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Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 598 in Subjects With Obesity
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
4
Recruiting sites
—
Enrollment
50
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
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
Exclusion criteria
Endpoints (22)
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
22 endpointsNumber of Participants With Treatment-emergent Adverse Events
Time frame:207 days
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboAll treatment-emergent adverse events (TEAEs) | 1 | — |
| Mild TEAEs | 1 | — |
| Moderate TEAEs | 0 | — |
| Severe TEAEs | 0 | — |
| Serious TEAEs | 0 | — |
| TEAE leading to discontinuation of AMG 598 | 0 | — |
| TEAE leading to discontinuation of liraglutide | 0 | — |
| Life-threatening TEAEs | 0 | — |
| Fatal TEAEs | 0 | — |
| Placebo + LiraglutideAll treatment-emergent adverse events (TEAEs) | 6 | — |
| Mild TEAEs | 6 | — |
| Moderate TEAEs | 1 | — |
| Severe TEAEs | 0 | — |
| Serious TEAEs | 0 | — |
| TEAE leading to discontinuation of AMG 598 | 0 | — |
| TEAE leading to discontinuation of liraglutide | 1 | — |
| Life-threatening TEAEs | 0 | — |
| Fatal TEAEs | 0 | — |
| AMG 598 70 mgAll treatment-emergent adverse events (TEAEs) | 4 | — |
| Mild TEAEs | 4 | — |
| Moderate TEAEs | 0 | — |
| Severe TEAEs | 0 | — |
| Serious TEAEs | 0 | — |
| TEAE leading to discontinuation of AMG 598 | 0 | — |
| TEAE leading to discontinuation of liraglutide | 0 | — |
| Life-threatening TEAEs | 0 | — |
| Fatal TEAEs | 0 | — |
| AMG 598 70 mg + LiraglutideAll treatment-emergent adverse events (TEAEs) | 7 | — |
| Mild TEAEs | 7 | — |
| Moderate TEAEs | 2 | — |
| Severe TEAEs | 0 | — |
| Serious TEAEs | 0 | — |
| TEAE leading to discontinuation of AMG 598 | 0 | — |
| TEAE leading to discontinuation of liraglutide | 1 | — |
| Life-threatening TEAEs | 0 | — |
| Fatal TEAEs | 0 | — |
| AMG 598 210 mgAll treatment-emergent adverse events (TEAEs) | 5 | — |
| Mild TEAEs | 5 | — |
| Moderate TEAEs | 0 | — |
| Severe TEAEs | 0 | — |
| Serious TEAEs | 0 | — |
| TEAE leading to discontinuation of AMG 598 | 0 | — |
| TEAE leading to discontinuation of liraglutide | 0 | — |
| Life-threatening TEAEs | 0 | — |
| Fatal TEAEs | 0 | — |
| AMG 598 210 mg + LiraglutideAll treatment-emergent adverse events (TEAEs) | 6 | — |
| Mild TEAEs | 6 | — |
| Moderate TEAEs | 0 | — |
| Severe TEAEs | 0 | — |
| Serious TEAEs | 0 | — |
| TEAE leading to discontinuation of AMG 598 | 0 | — |
| TEAE leading to discontinuation of liraglutide | 0 | — |
| Life-threatening TEAEs | 0 | — |
| Fatal TEAEs | 0 | — |
| AMG 598 420 mgAll treatment-emergent adverse events (TEAEs) | 0 | — |
| Mild TEAEs | 0 | — |
| Moderate TEAEs | 0 | — |
| Severe TEAEs | 0 | — |
| Serious TEAEs | 0 | — |
| TEAE leading to discontinuation of AMG 598 | 0 | — |
| TEAE leading to discontinuation of liraglutide | 0 | — |
| Life-threatening TEAEs | 0 | — |
| Fatal TEAEs | 0 | — |
| AMG 598 420 mg + LiraglutideAll treatment-emergent adverse events (TEAEs) | 4 | — |
| Mild TEAEs | 4 | — |
| Moderate TEAEs | 1 | — |
| Severe TEAEs | 0 | — |
| Serious TEAEs | 0 | — |
| TEAE leading to discontinuation of AMG 598 | 1 | — |
| TEAE leading to discontinuation of liraglutide | 2 | — |
| Life-threatening TEAEs | 0 | — |
| Fatal TEAEs | 0 | — |
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
Time frame:207 days
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| PlaceboBlood creatine phosphokinase increased | 0 | — |
