Not provided
Not provided
Not provided
Not provided
Not provided
Amgen determined the totality of the data does not support continuation of AMG 171 development program for treatment of Obesity. No safety concerns identified.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | AMG 171 or placebo, 2 SAD cohorts |
|
| Part B | Experimental | AMG 171 or placebo, 1 MAD cohort |
|
| Part C | Experimental | AMG 171 or placebo, 3 titration cohorts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 171 | Drug | 2 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A; 1 cohort of 8 subjects 3:1 ratio in Part B; and 24 subjects enrolled into 1 of 3 cohorts with 8 subjects randomized to receive 2 to 3 consecutive doses (titration) 3:1 ratio in Part C. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs. | From first dose of IP to end of study, up to Day 207 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (LLOQ) (50.0 ng/mL) were set to zero before data analysis. | Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120 |
Not provided
Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | 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 datasharing 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.
Participants were enrolled into single ascending dose (SAD) cohorts in Part A (Cohorts 1 and 1b), a multiple dosing cohort in Part B (Cohort 2), and step dosing cohorts in Part C (Cohorts 3 - 5). Three doses were given: Dose A (low dose), Dose B (intermediate dose), and Dose C (high dose).
Participants were enrolled at 3 study centers in the United States, and participated from 13 December 2019 to 10 September 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Cohorts 1 and 1b) | Participants in Part A Cohorts 1 and 1b were randomized to receive a single subcutaneous (SC) dose of placebo on Day 1. |
| FG001 | Cohort 1 (Part A): AMG 171 Dose A | Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1. |
| FG002 | Cohort 1b (Part A): AMG 171 Dose B | Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1. |
| FG003 | Placebo (Cohort 4 Replaced) | Participants enrolled in Part C Cohort 4 received compromised or expired investigational product (IP). These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses. |
| FG004 | Placebo (Cohorts 2-5) | Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo. |
| FG005 | Cohort 2 (Part B): AMG 171 Dose A Q2W | Participants were randomized to receive AMG 171 Dose A every 2 weeks (Q2W) on Days 1, 15, 29, 43, 57, and 71, as SC doses. |
| FG006 | Cohort 3 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses. |
| FG007 | Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C | Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. |
| FG008 | Cohort 5 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses. |
| FG009 | Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Cohort 1 and 1b) | Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1. |
| BG001 | Cohort 1 (Part A): AMG 171 Dose A | Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 Who Experienced Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs. | The safety analysis set included all participants who received at least 1 dose of IP. | Posted | Count of Participants | Participants | From first dose of IP to end of study, up to Day 207 |
|
All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.
All-cause mortality is reported for all participants enrolled/randomized in the study. SAEs and other AEs are reported for all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Cohort 1 and 1b) | Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 24.1 | 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 | Aug 18, 2021 | Apr 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2022 | Apr 26, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | AMG 171 placebo |
|
| Cmax for AMG 171: MAD Cohorts 2 - 5 | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85 |
| Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120 |
| Tmax for AMG 171: MAD Cohorts 2 - 5 | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85 |
| Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120 |
| AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4 | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113 |
| AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5 | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85 |
| Number of Participants With Anti-AMG 171 Antibodies | Serum samples were tested for binding and neutralizing antibodies against human Growth Differentiation Factor 15. Participants with transiently positive for binding or neutralizing antibodies had a negative result at the participant's last time point tested. bAb = binding antibody; nAb = neutralizing antibody; +ve = positive; -ve = negative; BL = baseline. | Cohorts 1 and 1b: Day 1 pre-dose, Days 15, 29, 120; Cohort 2: Days 1, 29, 57 pre-dose, Days 15, 85, 207; Cohort 3: Days 1, 15 pre-dose, Days 29, 57, 85; Cohort 4: Days 1, 15, 29 pre-dose, Days 43, 85, 113; Cohort 5: Days 1, 8 pre-dose, Days 29, 57, 85 |
| Tustin |
| California |
| 92780 |
| United States |
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014 | United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Cohort 1b (Part A): AMG 171 Dose B | Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1. |
| BG003 | Placebo (Cohort 4 Replaced) | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses. |
| BG004 | Placebo (Cohorts 2-5) | Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo. |
| BG005 | Cohort 2 (Part B): AMG 171 Dose A Q2W | Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses. |
| BG006 | Cohort 3 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses. |
| BG007 | Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C | Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. |
| BG008 | Cohort 5 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses. |
| BG009 | Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants in Part A Cohorts 1 and 1b were randomized to receive a single SC dose of placebo on Day 1.
