CompletedPhase 1Results posted

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

Amgen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Treatment-emergent AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03757130

Org study ID20170139

Timeline

Milestones

Study start2018-11-26actual

Study first posted2018-11-28actual

Primary completion2019-12-16actual

Study completion2019-12-16actual

Last update posted2023-09-14actual

Results first posted2023-09-14actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men and women with ages between 18 and 65 years old, inclusive, at time of signing consent

•Body mass index (BMI) between greater than or equal to 30.0 kg/m^2 and less than or equal to 40.0 kg/m^2 at screening

•Except for obesity, otherwise healthy or medically stable per protocol

•Have a stable body weight defined as less than 5 kg self-reported change during the previous 8 weeks prior to screening

•Other Inclusion criteria may apply

•Stable on liraglutide, depending on cohort

Exclusion criteria

•History or clinical evidence of diabetes

•Inadequate organ function at screening

•Currently receiving treatment in another investigational device or drug study

•Women who are pregnant/lactating/breastfeeding or who plan to become pregnant/breastfeed while on study through 5 months after receiving the last dose of investigational product

•History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

•A family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma; confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for cohorts receiving liraglutide

•History of major depressive disorder

•Other Exclusion criteria may apply

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 endpoints

Primary/registry result

Number of Participants With Treatment-emergent Adverse Events

Time frame:207 days

Treatment-emergent AEs (any)

event count, event

Posted result

Group	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	-

Primary/registry result

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	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	-

Primary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events

Time frame:207 days

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings

Time frame:207 days

Treatment-emergent AEs (any)

event count, event

Secondary/registry result

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	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	-

Secondary/registry result

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	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

Secondary/registry result

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	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	-

Secondary/registry result

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	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	-

Secondary/registry result

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	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	-

Secondary/registry result

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	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	-

Secondary/registry result

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	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	-

Secondary/registry result

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	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	-

Secondary/registry result

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	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	-

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 6, 2026 snapshot.