| Electrocardiogram T wave abnormal | 0 | — |
| Hepatic enzyme increased | 0 | — |
| Lipase increased | 0 | — |
| Hypertension | 0 | — |
| Placebo + LiraglutideBlood creatine phosphokinase increased | 0 | — |
| Electrocardiogram T wave abnormal | 0 | — |
| Hepatic enzyme increased | 0 | — |
| Lipase increased | 1 | — |
| Hypertension | 0 | — |
| AMG 598 70 mgBlood creatine phosphokinase increased | 0 | — |
| Electrocardiogram T wave abnormal | 0 | — |
| Hepatic enzyme increased | 0 | — |
| Lipase increased | 0 | — |
| Hypertension | 1 | — |
| AMG 598 70 mg + LiraglutideBlood creatine phosphokinase increased | 0 | — |
| Electrocardiogram T wave abnormal | 0 | — |
| Hepatic enzyme increased | 0 | — |
| Lipase increased | 3 | — |
| Hypertension | 0 | — |
| AMG 598 210 mgBlood creatine phosphokinase increased | 1 | — |
| Electrocardiogram T wave abnormal | 0 | — |
| Hepatic enzyme increased | 0 | — |
| Lipase increased | 0 | — |
| Hypertension | 0 | — |
| AMG 598 210 mg + LiraglutideBlood creatine phosphokinase increased | 0 | — |
| Electrocardiogram T wave abnormal | 0 | — |
| Hepatic enzyme increased | 0 | — |
| Lipase increased | 1 | — |
| Hypertension | 0 | — |
| AMG 598 420 mgBlood creatine phosphokinase increased | 0 | — |
| Electrocardiogram T wave abnormal | 0 | — |
| Hepatic enzyme increased | 0 | — |
| Lipase increased | 0 | — |
| Hypertension | 0 | — |
| AMG 598 420 mg + LiraglutideBlood creatine phosphokinase increased | 0 | — |
| Electrocardiogram T wave abnormal | 1 | — |
| Hepatic enzyme increased | 1 | — |
| Lipase increased | 1 | — |
| Hypertension | 0 | — |
Number of Participants With Treatment-emergent Adverse Events
Time frame:207 days
Treatment-emergent AEs (any)
event count, event
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
Time frame:207 days
Treatment-emergent AEs (any)
event count, event
Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Cmax
concentration, descriptive
Posted result
| Group | Value (mean), µg/mL | 95% CI |
|---|---|---|
| AMG 598 70 mgDay 1 | 5.83 | — |
| Day 57 | 9.07 | — |
| AMG 598 70 mg + LiraglutideDay 1 | 7.49 | — |
| Day 57 | 12.0 | — |
| AMG 598 210 mgDay 1 | 21.5 | — |
| Day 57 | 45.4 | — |
| AMG 598 210 mg + LiraglutideDay 1 | 18.0 | — |
| Day 57 | 34.8 | — |
| AMG 598 420 mgDay 1 | 51.1 | — |
| Day 57 | 93.2 | — |
| AMG 598 420 mg + LiraglutideDay 1 | 36.9 | — |
| Day 57 | 72.4 | — |
Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Tmax
descriptive
Posted result
| Group | Value (median), days | 95% CI |
|---|---|---|
| AMG 598 70 mgDay 1 | 7.1 | 7.1 – 14 |
| Day 57 | 7.0 | 7.0 – 14 |
| AMG 598 70 mg + LiraglutideDay 1 | 7.0 | 5.0 – 21 |
| Day 57 | 7.0 | 7.0 – 7.0 |
| AMG 598 210 mgDay 1 | 7.1 | 5.0 – 13 |
| Day 57 | 6.1 | 5.1 – 7.0 |
| AMG 598 210 mg + LiraglutideDay 1 | 7.0 | 4.9 – 14 |
| Day 57 | 6.5 | 5.0 – 8.0 |
| AMG 598 420 mgDay 1 | 6.9 | 5.0 – 7.3 |
| Day 57 | 5.3 | 4.3 – 8.0 |
| AMG 598 420 mg + LiraglutideDay 1 | 7.0 | 6.9 – 14 |
| Day 57 | 7.0 | 7.0 – 11 |
Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Cmax
concentration, descriptive
Posted result
| Group | Value (mean), µg/mL/mg | 95% CI |
|---|---|---|
| AMG 598 70 mgDay 1 | 0.0833 | — |
| Day 57 | 0.130 | — |
| AMG 598 70 mg + LiraglutideDay 1 | 0.107 | — |
| Day 57 | 0.172 | — |
| AMG 598 210 mgDay 1 | 0.102 | — |
| Day 57 | 0.216 | — |
| AMG 598 210 mg + LiraglutideDay 1 | 0.0856 | — |
| Day 57 | 0.168 | — |
| AMG 598 420 mgDay 1 | 0.122 | — |
| Day 57 | 0.222 | — |
| AMG 598 420 mg + LiraglutideDay 1 | 0.0879 | — |
| Day 57 | 0.172 | — |
Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (mean), days*µg/mL | 95% CI |
|---|---|---|
| AMG 598 70 mgDay 1 | 139 | — |
| Day 57 | 215 | — |
| AMG 598 70 mg + LiraglutideDay 1 | 147 | — |
| Day 57 | 276 | — |
| AMG 598 210 mgDay 1 | 495 | — |
| Day 57 | 964 | — |
| AMG 598 210 mg + LiraglutideDay 1 | 366 | — |
| Day 57 | 749 | — |
| AMG 598 420 mgDay 1 | 1080 | — |
| Day 57 | 1990 | — |
| AMG 598 420 mg + LiraglutideDay 1 | 763 | — |
| Day 57 | 1610 | — |
Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (mean), days*µg/mL/mg | 95% CI |
|---|---|---|
| AMG 598 70 mgDay 1 | 1.98 | — |
| Day 57 | 3.07 | — |
| AMG 598 70 mg + LiraglutideDay 1 | 2.10 | — |
| Day 57 | 3.94 | — |
| AMG 598 210 mgDay 1 | 2.36 | — |
| Day 57 | 4.59 | — |
| AMG 598 210 mg + LiraglutideDay 1 | 1.74 | — |
| Day 57 | 3.57 | — |
| AMG 598 420 mgDay 1 | 2.57 | — |
| Day 57 | 4.75 | — |
| AMG 598 420 mg + LiraglutideDay 1 | 1.82 | — |
| Day 57 | 3.84 | — |
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of AMG 598 After Subcutaneous Injection on Day 57
Time frame:Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
concentration, descriptive
Posted result
| Group | Value (mean), days*µg/mL | 95% CI |
|---|---|---|
| AMG 598 70 mg | 458 | — |
| AMG 598 70 mg + Liraglutide | 612 | — |
| AMG 598 210 mg | 2130 | — |
| AMG 598 210 mg + Liraglutide | 1570 | — |
| AMG 598 420 mg | 4060 | — |
| AMG 598 420 mg + Liraglutide | 3060 | — |
Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
ratio, descriptive
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| AMG 598 70 mg | 1.62 | — |
| AMG 598 70 mg + Liraglutide | 1.70 | — |
| AMG 598 210 mg | 2.12 | — |
| AMG 598 210 mg + Liraglutide | 1.92 | — |
| AMG 598 420 mg | 1.83 | — |
| AMG 598 420 mg + Liraglutide | 2.13 | — |
Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
AUC₀–∞
ratio, descriptive
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| AMG 598 70 mg | 1.74 | — |
| AMG 598 70 mg + Liraglutide | 1.84 | — |
| AMG 598 210 mg | 2.09 | — |
| AMG 598 210 mg + Liraglutide | 1.86 | — |
| AMG 598 420 mg | 1.96 | — |
| AMG 598 420 mg + Liraglutide | 2.17 | — |
Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57
Time frame:Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Half-life
descriptive
Posted result
| Group | Value (mean), days | 95% CI |
|---|---|---|
| AMG 598 70 mg | 28.2 | — |
| AMG 598 70 mg + Liraglutide | 31.5 | — |
| AMG 598 210 mg | 35.2 | — |
| AMG 598 210 mg + Liraglutide | 29.1 | — |
| AMG 598 420 mg | 35.8 | — |
| AMG 598 420 mg + Liraglutide | 29.8 | — |
Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Cmax
concentration, descriptive
Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Tmax
descriptive
Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Cmax
concentration, descriptive
Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
AUC₀–∞
concentration, descriptive
Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
AUC₀–∞
concentration, descriptive
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of AMG 598 After Subcutaneous Injection on Day 57
Time frame:Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
AUC₀–∞
concentration, descriptive
Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
ratio, descriptive
Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame:Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
AUC₀–∞
ratio, descriptive
Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57
Time frame:Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Half-life
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.