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New drug AMG 732 aims to reduce eye bulging in thyroid eye disease

NCT ID NCT06401044

Disease control Sponsor: Amgen 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 4 times

Summary

This study tests a new drug called AMG 732 for people with moderate-to-severe active thyroid eye disease, a condition that causes eye bulging and discomfort. The trial has two parts: Part A checks safety in healthy volunteers, and Part B tests how well the drug works in patients. Researchers will measure changes in eye protrusion and monitor for side effects.

What this could mean

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

Active substance
AMG 732 (an injectable drug)
What this could lead to
If it works, this could lead to a new treatment option that reduces eye bulging and other symptoms of thyroid eye disease.
What could go wrong
This is an early-phase trial with only 88 participants, so results may not apply to everyone. The drug may cause side effects or fail to show benefit.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

94 people

The number who actually took part.

Started

May 2024

Expected to finish

Dec 2027

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 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for Part A/Phase 1 only: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Male or female aged 18 to 55 years (Part A). * Female participants must be of non-childbearing potential. * Body mass index (BMI) between 18 and 30 kg/m\^2, inclusive, at screening. * The participant has adequate venous access and can receive intravenous (IV) therapy. * The participant is considered by the investigator or designee to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening. * Healthy Japanese participants in cohort 4 only. Japanese participants must meet all the following as confirmed by interview: Descendants of 4 ethnic Japanese grandparents who were born in Japan; Both parents are ethnic Japanese who were born in Japan; Hold a Japanese passport or identity papers; Have lived outside Japan for less than 10 years at the time of screening and lifestyle including diet has not changed significantly since leaving Japan. Inclusion criteria for Part B/Phase 2 only: * Male or female aged 18 to 65 years. * Moderate-to-severe active TED. * The participant had onset of active TED within 15 months prior to baseline. * Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS)≥3 for the most severely affected eye at screening and baseline. * Proptosis ≥18mm in the study eye at baseline. * Participants with baseline subjective binocular diplopia score \>0. * Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial. Exclusion criteria for Part A and Part B: * Malignant condition in the past 12 months or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study. * Active liver or kidney disfunction at screening. * Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening. * Glycated hemoglobin (HbA1c) \> 6.5% and/or fasting glucose levels\> 126 mg/dL (\> 7 mmol/L) at screening. * Use of any steroid (IV, oral, steroid eye drops) within 3 weeks prior to the first dose. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat injection related reactions or short course of steroid for asthma control. * Known hypersensitivity to teprotumumab or any other monoclonal antibody products. * History of substance abuse within 12 months before screening. * Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing. Exclusion criteria for PartA/Phase 1 only • Blood pressure or ECG abnormalities at screening. Exclusion criteria for Part B/Phase 2 only: * Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug. * Use of teprotumumab or any other IGF-1R inhibitor. * Prior orbital irradiation or decompression in the study eye. * History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease). Other protocol-defined inclusion/exclusion criteria apply.

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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.

Thyroid eye disease

Contacts and locations

Locations

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi-ken, 480-1195, Japan

  • Amy Patel Jain MD

    Newport Beach, California, 92660, United States

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205, United States

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Socio Sanitaria Territoriale dei Sette Laghi

    Varese, 21100, Italy

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030, United States

  • Buergerhospital und Clementine Kinderhospital gGmbH

    Frankfurt am Main, 60318, Germany

  • CHU de Québec-Université Laval - CUO-Recherche Clinique, Hopital du Saint-Sacrement

    Québec, Quebec, G1S 4L8, Canada

  • Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

    Nantes, 44800, France

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa

    Swidnica, 58-100, Poland

  • Eb Group Spolka z ograniczona odpowiedzialnoscia

    Warsaw, 00-189, Poland

  • Erie Retina Research

    Erie, Pennsylvania, 16505, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • General Hospital of Athens Laiko

    Athens, 11527, Greece

  • Hayashi Eye Hospital

    Fukuoka, Fukuoka, 812-0011, Japan

  • Hopital Pitie-Salpetriere

    Paris, 75013, France

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009, Spain

  • Ilumina Medical Research

    Kissimmee, Florida, 34744, United States

  • Ippokratio General Hospital of Thessaloniki

    Thessaloniki, 54642, Greece

  • Kozawa Eye Hospital And Diabetes Center

    Mito, Ibaraki, 310-0845, Japan

  • Levenson Eye Associates

    Jacksonville, Florida, 32204, United States

  • Macquarie University

    North Ryde, New South Wales, 2109, Australia

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114, United States

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • North Shore Private Hospital

    St Leonards, New South Wales, 2065, Australia

  • Ppd Las Vegas Research Unit

    Las Vegas, Nevada, 89113, United States

  • Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

    Gdansk, 80-180, Poland

  • Santé Québec Est-de-l'Île-de-Montréal - Universitaire

    Montreal, Quebec, H1T 2M4, Canada

  • Sarasota Retina Institute

    Sarasota, Florida, 34239, United States

  • Singapore National Eye Centre

    Singapore, 169608, Singapore

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04013, Germany

  • University of Miyazaki Hospital

    Miyazaki, Miyazaki, 889-1692, Japan

  • Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spzoo

    Poznan, 60-354, Poland

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 0A6, Canada

  • Vision Medical Research, Inc.

    Orland Park, Illinois, 60462, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

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