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New drug aims to tame overactive thyroid in Graves' disease

NCT ID NCT07661056

Disease control Sponsor: Biohaven Therapeutics Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 26 times

Summary

This study tests whether BHV-1300 can help adults with Graves' disease achieve normal thyroid function without antithyroid drugs. Participants receive either BHV-1300 or a placebo via injection. The main goal is to see if more people on BHV-1300 have normal thyroid hormone levels at 26 weeks.

What this could mean

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

Active substance
BHV-1300
What this could lead to
If successful, BHV-1300 could offer a new treatment option for Graves' disease that helps patients achieve normal thyroid function without needing antithyroid drugs.
What could go wrong
This is an early phase 3 trial, so results may not confirm benefit. The drug may cause side effects or fail to outperform placebo. Long-term safety and efficacy are not yet established.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

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

Started

Jun 2026

Expected to finish

Feb 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 70 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.

Key Inclusion Criteria: 1. Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies 2. Participants must have active hyperthyroidism due to Graves' disease Key Exclusion Criteria: 1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) 2. History of treatment with radioactive iodine or thyroid surgery. 3. Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit. 4. Thyroid storm, i.e. severe thyrotoxicosis with evidence of systemic decompensation (e.g., Burch-Wartkofsky Point Scale of ≥ 45 or Japanese Thyroid Association category 1 or 2, with accompanying manifestations including hyperpyrexia, tachycardia, arrhythmias, congestive heart failure, agitation, delirium, psychosis, stupor, and coma, as well as nausea, vomiting, diarrhea, or hepatic failure) within 6 weeks of Screening. 5. Have autoimmune disease other than Graves' disease requiring treatment 6. Have moderate to severe thyroid eye disease (TED) or are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation. 7. Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout 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

    50 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Site-004

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Site-006

    RECRUITING

    San Diego, California, 92108, United States

  • Site-008

    RECRUITING

    Canton, Ohio, 44718, United States

  • Site-009

    RECRUITING

    Weslaco, Texas, 78596, United States

  • Site-010

    RECRUITING

    North Charleston, South Carolina, 29406, United States

  • Site-011

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Site-013

    RECRUITING

    Layton, Utah, 84041, United States

  • Site-015

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Site-016

    RECRUITING

    Chattanooga, Tennessee, 37411, United States

  • Site-017

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Site-019

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Site-020

    RECRUITING

    Dallas, Texas, 75246, United States

  • Site-025

    RECRUITING

    Lenexa, Kansas, 66234, United States

  • Site-027

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Site-029

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Site-031

    RECRUITING

    Champaign, Illinois, 61822, United States

  • Site-032

    RECRUITING

    Burbank, California, 91501, United States

  • Site-033

    RECRUITING

    Statesville, North Carolina, 28625, United States

  • Site-034

    RECRUITING

    Houston, Texas, 77040, United States

  • Site-036

    RECRUITING

    Shavano Park, Texas, 78231, United States

  • Site-037

    RECRUITING

    Norman, Oklahoma, 73072, United States

  • Site-038

    RECRUITING

    Asheville, North Carolina, 28803, United States

  • Site-039

    RECRUITING

    Raleigh, North Carolina, 27612, United States

  • Site-042

    RECRUITING

    El Paso, Texas, 79935, United States

  • Site-043

    RECRUITING

    Denton, Texas, 76210, United States

  • Site-044

    RECRUITING

    Tucson, Arizona, 85741, United States

  • Site-045

    RECRUITING

    Wilmington, North Carolina, 28405, United States

  • Site-046

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Site-048

    RECRUITING

    Oakland, California, 94611, United States

  • Site-052

    RECRUITING

    Doral, Florida, 33172, United States

  • Site-053

    RECRUITING

    Fayetteville, Georgia, 30214, United States

  • Site-054

    RECRUITING

    McKinney, Texas, 75069, United States

  • Site-055

    RECRUITING

    Dallas, Texas, 75231, United States

  • Site-057

    RECRUITING

    San Antonio, Texas, 78251, United States

  • Site-059

    RECRUITING

    Palm Beach Gardens, Florida, 33410, United States

  • Site-060

    RECRUITING

    San Juan, 00909, Puerto Rico

  • Site-061

    RECRUITING

    Miami, Florida, 33010, United States

  • Site-062

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Site-063

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Site-064

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Site-066

    RECRUITING

    Fort Myers, Florida, 33919, United States

  • Site-067

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Site-070

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • Site-071

    RECRUITING

    Houston, Texas, 77058, United States

  • Site-072

    RECRUITING

    Las Vegas, Nevada, 89148, United States

  • Site-073

    RECRUITING

    Midlothian, Virginia, 23112, United States

  • Site-074

    RECRUITING

    Tampa, Florida, 33634, United States

  • Site-076

    RECRUITING

    Seattle, Washington, 98104, United States

  • Site-080

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Site-081

    RECRUITING

    Amarillo, Texas, 79124, United States

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