Recent Updates
Recently added Catalysts

AMG 133

Phase 1

Healthy Participants | Small molecule | Other |Amgen Inc.|Last Updated: Jul 21, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

AMG 133 · 7 trials · 6 indications

Phase 1 7
NCT07429032The Effect of AMG 133 on Gastric EmptyingOverweight or Obesity
COMPLETED57 Analytics
NCT07428525A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic FunctionHepatic Impairment
COMPLETED36 Analytics
NCT07429045A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the BodyOverweight and Obesity
COMPLETED44 Analytics
NCT07310563A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or ObesityOverweight
COMPLETED59 Analytics
NCT07717814A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or ObesityOverweight and Obesity
COMPLETED154 Analytics
NCT06976372A Study to Evaluate AMG 133 Administered Subcutaneously in Participants With Overweight or ObesityOverweight
COMPLETED120 Analytics
NCT05056246Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian ParticipantsHealthy Participants
COMPLETED34 Analytics
PHASE1COMPLETED
The Effect of AMG 133 on Gastric Emptying
Overweight or Obesity
NCT0742903257
Unlock trial analytics
PHASE1COMPLETED
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
Hepatic Impairment
NCT0742852536
Unlock trial analytics
PHASE1COMPLETED
A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the Body
Overweight and Obesity
NCT0742904544
Unlock trial analytics
PHASE1COMPLETED
A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity
Overweight
NCT0731056359
Unlock trial analytics
PHASE1COMPLETED
A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity
Overweight and Obesity
NCT07717814154
Unlock trial analytics
PHASE1COMPLETED
A Study to Evaluate AMG 133 Administered Subcutaneously in Participants With Overweight or Obesity
Overweight
NCT06976372120
Unlock trial analytics
PHASE1COMPLETED
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
Healthy Participants
NCT0505624634
Unlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) for Acetaminophen
Days 1, 3, 8, 17, 31, 59, 64, and 86
Time to Cmax (Tmax) for Acetaminophen
Days 1, 3, 8, 17, 31, 59, 64, and 86
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) for Acetaminophen
Days 1, 3, 8, 17, 31, 59, 64, and 86
AUC from Time Zero to Infinity (AUCinf) for Acetaminophen
Days 1, 3, 8, 17, 31, 59, 64, and 86
AUC from Time Zero to 5 Hours (AUC5hr) for Acetaminophen
Days 1, 3, 8, 17, 31, 59, 64, and 86
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Up to Day 120
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133
Up to Day 120
AUC from Time Zero to Infinity (AUCinf) of AMG 133
Up to Day 120
Maximum Observed Concentration (Cmax) of AMG 133
Up to Day 120
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
Up to Day 120
AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133
Up to Day 120
Area Under the Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
Up to Day 120
Maximum Concentration (Cmax) of AMG 133
Up to Day 99
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133
Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 133
Day 29
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of AMG 133
Day 1 and Day 15
Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133
Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.

Cmax of Total AMG 133
Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133
Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.

AUClast of Total AMG 133
Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.

Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133
Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.

AUCinf of Total AMG 133
Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose

Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.

