Healthy ParticipantsPhase 1NCT05056246
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
A Phase 1 study testing AMG 133 in people with Healthy Participants, run by Amgen at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AMG 133
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 8 Apr 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy male or female participants between 18 and 65 years of age (inclusive) at the time of Screening (Japanese participants must be first-generation Japanese)
- In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations
- Body mass index between 18 and 30 kg/m^2 at the time of Screening
- Females of nonchildbearing potential
Who cannot join
- History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease
- History or current signs or symptoms of cardiovascular disease
- History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in
- History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening
- History of alcoholism or drug/chemical abuse within 1 year prior to Check-in
Show all 12Show fewer
- Use of tobacco- or nicotine-containing products within 6 months prior to Check-in
- Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in
- Female participants with a positive pregnancy test at Screening or Check-in
- Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit
- Donation of blood from 3 months prior to Check-in, plasma from 2 weeks prior to Check-in, or platelets from 6 weeks prior to Check-in
- Unwilling to abide with study restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Randomized, Parallel-arm, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Subjects
The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.
- Conditions
- Healthy Participants
- Being tested
- AMG 133
- Keywords
- Maridebart Cafraglutide, Japanese participants, Caucasian participants, AMG 133
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 133Drug
Also called maridebart cafraglutide
Solution for SC injection
| Study group | Role | What they receive |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | Experimental | Healthy Japanese participants will receive the low dose of AMG 133 as a SC injection on Day 1 of the study. Receives: Drug: AMG 133 |
| Japanese Participants: AMG 133 Medium Dose | Experimental | Healthy Japanese participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study. Receives: Drug: AMG 133 |
| Japanese Participants: AMG 133 High Dose | Experimental | Healthy Japanese participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study. Receives: Drug: AMG 133 |
| Caucasian Participants: AMG 133 Medium Dose | Experimental | Healthy Caucasian participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study. Receives: Drug: AMG 133 |
| Caucasian Participants: AMG 133 High Dose | Experimental | Healthy Caucasian participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study. Receives: Drug: AMG 133 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Measured: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Cmax of Total AMG 133
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Measured: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Measured: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
AUClast of Total AMG 133
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Measured: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Measured: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
AUCinf of Total AMG 133
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Measured: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Secondary outcomes (2)
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with AMG 133 that started during or after dosing, or started prior to dosing and increased in severity after dosing.
Clinically significant changes from baseline in clinical laboratory tests, 12-lead electrocardiograms (ECGs) and vital signs were also reported as TEAEs.
Measured: Day 1 to Day 120
Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result
Blood samples were collected at specific times during the study for the measurement of anti-AMG 133 binding antibodies from participants who received AMG 133.
Measured: Days 1, 15, 29, 57 and 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start10 Sep 2021
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056246
- Sponsor's protocol ID
- 20200290
- Status last verified
- Jan 2025
- First submitted
- 15 Sep 2021
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, Parallel-arm, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT05056246
- Acronym / sponsor ID
- 20200290
- Conditions
- Healthy Participants
- Keywords
- Maridebart Cafraglutide, Japanese participants, Caucasian participants, AMG 133
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | Experimental | Drug: AMG 133Healthy Japanese participants will receive the low dose of AMG 133 as a SC injection on Day 1 of the study. |
| Japanese Participants: AMG 133 Medium Dose | Experimental | Drug: AMG 133Healthy Japanese participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study. |
| Japanese Participants: AMG 133 High Dose | Experimental | Drug: AMG 133Healthy Japanese participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study. |
| Caucasian Participants: AMG 133 Medium Dose | Experimental | Drug: AMG 133Healthy Caucasian participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study. |
| Caucasian Participants: AMG 133 High Dose | Experimental | Drug: AMG 133Healthy Caucasian participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female participants between 18 and 65 years of age (inclusive) at the time of Screening (Japanese participants must be first-generation Japanese)
- In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations
- Body mass index between 18 and 30 kg/m^2 at the time of Screening
- Females of nonchildbearing potential
Key exclusion criteria (12 listed)
- History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease
- History or current signs or symptoms of cardiovascular disease
- History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in
- History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 133Also: maridebart cafraglutideSolution for SC injection | Drug | Caucasian Participants: AMG 133 High Dose, Caucasian Participants: AMG 133 Medium Dose, Japanese Participants: AMG 133 High Dose, Japanese Participants: AMG 133 Low Dose, Japanese Participants: AMG 133 Medium Dose |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Cmax of Total AMG 133
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
AUClast of Total AMG 133
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
AUCinf of Total AMG 133
Time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
2 secondary outcomes
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Day 120
Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result
Time frame: Days 1, 15, 29, 57 and 120
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 133 in people with Healthy Participants, run by Amgen at 1 site in United States.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133 (time frame: Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.