← Trials/Trial dossier/NCT04478708

CompletedPhase 1Results posted

Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 133 in Subjects With Obesity

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

3

Recruiting sites

Enrollment

110

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 30-40

Primary endpoint

Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04478708
Org study ID20180048

Timeline

Milestones

Study first posted2020-07-21actual
Study start2020-08-07actual
Primary completion2022-11-18actual
Study completion2022-11-18actual
Last update posted2025-12-10actual
Results first posted2025-12-10actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Participant has provided informed consent before initiation of any study-specific activities/procedures.
Age ≥ 18 years to ≤ 65 years, at the time of signing the informed consent.
Except for obesity, otherwise healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and ECGs on day -2 (cohorts 1-6, cohort 11-13) or day -1 (cohorts 7-10) and screening.
Body mass index between ≥ 30.0 kg/m^2 and ≤ 40.0 kg/m^2.
Have a stable body weight (< 5 kg self-reported change during the previous 8 weeks) before screening.
Willing to maintain current general diet and physical activity regimen, except for the physical activity in the 72 hours before each blood sample collection for the clinical laboratory analysis, which should not be strenuous.
Females must be of nonreproductive potential

• Postmenopausal as defined as:

Age of ≥ 55 years with no menses for at least 12 months; OR
Age < 55 years with no menses for at least 12 months AND with a follicle-stimulating hormone level > 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR
History of hysterectomy; OR
History of bilateral oophorectomy.
For patients in cohorts 7-10 only, participants must have a smartphone device with the capability of downloading apps or other digital tools required for this cohort.

Exclusion criteria

History or clinical evidence of diabetes mellitus, including hemoglobin A1c (HbA1c) > 6.5% and/or a fasting glucose ≥ 125 mg/dl (6.9 mmol/L) at screening.
Triglycerides ≥ 5.65 mmol/L (ie, 500 mg/dL) at screening.
Screening calcitonin ≥ 50 ng/L.
Hepatic liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin levels > 1.5 times the upper limit of normal (ULN) at screening. If ALT is > 1.5 x the ULN at screening AND the AST, alkaline phosphatase, and total bilirubin levels are within normal limits, then participant may be eligible for enrollment after a discussion with the medical monitor.
History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (PTT), international normalized ratio (INR), or platelet count outside of the laboratory's normal reference range at screening. If a single value (PT, PTT, INR, or platelet count) is outside the normal reference range at screening and the participant does not have evidence of any other bleeding or coagulation disorder, then the participant may be eligible for enrollment after a discussion with the medical monitor.
History of gastrointestinal abnormality that could affect gastrointestinal motility (including small bowel or colonic resection, inflammatory bowel disease, irritable bowel disease, and colon or gastrointestinal tract cancer).
Participants with a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 or a personal history of nonfamilial medullary thyroid carcinoma.
Participants with a history of confirmed chronic pancreatitis or idiopathic acute pancreatitis.
Participants with a history of gall bladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy.
Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid stimulating hormone > 6 mIU/L or <0.4 mIU/L.
A corrected QT interval (QTc) at screening of > 450 msec in males or > 470 msec in females or history of long QT syndrome.
Participants with a history of renal impairment or renal disease and/or estimated glomerular filtration rate ≤ 60 mL/min/1.73 m^2.
Obesity induced by other endocrinologic disorders (eg, Cushing's Syndrome).
Previous surgical treatment for obesity (excluding liposuction if performed >1 year before study entry) and/or participants with recent (within 6 months) or planned endoscopic treatment for obesity.
History of major depressive disorder.
History of other severe psychiatric disorders, eg schizophrenia, bipolar disorder.
Any lifetime history of a suicidal attempt or of any suicidal behavior.
Surgery scheduled for the study duration period, except for minor surgical procedures, at the discretion of the investigator.
Positive results for human immunodeficiency virus antibodies, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus RNA. For hepatitis C, hepatitis C antibody testing is done at screening, followed by hepatitis C virus RNA by polymerase chain reaction if hepatitis C antibody is positive.
Systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg at screening, or on day -2. For each visit, if the initial blood pressure is elevated, the reading may be repeated once at least 15 minutes later and the lower of the 2 readings may be used.
History of malignancy of any type, other than in situ cervical cancer or surgically excised nonmelanomatous skin cancers occurring more than 5 years before randomization.
Use of the following agents are excluded unless there is a prior consultation between the investigator and Amgen medical monitor:
Prescription and nonprescription drugs within 14 days or 5 half-lives, whichever is longer, before the first dose of investigational product, with exception of hormone replacement therapy (eg, estrogen, thyroid).
All herbal medicines, vitamins, and supplements within 30 days before receiving the first dose of investigational product.
Exceptions must be reviewed and approved by the investigator and Amgen medical monitor. Written documentation of this review and Amgen acknowledgment is required for participant participation.
Current or history of treatment with medications that may cause significant weight gain or loss, within 3 months before screening, including systemic corticosteroids (except for a short course of treatment, ie, 7 to 10 days), tricyclic antidepressants, atypical antipsychotic and mood stabilizers (eg, imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
Current participation (or within the last 3 months) in an organized weight reduction program or currently using or used within 3 months before screening: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, bupropion, lorcaserin, metformin, or any GLP-1R agonists (either by prescription or as part of a clinical study).
Prior exposure to maridebart cafraglutide or AMG 598 or currently receiving treatment in another investigational device or drug study, or less than 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
Female participants with a positive pregnancy test assessed at screening and/or day -2 by a serum pregnancy test and/or urine pregnancy test) or female participants who are breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 months after the last dose of maridebart cafraglutide.
Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use an acceptable method of contraception during treatment and for an additional 5 months after the last dose of maridebart cafraglutide.
Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of maridebart cafraglutide.
Participant has known sensitivity to maridebart cafraglutide or components thereof or a history of drug or other allergy that is in the opinion of the investigator or medical monitor (if appropriate), contraindicates their participation.
Participant has a known sensitivity to GLP-1R agonists.
Participant has known sensitivity to mammalian derived products.
Participant has an allergy or known sensitivity to acetaminophen.
Participant is unwilling or unable to limit alcohol consumption throughout the course of the study. Alcohol is prohibited 48 hours before day -2 and is limited to no more than to 2 drinks per day for males and 1 drink per day for females for the duration of the study (1 drink being equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits).
Participant uses nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, e-cigarettes, pipes, or nicotine patches) within 6 months before screening. Participant is unwilling or unable to abstain from nicotine or tobacco, cigars, cigarettes, pipes, or nicotine patches throughout the course of the study.
Participant is tested positive for alcohol and/or drugs of abuse at screening.
History of substance abuse (ie, alcohol, licit or illicit drugs) within 12 months before screening.
Participant is unwilling to refrain from strenuous exercise (eg, heavy lifting, weight training, and aerobics) for 72 hours before each blood collection for clinical laboratory tests.
Participant has donated or lost ≥ 500 mL of blood or plasma within 60 days of day -2.
Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
For participants in cohorts 7-10 and cohorts 12-13 only, the Patient Health Questionnaire-9 (PHQ-9) score of ≥ 10 up to day 1.
For participants in cohorts 7-10 and 12-13 only, any suicidal ideation as identified by endorsement of (answered yes to) any of the items numbered 1-5 on the Columbia Suicide Severity Rating Scale (C-SSRS) up to day 1.
For participants in cohorts 7-10 and 12-13 only, participant has systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 95 mm Hg on day 1. For each visit, if the initial blood pressure is elevated, the reading may be repeated once at least 15 minutes later and the lower of the 2 readings may be used.
For participants in cohorts 7-10 and 12-13 only, a QTc of > 450 msec in males or > 470 msec in females up to day 1.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

