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Study of AMG 732 injection compared to placebo in patients with moderate to severe thyroid eye disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Thyroid Eye Disease, a condition that affects the eyes and surrounding tissues, causing symptoms like eye bulging, tissue swelling, and double vision. The study will test a new medication called AMG 732, which is given as an injection under the skin (subcutaneous injection). Some participants will receive AMG 732 while others will receive placebo.

The purpose of this research is to investigate how well AMG 732 works in people with moderate to severe active Thyroid Eye Disease. The study will include both healthy volunteers and people with Thyroid Eye Disease. The medication or placebo will be given multiple times during the study to evaluate its effects on eye symptoms.

During the study, doctors will monitor changes in eye bulging (also called proptosis), eye movement, and vision. They will also track how the medication moves through the body and check for any side effects. Participants will complete questionnaires about their vision-related quality of life and appearance throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be assessed based on specific criteria, including your age (18-65 years) and diagnosis of Thyroid Eye Disease (TED).

    The study requires that your TED symptoms started within 15 months before the study begins.

    Your condition must be moderate-to-severe active TED with at least two symptoms such as lid retraction, soft tissue involvement, eye protrusion, or double vision.

  2. Step 2

    Baseline measurements

    Your eye measurements will be taken, including proptosis (eye protrusion), which must be at least 18 mm in the study eye.

    Your thyroid function will be checked to ensure it is either normal or only mildly abnormal.

    Your quality of life related to vision and appearance will be evaluated through questionnaires.

  3. Step 3

    Treatment administration

    You will receive either AMG 732 or a placebo (salt water solution) through subcutaneous injection (injection under the skin).

    The study is double-masked, meaning neither you nor the medical staff will know which treatment you are receiving.

  4. Step 4

    Monitoring and follow-up

    Your eye measurements will be regularly checked to track changes in proptosis.

    Blood samples will be taken to measure drug levels and check for antibodies against the medication.

    Any side effects or adverse reactions will be documented throughout the study.

    Your quality of life will be reassessed using the same questionnaires as at the beginning.

  5. Step 5

    Study completion

    The study is expected to continue until August 2027.

    Final assessments will include eye measurements, quality of life evaluation, and safety checks.

Who can join the trial?

9 criteria

  • You must provide informed consent before any study procedures begin
  • Your age must be: - Between 18-55 years for Part A of the study - Between 18-65 years for Part B of the study
  • For Part B participants, you must have moderate to severe active Thyroid Eye Disease with at least 2 of these conditions: - Eyelid retraction of 2mm or more - Moderate or severe soft tissue swelling - Eye protrusion of 3mm or more - Double vision that comes and goes or is constant
  • For Part B, your Thyroid Eye Disease symptoms must have started within the last 15 months
  • For Part B, you must have active Thyroid Eye Disease with a Clinical Activity Score (CAS) of 3 or higher in your most affected eye
  • For Part B, your eye protrusion must measure 18mm or more in the study eye
  • For Part B, you must experience some degree of double vision
  • For Part B, your thyroid levels must be: - Normal, or - Slightly above or below normal (within 50% of normal range)
  • For Part B, you must not: - Need immediate eye surgery - Plan to have eye surgery during the study - Plan to have radiation treatment during the study

Who cannot join the trial?

14 criteria

  • History of radioactive iodine treatment (a treatment that uses radioactive material to treat thyroid conditions) within 3 months before starting the study
  • Recent orbital surgery (surgery around the eye area) or plan to have it during the study
  • Active bacterial or viral eye infections
  • Previous treatment with orbital radiation therapy (using radiation to treat the eye area)
  • Severe uncontrolled high blood pressure
  • History of cancer within the past 5 years
  • Current pregnancy or breastfeeding
  • Participation in another clinical trial within 30 days
  • Serious or unstable medical conditions that could interfere with the study
  • Known allergic reactions to similar medications
  • Current use of medications that could interact with the study drug
  • Inability to follow study procedures or attend scheduled visits
  • History of drug or alcohol abuse within the past year
  • Significant eye problems unrelated to Thyroid Eye Disease
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Investigated drugs

AMG 732 is an investigational medication being studied for the treatment of Thyroid Eye Disease (TED). It is administered through subcutaneous injection (under the skin). This new drug is being tested to see if it can help people with moderate to severe active Thyroid Eye Disease, a condition that causes inflammation and swelling around the eyes. The medication is currently in early stages of clinical research (Phase 1/2) to determine how safe it is, how the body processes it, and how effective it might be in treating the condition.

What is already known about the treatment

AMG 732 – An investigational medication administered via subcutaneous injection that is currently being studied in clinical trials for the treatment of Thyroid Eye Disease (TED). This novel therapeutic agent is undergoing Phase 1/2 trials to evaluate its safety, pharmacokinetics, and effectiveness in patients with moderate-to-severe active TED. While the exact molecular mechanism is still being investigated through clinical research, the drug is being developed specifically to target the underlying causes of inflammatory eye conditions associated with thyroid disorders. The medication represents a new approach in the therapeutic landscape for TED, with ongoing studies to determine its potential role in managing this challenging autoimmune condition.

Investigated diseases

Thyroid Eye Disease - A condition that affects the eyes and surrounding tissues, usually associated with thyroid disorders. The disease causes inflammation and swelling of the muscles and fatty tissues around the eyes, leading to the eyes being pushed forward in their sockets (proptosis). This process can result in eye bulging, double vision, and difficulty closing the eyelids completely. The condition typically develops gradually over time, with periods of active inflammation followed by periods of stability. The changes in eye appearance and vision can vary from mild to severe, affecting one or both eyes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-514110-12-00Protocol code20230302Estimated enrolment40 patientsSponsorAmgen Inc.

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