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Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 133 in Subjects With Obesity
Lead sponsor
Asset
Maridebart cafraglutide / MariTide
Subcutaneous · GLP-1 agonist / GIP antagonist
Listed sites
3
Recruiting sites
—
Enrollment
110
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI 30-40
Primary endpoint
•Treatment-emergent AEs (any)
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
Inclusion criteria
• Postmenopausal as defined as:
Exclusion criteria
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 endpointsNumber of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame:Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), participants | 95% CI |
|---|---|---|
| Part A SAD Cohort 1 AMG 133 | 0 | — |
| Part A SAD Cohort 2 AMG 133 | 2 | — |
| Part A SAD Cohort 3 AMG 133 | 5 | — |
| Part A SAD Cohort 4 AMG 133 | 6 | — |
| Part A SAD Cohort 5 AMG 133 | 5 | — |
| Part A SAD Cohort 6 AMG 133 | 6 | — |
| Part A SAD SC Placebo (Cohorts 1-5, 11) | 3 | — |
| Part A SAD IV Placebo (Cohort 6) | 1 | — |
| Part B MAD Cohort 7 AMG 133 | 6 | — |
| Part B MAD Cohort 8 AMG 133 | 6 | — |
| Part B MAD Cohort 9 AMG 133 | 8 | — |
| Part B MAD Cohort 10 AMG 133 | 8 | — |
| Part B MAD Cohorts 7-9 Placebo | 3 | — |
| Part B MAD Cohort 10 Placebo | 0 | — |
| Part A SAD Cohort 11 AMG 133 | 6 | — |
| Part C MAD Cohort 12 | 5 | — |
| Part C MAD Cohort 13 | 6 | — |
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame:Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days
Treatment-emergent AEs (any)
event count, event
Part A: Maximum Observed Concentration (Cmax) of AMG 133
Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), µg/mL | 95% CI |
|---|---|---|
| Part A SAD Cohort 1 AMG 133Intact AMG 133 | 1.31 | — |
| Total AMG 133 | 1.43 | — |
| Part A SAD Cohort 2 AMG 133Intact AMG 133 | 3.42 | — |
| Total AMG 133 | 3.68 | — |
| Part A SAD Cohort 3 AMG 133Intact AMG 133 | 6.09 | — |
| Total AMG 133 | 6.78 | — |
| Part A SAD Cohort 4 AMG 133Intact AMG 133 | 15.7 | — |
| Total AMG 133 | 17.1 | — |
| Part A SAD Cohort 5 AMG 133Intact AMG 133 | 35.8 | — |
| Total AMG 133 | 37.7 | — |
| Part A SAD Cohort 6 AMG 133Intact AMG 133 | 22.7 | — |
| Total AMG 133 | 22.9 | — |
| Part A SAD Cohort 11 AMG 133Intact AMG 133 | 41.5 | — |
| Total AMG 133 | 43.2 | — |
Part B: Cmax of AMG 133
Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), µg/mL | 95% CI |
|---|---|---|
| Part B MAD Cohort 7 AMG 133Intact AMG 133 after dosing on Day 1 | 8.30 | — |
| Total AMG 133 after dosing on Day 1 | 8.75 | — |
| Intact AMG 133 after dosing on Day 57 | 10.4 | — |
| Total AMG 133 after dosing on Day 57 | 13.1 | — |
| Part B MAD Cohort 8 AMG 133Intact AMG 133 after dosing on Day 1 | 14.5 | — |
| Total AMG 133 after dosing on Day 1 | 16.2 | — |
| Intact AMG 133 after dosing on Day 57 | 21.9 | — |
| Total AMG 133 after dosing on Day 57 | 27.1 | — |
| Part B MAD Cohort 9 AMG 133Intact AMG 133 after dosing on Day 1 | 27.4 | — |
| Total AMG 133 after dosing on Day 1 | 30.1 | — |
| Intact AMG 133 after dosing on Day 57 | 65.1 | — |
| Total AMG 133 after dosing on Day 57 | 80.8 | — |
| Part B MAD Cohort 10 AMG 133Intact AMG 133 after dosing on Day 1 | 17.8 | — |
| Total AMG 133 after dosing on Day 1 | 18.8 | — |
| Intact AMG 133 after dosing on Day 57 | 27.2 | — |
| Total AMG 133 after dosing on Day 57 | 33.2 | — |
Part A: Time of Maximum Observed Concentration (Tmax) of AMG 133
Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150
Tmax
descriptive
Posted result
| Group | Value (median), days | 95% CI |
|---|---|---|
