Trial Outcomes & Findings for Multiple Ascending Dose Study of AMG 598 in Adults With Obesity (NCT NCT03757130)
NCT ID: NCT03757130
Last Updated: 2023-09-14
Results Overview
The investigator assessed the severity of each adverse event reported during the study. The assessment was based on the Amgen Standard Grading Scale: Mild: Aware of sign or symptom, but easily tolerated. Moderate: Discomfort enough to cause interference with usual activity. Severe: Incapacitating with inability to work or do usual activity. A Serious adverse event is defined as any untoward medical occurrence that, met at least 1 of the following serious criteria * Death; * Was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Other medically important serious event. The investigator also assessed whether each adverse event was related to study drug administration based on clinical judgement.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
207 days
Results posted on
2023-09-14
Participant Flow
This study was conducted at 2 centers in the United States.
Eligible participants were randomized to one of six treatment cohorts. Within each cohort participants were randomly assigned in a 3:1 ratio to receive either AMG 598 or placebo.
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
7
|
6
|
6
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=8 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
n=6 Participants
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
n=6 Participants
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
41.8 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
41.7 years
STANDARD_DEVIATION 11.3 • n=206 Participants
|
46.1 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 7.8 • n=31 Participants
|
51.5 years
STANDARD_DEVIATION 8.5 • n=30 Participants
|
44.5 years
STANDARD_DEVIATION 10.9 • n=3 Participants
|
49.2 years
STANDARD_DEVIATION 11.7 • n=6 Participants
|
46.5 years
STANDARD_DEVIATION 10.6 • n=114 Participants
|
|
Age, Customized
< 40 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
|
Age, Customized
≥ 40 years
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
36 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
15 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
35 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
41 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
39 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Body Mass Index (BMI)
|
34.22 kg/m²
STANDARD_DEVIATION 2.61 • n=99 Participants
|
33.20 kg/m²
STANDARD_DEVIATION 2.10 • n=107 Participants
|
34.62 kg/m²
STANDARD_DEVIATION 2.92 • n=206 Participants
|
35.46 kg/m²
STANDARD_DEVIATION 2.19 • n=7 Participants
|
34.43 kg/m²
STANDARD_DEVIATION 3.37 • n=31 Participants
|
34.42 kg/m²
STANDARD_DEVIATION 3.24 • n=30 Participants
|
32.77 kg/m²
STANDARD_DEVIATION 3.04 • n=3 Participants
|
36.00 kg/m²
STANDARD_DEVIATION 4.04 • n=6 Participants
|
34.43 kg/m²
STANDARD_DEVIATION 2.92 • n=114 Participants
|
PRIMARY outcome
Timeframe: 207 daysPopulation: All participants who received at least 1 dose of study drug (AMG 598 or placebo) on day 1.
The investigator assessed the severity of each adverse event reported during the study. The assessment was based on the Amgen Standard Grading Scale: Mild: Aware of sign or symptom, but easily tolerated. Moderate: Discomfort enough to cause interference with usual activity. Severe: Incapacitating with inability to work or do usual activity. A Serious adverse event is defined as any untoward medical occurrence that, met at least 1 of the following serious criteria * Death; * Was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Other medically important serious event. The investigator also assessed whether each adverse event was related to study drug administration based on clinical judgement.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=8 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
n=6 Participants
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
n=6 Participants
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
All treatment-emergent adverse events (TEAEs)
|
1 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Mild TEAEs
|
1 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Moderate TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TEAE leading to discontinuation of AMG 598
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
TEAE leading to discontinuation of liraglutide
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Life-threatening TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Fatal TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 207 daysPopulation: All participants who received at least 1 dose of study drug (AMG 598 or placebo) on day 1.
TEAEs due to laboratory, electrocardiogram (ECG) and vital sign findings include any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or electrocardiogram, or vital signs measurements, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator (ie, not related to progression of underlying disease).
