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AMG 133

Phase 3

Hepatic Impairment | Small molecule | Gastrointestinal |Amgen Inc.|Trials Updated: Oct 13, 2026

AMG 133 development status

Highest phase Phase 3 (NCT07575399)
Phase scored for AMGNPhase 1
Registered trials 29 across 1 sponsor since Jul 2020

AMG 133 target and mechanism

ModalitySmall molecule

Also known as AMG 133 (frozen liquid), Maridebart cafraglutide, MariTide

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials29
Total Enrollment32,577

FDA Designations

No designations recorded

AMG 133 clinical trials

AMG 133 · 29 trials · 16 indications

Phase 3 12Phase 2 3Phase 1 14
NCT07866066Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 DiabetesDiabetes Mellitus, Type 2
NOT YET_RECRUITING1,300 Analytics
NCT07871409Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or OverweightObesity
NOT YET_RECRUITING230 Analytics
NCT07684144Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)Obesity
RECRUITING950 Analytics
NCT07684235Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)Obesity
RECRUITING3,200 Analytics
NCT07575399Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)Obesity or Overweight
RECRUITING300 Analytics
NCT07225686Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure TherapyObesity
ACTIVE NOT_RECRUITING250 Analytics
NCT07226765Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) TherapyObstructive Sleep Apnea
ACTIVE NOT_RECRUITING250 Analytics
NCT07037433Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or ObesityAtherosclerotic Cardiovascular Disease
RECRUITING12,800 Analytics
NCT07037459Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and ObesityHeart Failure With Preserved Ejection Fraction
RECRUITING5,056 Analytics
NCT06987695Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity DiseaseObesity Disease
ACTIVE NOT_RECRUITING279 Analytics
PHASE3NOT YET_RECRUITING
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
NCT078660661,300
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PHASE3NOT YET_RECRUITING
Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight
Obesity
NCT07871409230
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PHASE3RECRUITING
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Obesity
NCT07684144950
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PHASE3RECRUITING
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
Obesity
NCT076842353,200
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PHASE3RECRUITING
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
NCT07575399300
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PHASE3ACTIVE NOT_RECRUITING
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Obesity
NCT07225686250
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PHASE3ACTIVE NOT_RECRUITING
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Obstructive Sleep Apnea
NCT07226765250
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PHASE3RECRUITING
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Atherosclerotic Cardiovascular Disease
NCT0703743312,800
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PHASE3RECRUITING
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction
NCT070374595,056
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PHASE3ACTIVE NOT_RECRUITING
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease
Obesity Disease
NCT06987695279
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Study Endpoints

Primary Endpoints

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Baseline to Week 68
Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration
Weeks 12, 16, and 20
Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration
Weeks 12, 16, and 20
Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
Baseline of parent trial (20210184) to Week 48 of current trial
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Baseline of current trial up to 60 weeks
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Baseline of parent trial (20210181) to Week 48 of current trial
Percent Change from Baseline in Body Weight at Week 68
Week 68
Change in Apnea-Hypopnea Index (AHI) from baseline at week 52
At week 52
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE])
Up to approximately 35 months
Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE)
Up to approximately 35 months
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events
Up to approximately 35 months

Heart Failure events include: hospitalization for HF or urgent HF visits.

Percent Change From Baseline in Body Weight at Week 72
Baseline and Week 72
Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72
Baseline and Week 72
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
Baseline and Week 52
Percent Change from Baseline in Body Weight at Week 52
Baseline and Week 52
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Baseline to Week 24
Percent Change From Baseline to Week 52 in Body Weight
Baseline and Week 52
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
Up to Day 120
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide
Up to Day 120
Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide
Up to Day 120
Maximum Observed Concentration (Cmax) of COC
Day 1 up to Day 89
Area Under the Concentration-time Curve (AUC) from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of COC
Day 1 up to Day 89
AUC from Time Zero Extrapolated to Infinity (AUCinf) of COC
Day 1 up to Day 89
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) of AMG 133
Up to Day 120
AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Up to Day 120
Change from Baseline in QTcF for Maridebart Cafraglutide
Up to Day 171

Change from baseline in QTcF for maridebart cafraglutide will be the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QTcF after maridebart cafraglutide dosing.

Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide
Up to Day 120
Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide
Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Up to Day 120
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25
Baseline and Week 25
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
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
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide
Up to approximately 120 days
AUC from Time Zero Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
Up to approximately 120 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Part A: 150 days; Part B: 207 days; Part C Cohort 12: 193 days; Part C Cohort 13: 207 days

A TEAE was defined as any adverse event (AE) which started on or after the first dose of AMG 133. Clinically significant changes in laboratory safety tests, vital signs and 12-lead electrocardiograms (ECGs) were included as AEs.

Secondary Endpoints

Change from Baseline in HbA1c at week 68 [Superiority]
Baseline to Week 68
Percent Change from Baseline in Body Weight at Week 68
Baseline to Week 68
Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Week 68
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Maridebart cafraglutideEXPERIMENTALParticipants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner.
SemaglutideACTIVE_COMPARATORParticipants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner.
Maridebart Cafraglutide Low Dose Q4WEXPERIMENTALParticipants who received low dose of maridebart cafraglutide in the parent trial (20210184 \[NCT06858878\]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks (Q4W).
Maridebart Cafraglutide Medium Dose Q4WEXPERIMENTALParticipants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.
Maridebart Cafraglutide Medium dose Q8WEXPERIMENTALParticipants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8 weeks (Q8W).
Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)PLACEBO_COMPARATORParticipants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Maridebart Cafraglutide High Dose Q4WEXPERIMENTALParticipants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.
Maridebart Cafraglutide High Dose Q8WEXPERIMENTALParticipants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.
Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)PLACEBO_COMPARATORParticipants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)EXPERIMENTALParticipants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.
Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)EXPERIMENTALParticipants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.
Maridebart Cafraglutide High Dose Q12WEXPERIMENTALParticipants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC once in 12 weeks (Q12W).
MariTide Arm 1EXPERIMENTALParticipants will receive maridebart cafraglutide dosing schedule 1 during the treatment period.
MariTide Arm 2EXPERIMENTALParticipants will receive maridebart cafraglutide dosing schedule 2 during the treatment period.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo SC.
Maridebart Cafraglutide High DoseEXPERIMENTALParticipants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Maridebart Cafraglutide Medium DoseEXPERIMENTALParticipants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Maridebart Cafraglutide Low DoseEXPERIMENTALParticipants will receive maridebart cafraglutide low dose SC for 72 weeks.
Cohort A: Maridebart CafraglutideEXPERIMENTALPart 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Cohort A: PlaceboPLACEBO_COMPARATORPart 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts . Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Cohort B: Maridebart CafraglutideEXPERIMENTALPart 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Cohort B: PlaceboPLACEBO_COMPARATORPart 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.
Maridebart Cafraglutide (Test)EXPERIMENTALParticipants will receive maridebart cafraglutide (test formulation) via subcutaneous (SC) injection.
Maridebart Cafraglutide (Reference)ACTIVE_COMPARATORParticipants will receive maridebart cafraglutide (reference formulation) via SC injection.
COC + Maridebart CafraglutideEXPERIMENTALParticipants will receive COC orally and maridebart cafraglutide subcutaneously (SC).
Maridebart Cafraglutide SC Presentation 1EXPERIMENTALParticipants will receive a single dose of maridebart cafraglutide administered using SC presentation 1.
Maridebart Cafraglutide SC Presentation 2ACTIVE_COMPARATORParticipants will receive a single dose of maridebart cafraglutide administered using SC presentation 2.
Group 1EXPERIMENTALIn treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.
Group 2AEXPERIMENTALIn treatment period 1, participants will receive moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.
Group 2BEXPERIMENTALIn treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive moxifloxacin.
AMG 133EXPERIMENTALParticipants will receive AMG 133 subcutaneously (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.
Group 1: Maridebart Cafraglutide Dose 1EXPERIMENTALParticipants will receive a single SC lower dose of Maridebart Cafraglutide.
Group 2: Maridebart Cafraglutide Dose 2EXPERIMENTALParticipants will receive a single SC higher dose of Maridebart Cafraglutide.
Part A: maridebart cafraglutideEXPERIMENTALUp to 7 single ascending dose cohorts (cohorts 1 to 6 and cohort 11).
Part A: PlaceboPLACEBO_COMPARATORUp to 7 single ascending dose cohorts (cohorts 1 to 6 and cohort 11).
Part B: maridebart cafraglutideEXPERIMENTALUp to 4 multiple ascending dose cohorts (cohorts 7 to 10).
Part B: PlaceboPLACEBO_COMPARATORUp to 4 multiple ascending dose cohorts (cohorts 7 to 10).
Part C: maridebart cafraglutideEXPERIMENTALUp to 2 open-label, multiple ascending dose cohorts (cohorts 12 to 13) treated with doses previously studied in Part A and Part B.

Interventions

NameTypeDescription
Maridebart cafraglutideDRUGAdministered subcutaneously.
SemaglutideDRUGAdministered subcutaneously.
AutoinjectorDEVICEThe AI will be used by participants to self-administer SC doses of maridebart cafraglutide.
PlaceboDRUGAdministered subcutaneously.
COCDRUGAdministered orally.
MoxifloxacinDRUGParticipants will receive moxifloxacin orally.
Placebo for Maridebart CafraglutideDRUGParticipants will receive placebo for maridebart cafraglutide SC.
Placebo for MoxifloxacinDRUGParticipants will receive placebo for moxifloxacin orally.
AMG 133DRUGAMG 133 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening. * Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose co...

Countries:United StatesCanadaJapanPuerto RicoUnited KingdomAustraliaBrazilCzechiaFranceGermanyHungaryPolandSpainArgentinaAustriaBelgiumBulgariaChileChinaColombiaDenmarkFinlandGreeceHong KongItalyMexicoNetherlandsPortugalRomaniaSingaporeSlovakiaSouth KoreaSwedenSwitzerlandTaiwanTurkey (Türkiye)
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Recent Changes (Last 90 Days)

LOWOct 13, 2026NCT07871409NEW_TRIAL: changed
LOWOct 13, 2026NCT07871409NEW_TRIAL: changed
LOWOct 8, 2026NCT07866066NEW_TRIAL: changed
LOWOct 8, 2026NCT07575399lastUpdatePostDate: changed
LOWOct 8, 2026NCT07037433lastUpdatePostDate: changed
LOWOct 8, 2026NCT07866066NEW_TRIAL: changed
LOWOct 8, 2026NCT07575399lastUpdatePostDate: changed
LOWOct 8, 2026NCT07037433lastUpdatePostDate: changed
LOWOct 6, 2026NCT07225686primaryCompletionDate: changed
LOWOct 6, 2026NCT07225686primaryCompletionDate: changed
LOWOct 5, 2026NCT07684144lastUpdatePostDate: changed
LOWOct 5, 2026NCT07684235lastUpdatePostDate: changed
LOWOct 5, 2026NCT07037433lastUpdatePostDate: changed
LOWOct 5, 2026NCT07684144lastUpdatePostDate: changed
LOWOct 5, 2026NCT07684235lastUpdatePostDate: changed
LOWOct 5, 2026NCT07037433lastUpdatePostDate: changed
MEDIUMSep 29, 2026NCT07226765Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMSep 29, 2026NCT07226765Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about AMG 133

What is AMG 133?

AMG 133 is an investigational small molecule developed by Amgen Inc. (NASDAQ: AMGN) for overweight and obesity, including overweight or obesity with hepatic impairment. It is in Phase 1 clinical development and has been studied in trials focused on bioavailability, drug absorption and elimination, and gastric emptying in participants with overweight or obesity.

What is AMG 133 used for?

AMG 133 is being developed for overweight and obesity, including overweight or obesity in people with hepatic impairment. Amgen Inc. (NASDAQ: AMGN) has completed Phase 1 studies in these populations. It is investigational and has not been approved for any indication.

Who makes AMG 133?

AMG 133 is developed by Amgen Inc., which trades on NASDAQ under the ticker AMGN. Amgen is the sponsor of the Phase 1 clinical program evaluating AMG 133 in overweight and obesity and in participants with hepatic impairment.

What phase is AMG 133 in?

AMG 133 is in Phase 1 clinical development. All four listed trials are Phase 1 studies and are completed, with no active trials currently listed. AMG 133 is investigational and has not been approved by the FDA for any indication.

What clinical trials is AMG 133 in?

AMG 133 has been evaluated in completed Phase 1 trials including NCT07717814, a bioavailability study in overweight or obesity; NCT07429045, a kidney impairment study; NCT07429032, a gastric emptying study; and NCT07428525, a hepatic impairment study. Total enrollment across these trials was 198 participants.

Is AMG 133 the same as AMG 133 (frozen liquid)?

Yes. AMG 133 (frozen liquid) refers to the same investigational drug as AMG 133, developed by Amgen Inc. (NASDAQ: AMGN). The frozen liquid description refers to the drug's formulation, and both names point to the same Phase 1 small molecule program in overweight and obesity.

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