← Trials/Trial dossier/NCT05056246
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
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
Lead sponsor
Asset
Maridebart cafraglutide / MariTide
Subcutaneous · GLP-1 agonist / GIP antagonist
Listed sites
1
Recruiting sites
—
Enrollment
34
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 18-30•Healthy volunteers
Primary endpoints
•Cmax of Intact AMG 133•Cmax of Total AMG 133•AUC
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
Key Inclusion Criteria:
1. 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)
2. In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations
3. Body mass index between 18 and 30 kg/m^2 at the time of Screening
4. Females of nonchildbearing potential
Key Exclusion Criteria:
1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease
2. History or current signs or symptoms of cardiovascular disease
3. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in
4. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
5. Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening
6. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in
7. Use of tobacco- or nicotine-containing products within 6 months prior to Check-in
8. Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in
9. Female participants with a positive pregnancy test at Screening or Check-in
10. Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit
11. 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
12. Unwilling to abide with study restrictions
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
16 endpointsMaximum 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
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μg/mL | 95% CI |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | 12.3 | — |
| Japanese Participants: AMG 133 Medium Dose | 22.7 | — |
| Japanese Participants: AMG 133 High Dose | 44.9 | — |
| Caucasian Participants: AMG 133 Medium Dose | 22.5 | — |
| Caucasian Participants: AMG 133 High Dose | 55.0 | — |
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
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), μg/mL | 95% CI |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | 13.2 | — |
| Japanese Participants: AMG 133 Medium Dose | 24.8 | — |
| Japanese Participants: AMG 133 High Dose | 48.4 | — |
| Caucasian Participants: AMG 133 Medium Dose | 20.8 | — |
| Caucasian Participants: AMG 133 High Dose | 58.7 | — |
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
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), h*ug/mL | 95% CI |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | 10600 | — |
| Japanese Participants: AMG 133 Medium Dose | 19400 | — |
| Japanese Participants: AMG 133 High Dose | 33500 | — |
| Caucasian Participants: AMG 133 Medium Dose | 17200 | — |
| Caucasian Participants: AMG 133 High Dose | 35700 | — |
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
concentration, descriptive
Posted result
| Group | Value (geometric_mean), h*ug/mL | 95% CI |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | 14800 | — |
| Japanese Participants: AMG 133 Medium Dose | 28300 | — |
| Japanese Participants: AMG 133 High Dose | 47700 | — |
| Caucasian Participants: AMG 133 Medium Dose | 20800 | — |
| Caucasian Participants: AMG 133 High Dose | 49600 | — |
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
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), h*ug/mL | 95% CI |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | 10700 | — |
| Japanese Participants: AMG 133 Medium Dose | 19600 | — |
| Japanese Participants: AMG 133 High Dose | 33900 | — |
| Caucasian Participants: AMG 133 Medium Dose | 17300 | — |
| Caucasian Participants: AMG 133 High Dose | 36000 | — |
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
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), h*ug/mL | 95% CI |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | 15600 | — |
| Japanese Participants: AMG 133 Medium Dose | 30100 | — |
| Japanese Participants: AMG 133 High Dose | 50100 | — |
| Caucasian Participants: AMG 133 Medium Dose | 21800 | — |
| Caucasian Participants: AMG 133 High Dose | 51500 | — |
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
Cmax
concentration, descriptive
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
Cmax
concentration, descriptive
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
concentration, descriptive
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
concentration, descriptive
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
AUC₀–∞
concentration, descriptive
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
AUC₀–∞
concentration, descriptive
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame:Day 1 to Day 120
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | 6 | — |
| Japanese Participants: AMG 133 Medium Dose | 6 | — |
| Japanese Participants: AMG 133 High Dose | 7 | — |
| Caucasian Participants: AMG 133 Medium Dose | 7 | — |
| Caucasian Participants: AMG 133 High Dose | 7 | — |
Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result
Time frame:Days 1, 15, 29, 57 and 120
Immunogenicity (ADA)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Japanese Participants: AMG 133 Low Dose | 3 | — |
| Japanese Participants: AMG 133 Medium Dose | 3 | — |
| Japanese Participants: AMG 133 High Dose | 3 | — |
| Caucasian Participants: AMG 133 Medium Dose | 1 | — |
| Caucasian Participants: AMG 133 High Dose | 0 | — |
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame:Day 1 to Day 120
Treatment-emergent AEs (any)
event count, event
Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result
Time frame:Days 1, 15, 29, 57 and 120
Immunogenicity (ADA)
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.