| OG001 | Cohort 1 (Part A): AMG 171 Dose A | Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1. |
| OG002 | Cohort 1b (Part A): AMG 171 Dose B | Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1. |
| OG003 | Placebo (Cohort 4 Replaced) | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses. |
| OG004 | Placebo (Cohorts 2-5) | Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo. |
| OG005 | Cohort 2 (Part B): AMG 171 Dose A Q2W | Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses. |
| OG006 | Cohort 3 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses. |
| OG007 | Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C | Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. |
| OG008 | Cohort 5 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses. |
| OG009 | Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. |
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (LLOQ) (50.0 ng/mL) were set to zero before data analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. | Posted | Mean | Standard Deviation | ng/mL | Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120 |
|
|
|
| Secondary | Cmax for AMG 171: MAD Cohorts 2 - 5 | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. | Posted | Mean | Standard Deviation | ng/mL | Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85 |
|
|
|
| Secondary | Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. | Posted | Median | Full Range | hours | Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120 |
|
|
|
| Secondary | Tmax for AMG 171: MAD Cohorts 2 - 5 | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. | Posted | Median | Full Range | hours | Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. Participants with available data are included. | Posted | Mean | Standard Deviation | hours*ng/mL | Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120 |
|
|
|
| Secondary | AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4 | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. Participants with data available are included. | Posted | Mean | Standard Deviation | hours*ng/mL | Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113 |
|
|
|
| Secondary | AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5 | Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis. | The PK analysis set included all participants who received at least 1 dose of AMG 171 for whom at least 1 PK parameter could be adequately estimated. Participants with data available are included. | Posted | Mean | Standard Deviation | hours*ng/mL | Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85 |
|
|
|
| Secondary | Number of Participants With Anti-AMG 171 Antibodies | Serum samples were tested for binding and neutralizing antibodies against human Growth Differentiation Factor 15. Participants with transiently positive for binding or neutralizing antibodies had a negative result at the participant's last time point tested. bAb = binding antibody; nAb = neutralizing antibody; +ve = positive; -ve = negative; BL = baseline. | The safety analysis set included all participants who received at least 1 dose of IP. Data for participants with an on-study result are included. | Posted | Count of Participants | Participants | Cohorts 1 and 1b: Day 1 pre-dose, Days 15, 29, 120; Cohort 2: Days 1, 29, 57 pre-dose, Days 15, 85, 207; Cohort 3: Days 1, 15 pre-dose, Days 29, 57, 85; Cohort 4: Days 1, 15, 29 pre-dose, Days 43, 85, 113; Cohort 5: Days 1, 8 pre-dose, Days 29, 57, 85 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Cohort 1 (Part A): AMG 171 Dose A | Participants were randomized to receive AMG 171 Dose A as a single SC dose on Day 1. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG002 | Cohort 1b (Part A): AMG 171 Dose B | Participants were randomized to receive AMG 171 Dose B as a single SC dose on Day 1. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Placebo (Cohort 4 Replaced) | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive placebo on Day 1, Day 15, and on Day 29, as SC doses. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG004 | Placebo (Cohorts 2-5) | Participants in Parts B and C (Cohorts 2-5) were randomized to receive multiple SC doses of placebo. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG005 | Cohort 2 (Part B): AMG 171 Dose A Q2W | Participants were randomized to receive AMG 171 Dose A Q2W on Days 1, 15, 29, 43, 57, and 71, as SC doses. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG006 | Cohort 3 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 15, as SC doses. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG007 | Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C | Participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG008 | Cohort 5 (Part C): AMG 171 Dose A/Dose B | Participants were randomized to receive AMG 171 Dose A on Day 1 and Dose B on Day 8, as SC doses. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG009 | Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C | Participants enrolled in Part C Cohort 4 received compromised or expired IP. These participants were randomized to receive AMG 171 Dose A on Day 1, Dose B on Day 15, and Dose C on Day 29, as SC doses. | 0 | 6 | 0 | 6 | 5 | 6 |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 24.1 | 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 |
|
| Day 8 |
|
|
| Day 15 |
|
|
| Day 29 |
|
|
| Day 71 |
|
|
|
| Day 8 |
|
|
| Day 15 |
|
|
| Day 29 |
|
|
| Day 71 |
|
|
| Day 8 |
|
| Day 15 |
|
|
| Day 29 |
|
|
| Day 71 |
|
|
|
| nAb +ve at/before BL |
|
| bAb +ve post-BL with -ve/no result at BL |
|
| Transient bAb +ve post-BL with -ve/no result at BL |
|
| nAb +ve post-BL with -ve/no result at BL |
|
| Transient nAb +ve post-BL with -ve/no result at BL |
|