16 endpoints
Primary/registry result

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), participants95% CI
Part A SAD Cohort 1 AMG 1330
Part A SAD Cohort 2 AMG 1332
Part A SAD Cohort 3 AMG 1335
Part A SAD Cohort 4 AMG 1336
Part A SAD Cohort 5 AMG 1335
Part A SAD Cohort 6 AMG 1336
Part A SAD SC Placebo (Cohorts 1-5, 11)3
Part A SAD IV Placebo (Cohort 6)1
Part B MAD Cohort 7 AMG 1336
Part B MAD Cohort 8 AMG 1336
Part B MAD Cohort 9 AMG 1338
Part B MAD Cohort 10 AMG 1338
Part B MAD Cohorts 7-9 Placebo3
Part B MAD Cohort 10 Placebo0
Part A SAD Cohort 11 AMG 1336
Part C MAD Cohort 125
Part C MAD Cohort 136
Primary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days

Treatment-emergent AEs (any)

event count, event

Secondary/registry result

Part A: Maximum Observed Concentration (Cmax) of AMG 133

Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), µg/mL95% CI
Part A SAD Cohort 1 AMG 133Intact AMG 1331.31
Total AMG 1331.43
Part A SAD Cohort 2 AMG 133Intact AMG 1333.42
Total AMG 1333.68
Part A SAD Cohort 3 AMG 133Intact AMG 1336.09
Total AMG 1336.78
Part A SAD Cohort 4 AMG 133Intact AMG 13315.7
Total AMG 13317.1
Part A SAD Cohort 5 AMG 133Intact AMG 13335.8
Total AMG 13337.7
Part A SAD Cohort 6 AMG 133Intact AMG 13322.7
Total AMG 13322.9
Part A SAD Cohort 11 AMG 133Intact AMG 13341.5
Total AMG 13343.2
Secondary/registry result

