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The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
|
| Placebo + Liraglutide | Active Comparator | 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 | Experimental | 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 | Experimental | 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 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 598 | Drug | AMG 598 administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | 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
The investigator also assessed whether each adverse event was related to study drug administration based on clinical judgement. | 207 days |
| Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings | 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). | 207 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William D Summers MD LLC | Birmingham | Alabama | 35235 | United States | ||
| Orange County Research Center |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
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.
This study was conducted at 2 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
| FG001 | 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. |
| FG002 | AMG 598 70 mg | Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
| FG003 | 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. |
| FG004 | AMG 598 210 mg | Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
| FG005 | 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. |
| FG006 | AMG 598 420 mg | Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events | 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
The investigator also assessed whether each adverse event was related to study drug administration based on clinical judgement. | All participants who received at least 1 dose of study drug (AMG 598 or placebo) on day 1. | Posted | Count of Participants | Participants | 207 days |
|
From first dose of AMG 598/placebo through the end of study; 207 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2019 | Nov 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2019 | Nov 4, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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Double-blind study
Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
|
| AMG 598 210 mg + Liraglutide | Experimental | 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 | Experimental | Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
|
| AMG 598 420 mg + Liraglutide | Experimental | 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. |
|
| Placebo | Drug | Placebo matching to AMG 598 administered by subcutaneous injection |
|
| Liraglutide | Drug | Liraglutide administered by subcutaneous injection. The starting dose is 0.6 mg/day, and increased by 0.6 mg/day dose increment every 7 days, up to the full dosage of 3.0 mg/day by week 5. |
|
|
| Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | 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 |
| Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | 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 |
| 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 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85 |
| Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85 |
| 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 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207 |
| Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | 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. | 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 |
| Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | 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. | Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85 |
| Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207 |
| Tustin |
| California |
| 92780 |
| United States |
| QPS Miami Research Associates | South Miami | Florida | 33143 | United States |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | United States |
| Withdrawal by Subject |
|
| BG002 | AMG 598 70 mg | Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
| BG003 | 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. |
| BG004 | AMG 598 210 mg | Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
| BG005 | 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. |
| BG006 | AMG 598 420 mg | Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
| OG000 |
| Placebo |
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
| OG001 | 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. |
| OG002 | AMG 598 70 mg | Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. |
| OG003 | 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. |
| OG004 | AMG 598 210 mg | Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
| OG005 | 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. |
| OG006 | AMG 598 420 mg | Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. |
| OG007 | 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. |
|
|
| Secondary | Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | 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. | Posted | Mean | Standard Deviation | µg/mL | 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 |
|
|
|
| Primary | Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings | 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). | All participants who received at least 1 dose of study drug (AMG 598 or placebo) on day 1. | Posted | Count of Participants | Participants | 207 days |
|
|
|
| Secondary | Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | The PK analysis set; participants with available data at each time point | Posted | Median | Full Range | days | 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 |
|
|
|
| Secondary | Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | The PK analysis set; participants with available data at each time point. | Posted | Mean | Standard Deviation | µg/mL/mg | 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 |
|
|
|
| Secondary | 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 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | The PK analysis set; participants with available data at each time point. | Posted | Mean | Standard Deviation | days*µg/mL | Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85 |
|
|
|
| Secondary | Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | The PK analysis set; participants with available data at each time point. | Posted | Mean | Standard Deviation | days*µg/mL/mg | Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85 |
|
|
|
| Secondary | 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 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | The PK analysis set; participants with available data for AUClast. | Posted | Mean | Standard Deviation | days*µg/mL | Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207 |
|
|
|
| Secondary | Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | 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. | The PK analysis set; participants with available data at both time points. | Posted | Mean | Standard Deviation | ratio | 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 |
|
|
|
| Secondary | Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57 | 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. | The PK analysis set; participants with available data at both time points. | Posted | Mean | Standard Deviation | ratio | Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85 |
|
|
|
| Secondary | Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57 | Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL. | The PK analysis set; participants with available data for T1/2,z | Posted | Mean | Standard Deviation | days | Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | AMG 598 70 mg | Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | 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. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG004 | AMG 598 210 mg | Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG005 | 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. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | AMG 598 420 mg | Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | 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. | 0 | 6 | 0 | 6 | 4 | 6 |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
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.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
|
| Day 57 |
|
|
| Electrocardiogram T wave abnormal |
|
| Hepatic enzyme increased |
|
| Lipase increased |
|
| Hypertension |
|
|
| Day 57 |
|
|
|
| Day 57 |
|
|
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| Day 57 |
|
|
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| Day 57 |
|
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