Secondary Endpoints

Cmax for AMG 133
Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128
AUClast for AMG 133
Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128
AUCinf for AMG 133
Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AMG 133EXPERIMENTALParticipants will receive AMG 133 subcutaneously (SC) and acetaminophen orally.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo SC and acetaminophen orally.
Group 1, AMG 133: Normal Hepatic Function (No Impairment)EXPERIMENTALParticipants with normal hepatic function will receive a single dose of AMG 133 SC on Day 1.
Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment)EXPERIMENTALParticipants with mild hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment)EXPERIMENTALParticipants with moderate hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment)EXPERIMENTALParticipants with severe hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
Group 1: Normal renal functionEXPERIMENTALParticipants with an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min will receive a single dose of AMG 133 as a SC injection.
Group 2: Mild renal impairmentEXPERIMENTALParticipants with an eGFR of 60 to \< 90 mL/min will receive a single dose of AMG 133 as a SC injection.
Group 3: Moderate renal impairmentEXPERIMENTALParticipants with an eGFR of 30 to \< 60 mL/min will receive a single dose of AMG 133 as a SC injection.
Group 4: Severe renal impairment and kidney failure not receiving hemodialysisEXPERIMENTALParticipants with an eGFR of \< 30 mL/min will receive a single dose of AMG 133 as a SC injection.
Group 5: Kidney failure receiving hemodialysisEXPERIMENTALParticipants with an eGFR of \< 15 mL/min will receive a single dose of AMG 133 as a SC injection.
Low Dose AMG 133 without OndansetronEXPERIMENTALParticipants will receive a single subcutaneous (SC) low dose of 70 mg AMG 133.
High Dose AMG 133 without OndansetronEXPERIMENTALParticipants will receive a single SC high dose of 350 mg AMG 133.
Low Dose AMG 133 with OndansetronEXPERIMENTALParticipants will receive a single SC low dose of 70 mg AMG 133 and ondansetron 8 mg orally disintegrating tablet (ODT) every 8 hours for 72 hours.
High Dose AMG 133 with OndansetronEXPERIMENTALParticipants will receive a single SC high dose of 350 mg AMG 133 and ondansetron 8mg ODT every 8 hours for 72 hours.
Group 1 (reference): AMG 133 Concentration A (frozen liquid)EXPERIMENTALParticipants will receive a single dose of AMG 133 as a SC injection.
Group 2 (test): AMG 133 Concentration B (liquid)EXPERIMENTALParticipants will receive a single dose of AMG 133 as a SC injection.
Group 3 (test): AMG 133 Concentration C (liquid)EXPERIMENTALParticipants will receive a single dose of AMG 133 as a SC injection.
AMG 133 Dose AEXPERIMENTALParticipants will receive AMG 133 Dose A SC, followed by subsequent doses of Dose C and Dose D.
AMG 133 Dose BEXPERIMENTALParticipants will receive AMG 133 Dose B SC, followed by subsequent doses of Dose C and Dose D.
AMG 133 Dose CEXPERIMENTALParticipants will receive AMG 133 Dose C SC, followed by subsequent doses of Dose C and Dose D.
Japanese Participants: AMG 133 Low DoseEXPERIMENTALHealthy Japanese participants will receive the low dose of AMG 133 as a SC injection on Day 1 of the study.
Japanese Participants: AMG 133 Medium DoseEXPERIMENTALHealthy Japanese participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.
Japanese Participants: AMG 133 High DoseEXPERIMENTALHealthy Japanese participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.
Caucasian Participants: AMG 133 Medium DoseEXPERIMENTALHealthy Caucasian participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.
Caucasian Participants: AMG 133 High DoseEXPERIMENTALHealthy Caucasian participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.

Interventions

NameTypeDescription
AMG 133DRUGAMG 133 will be administered SC.
PlaceboDRUGPlacebo will be administered SC.
AcetaminophenDRUGAcetaminophen will be administered orally.
OndansetronDRUGOndansetron will be administered via ODT.
AMG 133 (frozen liquid)DRUGAMG 133 will be administered as a SC injection.
AMG 133 (liquid)DRUGAMG 133 will be administered as a SC injection.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female participants between 18 and 65 years of age. a. Females must not be pregnant or lactating. * Body mass index between ≥ 27 to \< 40 kg/m\^2. Exclusion Criteria: * History or evidence of clinically significant disorder, condition, or disease not otherwise exc...

Countries:United States
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMAug 21, 2026NCT07717814TRIAL_REMOVED: changed
MEDIUMAug 21, 2026NCT07717814TRIAL_REMOVED: changed
MEDIUMAug 21, 2026NCT07717814TRIAL_REMOVED: changed
LOWJul 21, 2026NCT07717814NEW_TRIAL: changed

Frequently asked questions about AMG 133

What is AMG 133 used for?

AMG 133 is an investigational small molecule being studied for use in overweight and obesity, as well as in healthy participants and in people with hepatic impairment. It is administered subcutaneously and is currently in Phase 1 clinical development.

Who makes AMG 133?

AMG 133 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 1 clinical trials.

What phase is AMG 133 in?

AMG 133 is in Phase 1 clinical development. It is an investigational drug and is not yet approved by regulatory authorities. All completed trials for AMG 133 are Phase 1 studies.

What clinical trials is AMG 133 in?

AMG 133 has been studied in several completed Phase 1 trials, including NCT05056246 in healthy Japanese and Caucasian participants, NCT07429032 on gastric emptying in overweight or obesity, NCT07429045 on kidney impairment, and NCT07717814 on bioavailability in overweight or obesity.

Is AMG 133 the same as maridebart cafraglutide?

AMG 133 is also known as maridebart cafraglutide. It is an investigational small molecule being developed by Amgen Inc. for overweight and obesity, and it is currently in Phase 1 clinical trials.