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TerminatedNCT04199351Updated Sep 19, 2024Results posted

Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity

A Phase 1 interventional study of AMG 171 and Placebo in Obesity, sponsored by Amgen. Terminated at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

Why this study was terminated
Amgen determined the totality of the data does not support continuation of AMG 171 development program for treatment of Obesity. No safety concerns identified.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity

02

Conditions studied

  • Obesity

Browse trials for

Keywords

  • Obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Males and females with ages between 18 and 65 years old, inclusive
  • Except for obesity, otherwise healthy
  • Body mass index (BMI) greater than or equal to 30.0 kg/m2 and less than or equal to 40.0 kg/m2 at screening
  • Other Inclusion criteria may apply

Exclusion criteria

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study
  • Women of childbearing potential
  • History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Other Exclusion criteria may apply
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Part A

    AMG 171 or placebo, 2 SAD cohorts

    Drug: AMG 171 · Drug: Placebo

  • Experimental
    Part B

    AMG 171 or placebo, 1 MAD cohort

    Drug: AMG 171 · Drug: Placebo

  • Experimental
    Part C

    AMG 171 or placebo, 3 titration cohorts

    Drug: AMG 171 · Drug: Placebo

Interventions

  • DrugAMG 171

    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.

  • DrugPlacebo

    AMG 171 placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From first dose of IP to end of study, up to Day 207

Secondary outcomes

  1. 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.

    Time frame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120

  2. 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.

    Time frame: 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

  3. 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.

    Time frame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120

  4. 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.

    Time frame: 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

  5. 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.

    Time frame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120

  6. 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.

    Time frame: 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

  7. 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.

    Time frame: Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85

  8. 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.

    Time frame: 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

07

Results

Posted Sep 19, 2024

Participant flow

Participants were enrolled at 3 study centers in the United States, and participated from 13 December 2019 to 10 September 2021.

Participant flow — Overall Study
MilestonePlacebo (Cohorts 1 and 1b)Cohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose BPlacebo (Cohort 4 Replaced)Placebo (Cohorts 2-5)Cohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose BCohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Started4762878666
Completed4650726630
Not completed0112152036
Withdrew: Decision by sponsor0002000006
Withdrew: Lost to follow-up0010010000
Withdrew: Withdrawal by subject0100142030

Outcome measures

PrimaryNumber 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.

Time frame:
From first dose of IP to end of study, up to Day 207
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
ParticipantsPlacebo (Cohort 1 and 1b)Cohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose BPlacebo (Cohort 4 Replaced)Placebo (Cohorts 2-5)Cohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose BCohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
Any TEAEs0560375555
Any SAE0000000000
Any TEAE leading to IP discontinuation0000000000
SecondaryMaximum 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.

Time frame:
Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
Reported as:
Mean · ng/mL
Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b
ng/mLCohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose B
Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b697 ± 4051740 ± 759
SecondaryCmax 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.

Time frame:
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
Reported as:
Mean · ng/mL
Cmax for AMG 171: MAD Cohorts 2 - 5
ng/mLCohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose B
Day 1695 ± 229847 ± 522455 ± 335769 ± 470
Day 8———2550 ± 1820
Day 15—1350 ± 6701760 ± 1080—
Day 29——3960 ± 1600—
Day 711490 ± 702———
SecondaryTime 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.

Time frame:
Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
Reported as:
Median · hours
Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b
hoursCohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose B
Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b120 (47 to 120)120 (72 to 120)
SecondaryTmax 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.

Time frame:
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
Reported as:
Median · hours
Tmax for AMG 171: MAD Cohorts 2 - 5
hoursCohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose B
Day 193 (91 to 310)60 (19 to 310)84 (48 to 190)58 (21 to 160)
Day 8———82 (45 to 220)
Day 15—72 (48 to 310)96 (48 to 120)—
Day 29——110 (72 to 120)—
Day 7172 (61 to 73)———
SecondaryArea 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.

Time frame:
Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
Reported as:
Mean · hours*ng/mL
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b
hours*ng/mLCohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose B
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b285000 ± 72200792000 ± 324000
SecondaryAUC 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.

Time frame:
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
Reported as:
Mean · hours*ng/mL
AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4
hours*ng/mLCohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C
Day 1201000 ± 36400205000 ± 123000133000 ± 74000
Day 15—362000 ± 160000440000 ± 261000
Day 29——1050000 ± 429000
Day 71375000 ± 120000——
SecondaryAUC 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.

Time frame:
Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
Reported as:
Mean · hours*ng/mL
AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5
hours*ng/mLCohort 5 (Part C): AMG 171 Dose A/Dose B
Day 1138000 ± 47200
Day 8351000 ± 272000
SecondaryNumber 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.