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=8 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
n=6 Participants
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
n=6 Participants
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
Electrocardiogram T wave abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
Hepatic enzyme increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
Lipase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
Hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 207Population: The pharmacokinetic (PK) analysis set included all participants for whom at least 1 PK parameter or endpoint could be adequately estimated. Participants with available data at each time point.
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=8 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Day 1
|
5.83 µg/mL
Standard Deviation 1.67
|
7.49 µg/mL
Standard Deviation 1.17
|
21.5 µg/mL
Standard Deviation 5.43
|
18.0 µg/mL
Standard Deviation 5.76
|
51.1 µg/mL
Standard Deviation 9.70
|
36.9 µg/mL
Standard Deviation 13.7
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Day 57
|
9.07 µg/mL
Standard Deviation 1.91
|
12.0 µg/mL
Standard Deviation 2.56
|
45.4 µg/mL
Standard Deviation 12.5
|
34.8 µg/mL
Standard Deviation 12.0
|
93.2 µg/mL
Standard Deviation 18.2
|
72.4 µg/mL
Standard Deviation 23.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 207Population: The PK analysis set; participants with available data at each time point
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=8 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Day 1
|
7.1 days
Interval 7.1 to 14.0
|
7.0 days
Interval 5.0 to 21.0
|
7.1 days
Interval 5.0 to 13.0
|
7.0 days
Interval 4.9 to 14.0
|
6.9 days
Interval 5.0 to 7.3
|
7.0 days
Interval 6.9 to 14.0
|
—
|
—
|
|
Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Day 57
|
7.0 days
Interval 7.0 to 14.0
|
7.0 days
Interval 7.0 to 7.0
|
6.1 days
Interval 5.1 to 7.0
|
6.5 days
Interval 5.0 to 8.0
|
5.3 days
Interval 4.3 to 8.0
|
7.0 days
Interval 7.0 to 11.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 207Population: The PK analysis set; participants with available data at each time point.
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=8 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Day 1
|
0.0833 µg/mL/mg
Standard Deviation 0.0239
|
0.107 µg/mL/mg
Standard Deviation 0.0167
|
0.102 µg/mL/mg
Standard Deviation 0.0258
|
0.0856 µg/mL/mg
Standard Deviation 0.0274
|
0.122 µg/mL/mg
Standard Deviation 0.0231
|
0.0879 µg/mL/mg
Standard Deviation 0.0327
|
—
|
—
|
|
Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Day 57
|
0.130 µg/mL/mg
Standard Deviation 0.0272
|
0.172 µg/mL/mg
Standard Deviation 0.0366
|
0.216 µg/mL/mg
Standard Deviation 0.0593
|
0.168 µg/mL/mg
Standard Deviation 0.0572
|
0.222 µg/mL/mg
Standard Deviation 0.0433
|
0.172 µg/mL/mg
Standard Deviation 0.05949
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85Population: The PK analysis set; participants with available data at each time point.
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=7 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
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
Day 1
|
139 days*µg/mL
Standard Deviation 19.6
|
147 days*µg/mL
Standard Deviation 21.8
|
495 days*µg/mL
Standard Deviation 72.7
|
366 days*µg/mL
Standard Deviation 101
|
1080 days*µg/mL
Standard Deviation 225
|
763 days*µg/mL
Standard Deviation 285
|
—
|
—
|
|
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
Day 57
|
215 days*µg/mL
Standard Deviation 45.3
|
276 days*µg/mL
Standard Deviation 57.6
|
964 days*µg/mL
Standard Deviation 203
|
749 days*µg/mL
Standard Deviation 254
|
1990 days*µg/mL
Standard Deviation 341
|
1610 days*µg/mL
Standard Deviation 511
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85Population: The PK analysis set; participants with available data at each time point.
