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Experimental K9 pill tested for thyroid eye disease – but study stopped early

NCT ID NCT06467435

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase trial tested an oral drug called K9 (kamuvudine-9) in people with thyroid eye disease, a condition that causes eye bulging and discomfort. The study planned to enroll up to 10 patients but was terminated after only 4 participants. The main goal was to check safety, not to prove the drug works.

What this could mean

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

Active substance
Kamuvudine-9 (K9) tablets
What this could lead to
If it works, this could point toward a new oral treatment to control thyroid eye disease symptoms.
What could go wrong
This was a very small, early-phase safety study that was terminated early, so we have little data on effectiveness. The results may not apply to a larger population.

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

4 people

The number who actually took part.

Started

Nov 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 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: Cohort 1 * Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol Cohort 2 * Diagnosed with Thyroid Eye Disease (TED). * Symptomatic TED diagnosed no more than 9 months earlier. * Clinical Activity Score ≥ 3 (on 7 point scale) for the worse eye. * Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol. Exclusion Criteria: Cohort 1 * Body weight less than 55 kg. * History of any clinically significant medical disorders the principal investigator considers exclusionary, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease. * Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception. * History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator. * Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary Cohort 2 * Body weight less than 55 kg. * Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception. * History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator. * Participation in any investigational drug or ocular device study within 30 days prior to the Day 1 Study Visit. * History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study. * Participation in any systemic experimental treatment or any other systemic investigational new drug within 5 half-lives of the active ingredient prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary. * History of use of teprotumumab (Tepezza), radiotherapy, or orbital surgery. * History (last 6 weeks) of use of systemic immunosuppressants (e.g. mycophenolate), intravenous immunoglobulin, or plasmapheresis. * Clinical activity score \< 3 * Uncontrolled diabetes or hypertension * History of mental / psychiatric disorder * Hepatic dysfunction (Albumin (Alb), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility) * Renal impairment (Urea, Creatinine, and Glomerular Filtration Rate levels must be within normal range) * Any baseline condition that the principal investigator considers exclusionary.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.