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New drug shows promise for bulging eyes in thyroid disease

NCT ID NCT06226545

Disease control Sponsor: Lassen Therapeutics Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new medicine called LASN01 in 41 adults with thyroid eye disease, a condition that causes eye bulging and discomfort. The goal was to see if LASN01 could safely reduce eye bulging compared to a placebo. Participants received either LASN01 or a dummy treatment by IV, and researchers measured changes in eye position and side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

41 people

The number who actually took part.

Started

Mar 2024

Finished

Apr 2025

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 years and older

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. Male or female patients ≥18 years of age at the time of Screening 2. Clinical diagnosis of Graves' disease associated with active TED 3. Moderate-to-severe active TED 4. Female patients must be nonpregnant, nonlactating, surgically sterile for ≥6 months, or agree to use a highly effective method of contraception. Males must be surgically sterile or agree to use a highly effective method of contraception. 5. No previous: 1. Medical treatment for TED, with the exception of: * Local supportive measures; * Mycophenolate, and oral or injectable steroids; * Immunomodulating therapies * For the open-label treatment arm only: Previous treatment with teprotumumab is required. 2. Orbital surgery 3. Orbital radiation 6. Patients * Without prior anti-IGF-1R treatment: less than 15 months from onset of TED symptoms * With prior teprotumumab treatment: depending on time of diagnosis or reactivation of disease Exclusion Criteria: 1. Patients with 2 mm proptosis decrease between Screening and Day 1, or a 1-point decrease on the CAS 7-point scale between Screening and Day 1 2. Patients with a known decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 3 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months before Screening; or any known optic neuropathy or compression or any neurologic or neuro-ophthalmologic condition that may result in visual field loss. 3. Previous or any planned orbital irradiation/radiotherapy or orbital surgery for TED during the study period (ie, treatment and FU) 4. Use of oral and/or IV corticosteroid for conditions other than TED in the 6 weeks before Day 1 (topical steroids for conditions other than TED are allowed) 5. Active autoimmune disorder(s) requiring or likely to require treatment (other than Grave's disease and TED) that would interfere with study assessments, as determined by the PI or designee 6. Any previous use of anti-IGF-1R monoclonal antibody (eg, teprotumumab) at any time, with exception to the open-label post-teprotumumab treatment arm where prior use of teprotumumab is required 7. Use of selenium within 3 weeks before Day 1 or expected use during the clinical trial (multivitamins that include selenium are allowed in usual doses) 8. Use or expected use of biotin (including multivitamins that include biotin) within 2 days before any laboratory collection

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Conditions

The condition(s) this trial relates to.

disease of orbital part of eye adnexa endocrine exophthalmos endocrine system disorder exophthalmos eye disorder Graves Ophthalmopathy

As listed by the trial registrant

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

Endocrine system diseases Eye diseases Graves ophthalmopathy Graves' orbitopathy Orbital diseases Proptosis Thyroid associated ophthalmopathy Thyroid eye disease

Contacts and locations

Locations

  • Site 101

    San Diego, California, 92093, United States

  • Site 103

    Miami, Florida, 33136, United States

  • Site 104

    Houston, Texas, 77401, United States

  • Site 105

    Palo Alto, California, 94303, United States

  • Site 106

    Houston, Texas, 77030, United States

  • Site 108

    Livonia, Michigan, 48152, United States

  • Site 109

    Seattle, Washington, 98104, United States

  • Site 110

    Wilmington, North Carolina, 28403, United States

  • Site 111

    Beverly Hills, California, 90210, United States

  • Site 112

    Las Vegas, Nevada, 89144, United States

  • Site 201

    London, EC1V 2PD, United Kingdom

  • Site 204

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Site 206

    London, NW1 5QH, United Kingdom

  • Site 301

    Seville, 41009, Spain

  • Site 302

    Córdoba, 14012, Spain

More trials for these conditions

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