| Part A SAD Cohort 1 AMG 133Intact AMG 133 | 5.0 | 2.9 – 6.9 |
| Total AMG 133 | 5.9 | 4.0 – 6.9 |
| Part A SAD Cohort 2 AMG 133Intact AMG 133 | 4.9 | 3.9 – 6.9 |
| Total AMG 133 | 4.9 | 3.9 – 14 |
| Part A SAD Cohort 3 AMG 133Intact AMG 133 | 6.0 | 5.0 – 13 |
| Total AMG 133 | 7.0 | 6.0 – 13 |
| Part A SAD Cohort 4 AMG 133Intact AMG 133 | 5.8 | 2.8 – 13 |
| Total AMG 133 | 6.9 | 3.8 – 21 |
| Part A SAD Cohort 5 AMG 133Intact AMG 133 | 3.9 | 2.9 – 6.9 |
| Total AMG 133 | 4.4 | 2.9 – 6.9 |
| Part A SAD Cohort 6 AMG 133Intact AMG 133 | 0.025 | 0.0049 – 0.044 |
| Total AMG 133 | 0.043 | 0.0049 – 0.044 |
| Part A SAD Cohort 11 AMG 133Intact AMG 133 | 5.4 | 1.9 – 6.0 |
| Total AMG 133 | 5.9 | 1.9 – 6.0 |
Part B: Tmax of AMG 133
Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207
Tmax
descriptive
Posted result
| Group | Value (median), days | 95% CI |
|---|---|---|
| Part B MAD Cohort 7 AMG 133Intact AMG 133 after dosing on Day 1 | 5.9 | 3.8 – 6.2 |
| Total AMG 133 after dosing on Day 1 | 6.0 | 3.8 – 6.2 |
| Intact AMG 133 after dosing on Day 57 | 4.7 | 4.1 – 15 |
| Total AMG 133 after dosing on Day 57 | 5.6 | 4.1 – 7.2 |
| Part B MAD Cohort 8 AMG 133Intact AMG 133 after dosing on Day 1 | 6.0 | 4.1 – 14 |
| Total AMG 133 after dosing on Day 1 | 6.0 | 4.1 – 14 |
| Intact AMG 133 after dosing on Day 57 | 4.3 | 3.7 – 6.0 |
| Total AMG 133 after dosing on Day 57 | 6.2 | 3.7 – 14 |
| Part B MAD Cohort 9 AMG 133Intact AMG 133 after dosing on Day 1 | 5.9 | 3.9 – 15 |
| Total AMG 133 after dosing on Day 1 | 5.9 | 3.9 – 15 |
| Intact AMG 133 after dosing on Day 57 | 4.1 | 4.0 – 5.1 |
| Total AMG 133 after dosing on Day 57 | 4.1 | 4.0 – 5.1 |
| Part B MAD Cohort 10 AMG 133Intact AMG 133 after dosing on Day 1 | 4.0 | 3.8 – 7.0 |
| Total AMG 133 after dosing on Day 1 | 4.0 | 3.8 – 14 |
| Intact AMG 133 after dosing on Day 57 | 6.0 | 6.0 – 6.0 |
| Total AMG 133 after dosing on Day 57 | 6.0 | 6.0 – 6.0 |
Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of AMG 133
Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), mcg*day/mL | 95% CI |
|---|---|---|
| Part A SAD Cohort 1 AMG 133Intact AMG 133 | 39.0 | — |
| Total AMG 133 | 56.4 | — |
| Part A SAD Cohort 2 AMG 133Intact AMG 133 | 108 | — |
| Total AMG 133 | 151 | — |
| Part A SAD Cohort 3 AMG 133Intact AMG 133 | 230 | — |
| Total AMG 133 | 300 | — |
| Part A SAD Cohort 4 AMG 133Intact AMG 133 | 442 | — |
| Total AMG 133 | 629 | — |
| Part A SAD Cohort 5 AMG 133Intact AMG 133 | 762 | — |
| Total AMG 133 | 1100 | — |
| Part A SAD Cohort 6 AMG 133Intact AMG 133 | 205 | — |
| Total AMG 133 | 264 | — |
| Part A SAD Cohort 11 AMG 133Intact AMG 133 | 1150 | — |
| Total AMG 133 | 1720 | — |
Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133
Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 61, 63, 71, 78 and 85. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 63, 71, 78 and 85
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), mcg*day/mL | 95% CI |
|---|---|---|
| Part B MAD Cohort 7 AMG 133Intact AMG 133 after dosing on Day 1 up to Day 29 | 149 | — |
| Total AMG 133 after dosing on Day 1 up to Day 29 | 181 | — |
| Intact AMG 133 after dosing on Day 57 up to Day 85 | 214 | — |
| Total AMG 133 after dosing on Day 57 up to Day 85 | 297 | — |
| Part B MAD Cohort 8 AMG 133Intact AMG 133 after dosing on Day 1 up to Day 29 | 246 | — |
| Total AMG 133 after dosing on Day 1 up to Day 29 | 300 | — |
| Intact AMG 133 after dosing on Day 57 up to Day 85 | 443 | — |
| Total AMG 133 after dosing on Day 57 up to Day 85 | 599 | — |
| Part B MAD Cohort 9 AMG 133Intact AMG 133 after dosing on Day 1 up to Day 29 | 594 | — |
