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

August 7, 2026 updated by: Amgen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • North Ryde, New South Wales, Australia, 2109
        • Macquarie University
      • St Leonards, New South Wales, Australia, 2065
        • North Shore Private Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 0A6
        • Vancouver General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Santé Québec Est-de-l'Île-de-Montréal - Universitaire
      • Québec, Quebec, Canada, G1S 4L8
        • CHU de Québec-Université Laval - CUO-Recherche Clinique, Hopital du Saint-Sacrement
  • France
      • Nantes, France, 44800
        • Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
      • Paris, France, 75013
        • Hôpital Pitié-Salpêtrière
  • Germany
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Frankfurt am Main, Germany, 60318
        • Buergerhospital und Clementine Kinderhospital gGmbH
      • Freiburg im Breisgau, Germany, 79106
        • Universitaetsklinikum Freiburg
      • Leipzig, Germany, 04013
        • Universitaetsklinikum Leipzig AoeR
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens Laiko
      • Thessaloniki, Greece, 54642
        • Ippokratio General Hospital of Thessaloniki
  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Pisa, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Varese, Italy, 21100
        • Azienda Socio Sanitaria Territoriale dei Sette Laghi
  • Japan
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-0011
        • Hayashi Eye Hospital
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0845
        • Kozawa eye hospital and diabetes center
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 889-1692
        • University of Miyazaki Hospital
  • Poland
      • Gdansk, Poland, 80-180
        • Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
      • Poznan, Poland, 60-354
        • Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Spzoo
      • Swidnica, Poland, 58-100
        • Dc-Med Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
      • Warsaw, Poland, 00-189
        • Eb Group Spolka z ograniczona odpowiedzialnoscia
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 169608
        • Singapore National Eye Centre
  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Valencia, Spain, 46026
        • Hospital Universitari I Politècnic La Fe
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Hospital Universitario Virgen Macarena
  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Applied Research Center of Arkansas
    • California
      • Newport Beach, California, United States, 92660
        • Amy Patel Jain MD
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Levenson Eye Associates
      • Kissimmee, Florida, United States, 34744
        • Ilumina Medical Research
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
    • Illinois
      • Orland Park, Illinois, United States, 60462
        • Vision Medical Research, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Ppd Las Vegas Research Unit
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Erie Retina Research
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Medical Center
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: AMG 732
Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Drug: AMG 732
SC injection
Placebo Comparator: Part A: Placebo
Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD).
Other: Placebo
SC injection
Experimental: Part B: AMG 732 Low Dose
Participants will receive AMG 732 low dose SC.
Drug: AMG 732
SC injection
Experimental: Part B: AMG 732 Medium Dose
Participants will receive AMG 732 medium dose SC.
Drug: AMG 732
SC injection
Experimental: Part B: AMG 732 High Dose
Participants will receive AMG 732 high dose SC.
Drug: AMG 732
SC injection
Placebo Comparator: Part B: Placebo
Participants will receive placebo SC.
Other: Placebo
SC injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Part A: Number of Participants With Treatment-emergent Adverse Events
Time Frame: Day 1 through Week 36 (End of Study)
Day 1 through Week 36 (End of Study)
Part B: Change from Baseline in Proptosis Measurement by an Exophthalmometer in the Study Eye
Time Frame: Baseline to End of Treatment (EoT) (approximately 6 Months)
Baseline to End of Treatment (EoT) (approximately 6 Months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Part A: Maximum Observed Plasma Concentration (Cmax) of AMG 732
Time Frame: Up to Week 36
Up to Week 36
Part A: Time to Cmax (Tmax) of AMG 732
Time Frame: Up to Week 36
Up to Week 36
Part A: Area Under the Plasma Concentration-time Curve (AUC) of AMG 732
Time Frame: Up to Week 36
Up to Week 36
Part A: Half-life (t1/2) of AMG 732
Time Frame: Up to Week 36
Up to Week 36
Part A: Number of Participants With Anti-drug Antibodies (ADAs)
Time Frame: Up to Week 36
Up to Week 36
Part B: Number of Participants With Treatment-emergent Adverse Events
Time Frame: Up to Week 48
Up to Week 48
Part B: Cmax of AMG 732
Time Frame: Up to Week 48
Up to Week 48
Part B: Tmax of AMG 732
Time Frame: Up to Week 48
Up to Week 48
Part B: AUC of AMG 732 Over the Dosing Interval
Time Frame: Up to Week 48
Up to Week 48
Part B: Accumulation of AMG 732 Following Multiple Dosing
Time Frame: Up to Week 48
Up to Week 48
Part B: Half-life (t1/2) of AMG 732
Time Frame: Up to Week 48
Up to Week 48
Part B: Number of Participants With Anti-drug Antibodies (ADAs)
Time Frame: Up to Week 48
Up to Week 48
Part B: Mean Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Visual Functioning (VF) Subscale Score
Time Frame: Baseline to EoT (approximately 6 Months)
Baseline to EoT (approximately 6 Months)
Part B: Mean Change from Baseline in the GO-QoL Appearance (A) Subscale Score
Time Frame: Baseline to EoT (approximately 6 Months)
Baseline to EoT (approximately 6 Months)
Part B: Proptosis Response Status in the Study Eye
Time Frame: EoT (approximately 6 Months)
EoT (approximately 6 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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