Time frame:
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
Reported as:
Count of participants · Participants
Number of Participants With Anti-AMG 171 Antibodies
ParticipantsPlacebo (Cohort 1 and 1b)Cohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose BPlacebo (Cohort 4 Replaced)Placebo (Cohorts 2-5)Cohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose BCohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
bAb +ve at/before BL110——0000—
nAb +ve at/before BL000——0000—
bAb +ve post-BL with -ve/no result at BL012——1001—
Transient bAb +ve post-BL with -ve/no result at BL010——1001—
nAb +ve post-BL with -ve/no result at BL000——0000—
Transient nAb +ve post-BL with -ve/no result at BL000——0000—

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Cohort 1 and 1b)0/4 (0%)0/4 (0%)0/4 (0%)
Cohort 1 (Part A): AMG 171 Dose A0/7 (0%)0/7 (0%)5/7 (71.4%)
Cohort 1b (Part A): AMG 171 Dose B0/6 (0%)0/6 (0%)6/6 (100%)
Placebo (Cohort 4 Replaced)0/2 (0%)0/2 (0%)0/2 (0%)
Placebo (Cohorts 2-5)0/8 (0%)0/8 (0%)3/8 (37.5%)
Cohort 2 (Part B): AMG 171 Dose A Q2W0/7 (0%)0/7 (0%)7/7 (100%)
Cohort 3 (Part C): AMG 171 Dose A/Dose B0/8 (0%)0/8 (0%)5/8 (62.5%)
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C0/6 (0%)0/6 (0%)5/6 (83.3%)
Cohort 5 (Part C): AMG 171 Dose A/Dose B0/6 (0%)0/6 (0%)5/6 (83.3%)
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C0/6 (0%)0/6 (0%)5/6 (83.3%)
Most frequent other events
Showing 10 of 32
Most frequent other events
EventPlacebo (Cohort 1 and 1b)Cohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose BPlacebo (Cohort 4 Replaced)Placebo (Cohorts 2-5)Cohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose BCohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C
NauseaGastrointestinal disorders0/44/76/60/21/85/74/85/64/64/6
VomitingGastrointestinal disorders0/41/74/60/20/84/71/82/64/62/6
ConstipationGastrointestinal disorders0/40/70/60/21/80/70/80/63/60/6
HeadacheNervous system disorders0/42/70/60/20/81/73/81/62/61/6
Abdominal pain upperGastrointestinal disorders0/40/70/60/20/80/70/80/62/60/6
Decreased appetiteMetabolism and nutrition disorders0/40/70/60/20/80/72/80/61/60/6
PalpitationsCardiac disorders0/40/70/60/20/80/70/81/60/60/6
Abdominal discomfortGastrointestinal disorders0/40/70/60/20/80/70/80/60/61/6
Abdominal painGastrointestinal disorders0/40/71/60/20/80/71/80/60/60/6
Bowel movement irregularityGastrointestinal disorders0/40/70/60/20/80/70/80/61/60/6

Baseline characteristics

Age, Customized
Age, Customized(Participants)Placebo (Cohort 1 and 1b)Cohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose BPlacebo (Cohort 4 Replaced)Placebo (Cohorts 2-5)Cohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose BCohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose CTotal
< 18 years00000000000
18 - 64 years476287866660
≥ 65 years00000000000
Sex: Female, Male
Sex: Female, Male(Participants)Placebo (Cohort 1 and 1b)Cohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose BPlacebo (Cohort 4 Replaced)Placebo (Cohorts 2-5)Cohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose BCohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose CTotal
Female201122213216
Male275165653444
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo (Cohort 1 and 1b)Cohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose BPlacebo (Cohort 4 Replaced)Placebo (Cohorts 2-5)Cohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose BCohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose CTotal
Hispanic or Latino343243261634
Not Hispanic or Latino133044605026
Unknown or Not Reported00000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo (Cohort 1 and 1b)Cohort 1 (Part A): AMG 171 Dose ACohort 1b (Part A): AMG 171 Dose BPlacebo (Cohort 4 Replaced)Placebo (Cohorts 2-5)Cohort 2 (Part B): AMG 171 Dose A Q2WCohort 3 (Part C): AMG 171 Dose A/Dose BCohort 4 (Part C): AMG 171 Dose A/Dose B/Dose CCohort 5 (Part C): AMG 171 Dose A/Dose BCohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose CTotal
American Indian or Alaska Native00000000000
Asian00000000000
Native Hawaiian or Other Pacific Islander00001000001
Black or African American012044304321
White464233562338
More than one race00000000000
Unknown or Not Reported00000000000
08

Study locations

3 sites
  • Anaheim Clinical Trials
    Anaheim, California 92801, United States
  • Orange County Research Center
    Tustin, California 92780, United States
  • Clinical Pharmacology of Miami, LLC
    Miami, Florida 33014, United States
09

References and documents

Study documents

  • Study protocol · Aug 18, 2021
  • Statistical analysis plan · Feb 1, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04199351
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Dec 13, 2019
Start date
Dec 13, 2019
Primary completion
Sep 10, 2021
Completion
Sep 10, 2021
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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