| Total AMG 133 after dosing on Day 1 up to Day 29 | 697 | — |
| Intact AMG 133 after dosing on Day 57 up to Day 85 | 1220 | — |
| Total AMG 133 after dosing on Day 57 up to Day 85 | 1610 | — |
| Part B MAD Cohort 10 AMG 133Intact AMG 133 after dosing on Day 1 up to Day 29 | 347 | — |
| Total AMG 133 after dosing on Day 1 up to Day 29 | 419 | — |
| Intact AMG 133 after dosing on Day 57 up to Day 85 | 512 | — |
| Total AMG 133 after dosing on Day 57 up to Day 85 | 691 | — |
Percentage of Participants With Anti-AMG 133 Antibody Formation
Time frame:Part A Cohort 1-6 and 11: Up to Day 150. Part B Cohort 7-10 and Part C Cohort 13: Up to Day 207. Part C Cohort 12: Up to Day 193
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Part A SAD Cohort 1 AMG 133Binding antibody positive | 16.7 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part A SAD Cohort 2 AMG 133Binding antibody positive | 50.0 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part A SAD Cohort 3 AMG 133Binding antibody positive | 28.6 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part A SAD Cohort 4 AMG 133Binding antibody positive | 33.3 | — |
| Neutralizing antibody positive | 16.7 | — |
| Part A SAD Cohort 5 AMG 133Binding antibody positive | 16.7 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part A SAD Cohort 6 AMG 133Binding antibody positive | 16.7 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part B MAD Cohort 7 AMG 133Binding antibody positive | 0.0 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part B MAD Cohort 8 AMG 133Binding antibody positive | 33.3 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part B MAD Cohort 9 AMG 133Binding antibody positive | 25.0 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part B MAD Cohort 10 AMG 133Binding antibody positive | 30.0 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part A SAD Cohort 11 AMG 133Binding antibody positive | 33.3 | — |
| Neutralizing antibody positive | 16.7 | — |
| Part C MAD Cohort 12Binding antibody positive | 16.7 | — |
| Neutralizing antibody positive | 0.0 | — |
| Part C MAD Cohort 13Binding antibody positive | 12.5 | — |
| Neutralizing antibody positive | 0.0 | — |
Part A: Maximum Observed Concentration (Cmax) of AMG 133
Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150
Cmax
concentration, descriptive
Part B: Cmax of AMG 133
Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207
Cmax
concentration, descriptive
Part A: Time of Maximum Observed Concentration (Tmax) of AMG 133
Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150
Tmax
descriptive
Part B: Tmax of AMG 133
Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207
Tmax
descriptive
Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of AMG 133
Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150
AUC₀–∞
concentration, descriptive
Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133
Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 61, 63, 71, 78 and 85. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 63, 71, 78 and 85
AUC₀–∞
concentration, descriptive
Percentage of Participants With Anti-AMG 133 Antibody Formation
Time frame:Part A Cohort 1-6 and 11: Up to Day 150. Part B Cohort 7-10 and Part C Cohort 13: Up to Day 207. Part C Cohort 12: Up to Day 193
Immunogenicity (ADA)
threshold achievement, event
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Nature metabolism2024 Feb (month)PMID38316982doi:10.1038/s42255-023-00966-wvia CT.gov background + pubmed nct search
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.