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=7 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Day 1
|
1.98 days*µg/mL/mg
Standard Deviation 0.279
|
2.10 days*µg/mL/mg
Standard Deviation 0.311
|
2.36 days*µg/mL/mg
Standard Deviation 0.346
|
1.74 days*µg/mL/mg
Standard Deviation 0.480
|
2.57 days*µg/mL/mg
Standard Deviation 0.535
|
1.82 days*µg/mL/mg
Standard Deviation 0.680
|
—
|
—
|
|
Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Day 57
|
3.07 days*µg/mL/mg
Standard Deviation 0.647
|
3.94 days*µg/mL/mg
Standard Deviation 0.823
|
4.59 days*µg/mL/mg
Standard Deviation 0.966
|
3.57 days*µg/mL/mg
Standard Deviation 1.21
|
4.75 days*µg/mL/mg
Standard Deviation 0.812
|
3.84 days*µg/mL/mg
Standard Deviation 1.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207Population: The PK analysis set; participants with available data for AUClast.
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=5 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
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
|
458 days*µg/mL
Standard Deviation 102
|
612 days*µg/mL
Standard Deviation 129
|
2130 days*µg/mL
Standard Deviation 334
|
1570 days*µg/mL
Standard Deviation 462
|
4060 days*µg/mL
Standard Deviation 1610
|
3060 days*µg/mL
Standard Deviation 920
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 207Population: The PK analysis set; participants with available data at both time points.
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. Accumulation ratio for Cmax = Day 57 Cmax / Day 1 Cmax.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=5 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
|
1.62 ratio
Standard Deviation 0.394
|
1.70 ratio
Standard Deviation 0.237
|
2.12 ratio
Standard Deviation 0.251
|
1.92 ratio
Standard Deviation 0.207
|
1.83 ratio
Standard Deviation 0.138
|
2.13 ratio
Standard Deviation 0.418
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85Population: The PK analysis set; participants with available data at both time points.
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. The accumulation ratio for AUC0-28 = Day 57 AUC0-28 / Day 1 AUC0-28.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=5 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=5 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=5 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=5 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=4 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
|
1.74 ratio
Standard Deviation 0.480
|
1.84 ratio
Standard Deviation 0.223
|
2.09 ratio
Standard Deviation 0.254
|
1.86 ratio
Standard Deviation 0.186
|
1.96 ratio
Standard Deviation 0.177
|
2.17 ratio
Standard Deviation 0.291
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207Population: The PK analysis set; participants with available data for T1/2,z
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=6 Participants
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=6 Participants
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=5 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=5 Participants
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57
|
28.2 days
Standard Deviation 3.04
|
31.5 days
Standard Deviation 6.05
|
35.2 days
Standard Deviation 5.86
|
29.1 days
Standard Deviation 3.02
|
35.8 days
Standard Deviation 3.21
|
29.8 days
Standard Deviation 6.72
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo + Liraglutide
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AMG 598 70 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AMG 598 70 mg + Liraglutide
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AMG 598 210 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AMG 598 210 mg + Liraglutide
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AMG 598 420 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AMG 598 420 mg + Liraglutide
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
|
Placebo + Liraglutide
n=6 participants at risk
Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 70 mg
n=6 participants at risk
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 70 mg + Liraglutide
n=8 participants at risk
Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 210 mg
n=6 participants at risk
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 210 mg + Liraglutide
n=6 participants at risk
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
AMG 598 420 mg
n=6 participants at risk
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
|
AMG 598 420 mg + Liraglutide
n=6 participants at risk
Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
12.5%
1/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
12.5%
1/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
12.5%
1/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
66.7%
4/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
25.0%
2/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
50.0%
3/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
25.0%
2/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
General disorders
Early satiety
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
12.5%
1/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Furuncle
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
12.5%
1/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
25.0%
2/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
50.0%
3/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
66.7%
4/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
33.3%
2/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
37.5%
3/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
66.7%
4/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
62.5%
5/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
12.5%
1/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
12.5%
1/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
16.7%
1/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/8 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
0.00%
0/6 • From first dose of AMG 598/placebo through the end of study; 207 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER