkedin.com/posts/merida-biosciences_dario-gutierrezs-journey-to-founding-merida-activity-7368627810845741071-QwtBDario Gutierrez's Journey to Founding Merida Biosciences
Within our pipeline, we are first advancing MER511 for Graves' disease, with plans to expand further into other autoimmune conditions.
Prospectively recorded and MedDRA-coded safety data of ...
Safety of intravenous (IV) steroid pulses in patients with Graves' orbitopathy (GO) is still controversial while steroid dose and treatment application have ...
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