Part B: Cmax of AMG 133

Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), µg/mL95% CI
Part B MAD Cohort 7 AMG 133Intact AMG 133 after dosing on Day 18.30
Total AMG 133 after dosing on Day 18.75
Intact AMG 133 after dosing on Day 5710.4
Total AMG 133 after dosing on Day 5713.1
Part B MAD Cohort 8 AMG 133Intact AMG 133 after dosing on Day 114.5
Total AMG 133 after dosing on Day 116.2
Intact AMG 133 after dosing on Day 5721.9
Total AMG 133 after dosing on Day 5727.1
Part B MAD Cohort 9 AMG 133Intact AMG 133 after dosing on Day 127.4
Total AMG 133 after dosing on Day 130.1
Intact AMG 133 after dosing on Day 5765.1
Total AMG 133 after dosing on Day 5780.8
Part B MAD Cohort 10 AMG 133Intact AMG 133 after dosing on Day 117.8
Total AMG 133 after dosing on Day 118.8
Intact AMG 133 after dosing on Day 5727.2
Total AMG 133 after dosing on Day 5733.2
Secondary/registry result

Part A: Time of Maximum Observed Concentration (Tmax) of AMG 133

Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150

Tmax

descriptive

Posted result

GroupValue (median), days95% CI
Part A SAD Cohort 1 AMG 133Intact AMG 1335.02.9 – 6.9
Total AMG 1335.94.0 – 6.9
Part A SAD Cohort 2 AMG 133Intact AMG 1334.93.9 – 6.9
Total AMG 1334.93.9 – 14
Part A SAD Cohort 3 AMG 133Intact AMG 1336.05.0 – 13
Total AMG 1337.06.0 – 13
Part A SAD Cohort 4 AMG 133Intact AMG 1335.82.8 – 13
Total AMG 1336.93.8 – 21
Part A SAD Cohort 5 AMG 133Intact AMG 1333.92.9 – 6.9
Total AMG 1334.42.9 – 6.9
Part A SAD Cohort 6 AMG 133Intact AMG 1330.0250.0049 – 0.044
Total AMG 1330.0430.0049 – 0.044
Part A SAD Cohort 11 AMG 133Intact AMG 1335.41.9 – 6.0
Total AMG 1335.91.9 – 6.0
Secondary/registry result

Part B: Tmax of AMG 133

Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207

Tmax

descriptive

Posted result

GroupValue (median), days95% CI
Part B MAD Cohort 7 AMG 133Intact AMG 133 after dosing on Day 15.93.8 – 6.2
Total AMG 133 after dosing on Day 16.03.8 – 6.2
Intact AMG 133 after dosing on Day 574.74.1 – 15
Total AMG 133 after dosing on Day 575.64.1 – 7.2
Part B MAD Cohort 8 AMG 133Intact AMG 133 after dosing on Day 16.04.1 – 14
Total AMG 133 after dosing on Day 16.04.1 – 14
Intact AMG 133 after dosing on Day 574.33.7 – 6.0
Total AMG 133 after dosing on Day 576.23.7 – 14
Part B MAD Cohort 9 AMG 133Intact AMG 133 after dosing on Day 15.93.9 – 15
Total AMG 133 after dosing on Day 15.93.9 – 15
Intact AMG 133 after dosing on Day 574.14.0 – 5.1
Total AMG 133 after dosing on Day 574.14.0 – 5.1
Part B MAD Cohort 10 AMG 133Intact AMG 133 after dosing on Day 14.03.8 – 7.0
Total AMG 133 after dosing on Day 14.03.8 – 14
Intact AMG 133 after dosing on Day 576.06.0 – 6.0
Total AMG 133 after dosing on Day 576.06.0 – 6.0
Secondary/registry result

Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of AMG 133

Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), mcg*day/mL95% CI
Part A SAD Cohort 1 AMG 133Intact AMG 13339.0
Total AMG 13356.4
Part A SAD Cohort 2 AMG 133Intact AMG 133108
Total AMG 133151
Part A SAD Cohort 3 AMG 133Intact AMG 133230
Total AMG 133300
Part A SAD Cohort 4 AMG 133Intact AMG 133442
Total AMG 133629
Part A SAD Cohort 5 AMG 133Intact AMG 133762
Total AMG 1331100
Part A SAD Cohort 6 AMG 133Intact AMG 133205
Total AMG 133264
Part A SAD Cohort 11 AMG 133Intact AMG 1331150
Total AMG 1331720
Secondary/registry result

Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133

Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 61, 63, 71, 78 and 85. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 63, 71, 78 and 85

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), mcg*day/mL95% CI
Part B MAD Cohort 7 AMG 133Intact AMG 133 after dosing on Day 1 up to Day 29149
Total AMG 133 after dosing on Day 1 up to Day 29181
Intact AMG 133 after dosing on Day 57 up to Day 85214
Total AMG 133 after dosing on Day 57 up to Day 85297
Part B MAD Cohort 8 AMG 133Intact AMG 133 after dosing on Day 1 up to Day 29246
Total AMG 133 after dosing on Day 1 up to Day 29300
Intact AMG 133 after dosing on Day 57 up to Day 85443
Total AMG 133 after dosing on Day 57 up to Day 85599
Part B MAD Cohort 9 AMG 133Intact AMG 133 after dosing on Day 1 up to Day 29594
Total AMG 133 after dosing on Day 1 up to Day 29697
Intact AMG 133 after dosing on Day 57 up to Day 851220
Total AMG 133 after dosing on Day 57 up to Day 851610
Part B MAD Cohort 10 AMG 133Intact AMG 133 after dosing on Day 1 up to Day 29347
Total AMG 133 after dosing on Day 1 up to Day 29419
Intact AMG 133 after dosing on Day 57 up to Day 85512
Total AMG 133 after dosing on Day 57 up to Day 85691
Secondary/registry result

Percentage of Participants With Anti-AMG 133 Antibody Formation

Time frame:Part A Cohort 1-6 and 11: Up to Day 150. Part B Cohort 7-10 and Part C Cohort 13: Up to Day 207. Part C Cohort 12: Up to Day 193

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupValue (number), percentage of participants95% CI
Part A SAD Cohort 1 AMG 133Binding antibody positive16.7
Neutralizing antibody positive0.0
Part A SAD Cohort 2 AMG 133Binding antibody positive50.0
Neutralizing antibody positive0.0
Part A SAD Cohort 3 AMG 133Binding antibody positive28.6
Neutralizing antibody positive0.0
Part A SAD Cohort 4 AMG 133Binding antibody positive33.3
Neutralizing antibody positive16.7
Part A SAD Cohort 5 AMG 133Binding antibody positive16.7
Neutralizing antibody positive0.0
Part A SAD Cohort 6 AMG 133Binding antibody positive16.7
Neutralizing antibody positive0.0
Part B MAD Cohort 7 AMG 133Binding antibody positive0.0
Neutralizing antibody positive0.0
Part B MAD Cohort 8 AMG 133Binding antibody positive33.3
Neutralizing antibody positive0.0
Part B MAD Cohort 9 AMG 133Binding antibody positive25.0
Neutralizing antibody positive0.0
Part B MAD Cohort 10 AMG 133Binding antibody positive30.0
Neutralizing antibody positive0.0
Part A SAD Cohort 11 AMG 133Binding antibody positive33.3
Neutralizing antibody positive16.7
Part C MAD Cohort 12Binding antibody positive16.7
Neutralizing antibody positive0.0
Part C MAD Cohort 13Binding antibody positive12.5
Neutralizing antibody positive0.0
Secondary/protocol endpoint

Part A: Maximum Observed Concentration (Cmax) of AMG 133

Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part B: Cmax of AMG 133

Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part A: Time of Maximum Observed Concentration (Tmax) of AMG 133

Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150

Tmax

descriptive

Secondary/protocol endpoint

Part B: Tmax of AMG 133

Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 61, 63, 71, 78, 85, 127, 169 and 207. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 36, 43, 50, 57 (predose), 63, 71, 78, 85, 169 and 207

Tmax

descriptive

Secondary/protocol endpoint

Part A: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of AMG 133

Time frame:Cohort 1-5, 11: Day 1 predose and 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 7, 8, 15, 22, 29, 43, 57, 71, 92, 120 and 150. Cohort 6: Day 1 predose and 10 mins, 1, 2, 4 and 8 hours postdose, Day 2, 3, 4, 5, 6, 15, 22, 29, 43, 57, 71, 92, 120 and 150

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part B: AUC From Day 0 to 28 (AUC0-28) of AMG 133

Time frame:Cohorts 7-9: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 61, 63, 71, 78 and 85. Cohort 10: Day 1 (predose), Day 5, 7, 15, 22, 29 (predose), 57 (predose), 63, 71, 78 and 85

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Percentage of Participants With Anti-AMG 133 Antibody Formation

Time frame:Part A Cohort 1-6 and 11: Up to Day 150. Part B Cohort 7-10 and Part C Cohort 13: Up to Day 207. Part C Cohort 12: Up to Day 193

Immunogenicity (ADA)

threshold achievement, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.