AzTrials
AzTrials

Thyroid Eye DiseasePhase 1/2NCT06401044

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

A Phase 1/2 study testing AMG 732 in people with Thyroid Eye Disease, run by Amgen at 44 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Thyroid Eye Disease
What is being tested?
AMG 732
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
44 sitesin 12 countries
Study dates
30 May 2024to 24 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.
  • Blood pressure or ECG abnormalities at screening.
  • 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.

Trial locations and contacts

44 sites in 12 countries.

44 sites in 12 countries

United States12 sites

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • Erie Retina Research

    Erie, Pennsylvania, 16505

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • Levenson Eye Associates

    Jacksonville, Florida, 32204

  • Ilumina Medical Research

    Kissimmee, Florida, 34744

  • Ppd Las Vegas Research Unit

    Las Vegas, Nevada, 89113

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Amy Patel Jain MD

    Newport Beach, California, 92660

  • Vision Medical Research, Inc.

    Orland Park, Illinois, 60462

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

Other trials in United States

Germany4 sites

  • Universitaetsklinikum Essen

    Essen, 45147

  • Buergerhospital und Clementine Kinderhospital gGmbH

    Frankfurt am Main, 60318

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04013

Other trials in Germany

Italy4 sites

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Azienda Socio Sanitaria Territoriale dei Sette Laghi

    Varese, 21100

Other trials in Italy

Japan4 sites

  • Hayashi Eye Hospital

    Fukuoka, Fukuoka, 812-0011

  • Kozawa Eye Hospital And Diabetes Center

    Mito, Ibaraki, 310-0845

  • University of Miyazaki Hospital

    Miyazaki, Miyazaki, 889-1692

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi-ken, 480-1195

Other trials in Japan

Poland4 sites

  • Profesorskie Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

    Gdansk, 80-180

  • Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spzoo

    Poznan, 60-354

  • Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa

    Swidnica, 58-100

  • Eb Group Spolka z ograniczona odpowiedzialnoscia

    Warsaw, 00-189

Other trials in Poland

Canada3 sites

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

    Montreal, Quebec, H1T 2M4

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

    Québec, Quebec, G1S 4L8

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 0A6

Other trials in Canada

Spain3 sites

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Australia2 sites

  • Macquarie University

    North Ryde, New South Wales, 2109

  • North Shore Private Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

France2 sites

  • Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec

    Nantes, 44800

  • Hopital Pitie-Salpetriere

    Paris, 75013

Other trials in France

Greece2 sites

  • General Hospital of Athens Laiko

    Athens, 11527

  • Ippokratio General Hospital of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • Singapore National Eye Centre

    Singapore, 169608

Other trials in Singapore

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects With Moderate-to-Severe Active Thyroid Eye Disease

The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.

Read the detailed description

Recruitment has ended for the Phase 1 portion of the study and will reopen when Phase 2 begins recruitment.

Being tested
AMG 732, Placebo
Keywords
AMG 732, Thyroid Eye Disease, TED
Medical subject headings
Graves Ophthalmopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 732Drug

    SC injection

  • PlaceboOther

    SC injection

Study groups in NCT06401044
Study groupRoleWhat they receive
Part A: AMG 732ExperimentalParticipants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Receives: Drug: AMG 732
Part A: PlaceboPlacebo comparatorParticipants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Receives: Other: Placebo
Part B: AMG 732 Low DoseExperimentalParticipants will receive AMG 732 low dose SC.
Receives: Drug: AMG 732
Part B: AMG 732 Medium DoseExperimentalParticipants will receive AMG 732 medium dose SC.
Receives: Drug: AMG 732
Part B: AMG 732 High DoseExperimentalParticipants will receive AMG 732 high dose SC.
Receives: Drug: AMG 732
Part B: PlaceboPlacebo comparatorParticipants will receive placebo SC.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Treatment-emergent Adverse Events

    Measured: Day 1 through Week 36 (End of Study)

  2. Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye

    Measured: Baseline to End of Treatment (EoT) (approximately 6 Months)

Secondary outcomes (15)

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732

    Measured: Up to Week 36

  2. Part A: Time to Cmax (Tmax) of AMG 732

    Measured: Up to Week 36

  3. Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732

    Measured: Up to Week 36

  4. Part A: Half-life (t1/2) of AMG 732

    Measured: Up to Week 36

  5. Part A: Number of Participants With Anti-drug Antibodies (ADAs)

    Measured: Up to Week 36

  6. Part B: Number of Participants With Treatment-emergent Adverse Events

    Measured: Up to Week 48

  7. Part B: Cmax of AMG 732

    Measured: Up to Week 48

  8. Part B: Tmax of AMG 732

    Measured: Up to Week 48

  9. Part B: AUC of AMG 732 Over the Dosing Interval

    Measured: Up to Week 48

  10. Part B: Accumulation of AMG 732 Following Multiple Dosing

    Measured: Up to Week 48

  11. Part B: Half-life (t1/2) of AMG 732

    Measured: Up to Week 48

  12. Part B: Number of Participants With Anti-drug Antibodies (ADAs)

    Measured: Up to Week 48

  13. Part B: Proptosis Response Status in the Study Eye

    Measured: EoT (approximately 6 Months)

  14. Part B: Mean Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Visual Functioning (VF) Subscale Score

    Measured: Baseline to EoT (approximately 6 Months)

  15. Part B: Mean Change from Baseline in the GO-QoL Appearance (A) Subscale Score

    Measured: Baseline to EoT (approximately 6 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start30 May 2024
  3. Primary completion6 Jan 2027 (estimated)
  4. Study completion24 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401044
Sponsor's protocol ID
20230302
Status last verified
Aug 2026
First submitted
2 May 2024
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMG 732 in people with Thyroid Eye Disease, run by Amgen at 44 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Germany, Italy, Japan, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With Treatment-emergent Adverse Events (time frame: Day 1 through Week 36 (End of Study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06401044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in