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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease (NCT06401044) is a Phase 1 / Phase 2 interventional studying Thyroid Eye Disease, sponsored by Amgen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Thyroid Eye Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 88 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Thyroid Eye Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion criteria for Part A/Phase 1 only: - Participant has provided willing to sign a consent form 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

AMG 732

SC injection

OTHER

Placebo

SC injection

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Ilumina Medical Research
Kissimmee, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Vision Medical Research, Inc.
Orland Park, Illinois, United States
Ppd Las Vegas Research Unit
Las Vegas, Nevada, United States
Erie Retina Research
Erie, Pennsylvania, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
Macquarie University
North Ryde, New South Wales, Australia
North Shore Private Hospital
St Leonards, New South Wales, Australia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
Nantes, France
Hopital Pitie-Salpetriere
Paris, France
Universitaetsklinikum Essen
Essen, Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan
Hayashi Eye Hospital
Fukuoka, Fukuoka, Japan
Kozawa Eye Hospital And Diabetes Center
Mito, Ibaraki, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06401044), the sponsor (Amgen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06401044 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06401044?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06401044?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06401044. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06401044. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.