How the Study Works
This study is a Phase 3 clinical trial taking place at multiple sites around the world. It is randomized and double-blind, meaning neither you nor your study doctor will know which treatment you receive during the study. This is the gold standard for clinical research and ensures reliable, unbiased results.
Your Study Journey (~30 weeks total)
SCREENING PHASE
Eligibility checks and baseline assessments.
TREATMENT
Participants receive treatment for 26 weeks.
FOLLOW-UP
Safety monitoring after treatment ends.
EXTENTION
Optional. Open-label continuation study for eligible completers.
How You Take It
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Delivered via auto-injector — similar to GLP-1
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First dose given at the study site with supervision
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All remaining doses can be self-administered at home
What We’re Measuring
- Whether TRAb (disease antibody) levels decrease
- Whether normal thyroid function is restored
- Whether antithyroid drug dose can be reduced or eliminated
- Overall safety and tolerability of BHV-1300
- Changes in total IgG antibody levels
Study Visits
- Regular clinic visits throughout the study
- Blood tests, physical exams and ECGs at visits
- Symptom questionnaires to track how you feel
- Ongoing safety monitoring by the study team
Your Medications During the Study
- You may continue antithyroid drugs (ATDs) during the study
- ATD doses will be adjusted as needed based on lab results
- Beta-blockers for symptom relief are also permitted
- The study team will guide all medication adjustments