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Maridebart cafraglutide

Phase 3

Obstructive Sleep Apnea | Small molecule | Respiratory |Amgen Inc.|Last Updated: Jul 16, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical trial landscape

Maridebart cafraglutide · 19 trials · 14 indications

Phase 3 10Phase 2 3Phase 1 6
NCT07684235Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)Obesity
NOT YET_RECRUITING3,200 Analytics
NCT07684144Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)Obesity
NOT YET_RECRUITING950 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
RECRUITING250 Analytics
NCT07226765Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) TherapyObstructive Sleep Apnea
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
NCT06858878Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightType 2 Diabetes Mellitus (T2DM), Obesity, Overweight
ACTIVE NOT_RECRUITING1,105 Analytics
NCT06858839Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightObesity
ACTIVE NOT_RECRUITING3,853 Analytics
PHASE3NOT YET_RECRUITING
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
Obesity
NCT076842353,200
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PHASE3NOT YET_RECRUITING
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Obesity
NCT07684144950
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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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PHASE3RECRUITING
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Obesity
NCT07225686250
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PHASE3RECRUITING
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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PHASE3ACTIVE NOT_RECRUITING
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
NCT068588781,105
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PHASE3ACTIVE NOT_RECRUITING
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Obesity
NCT068588393,853
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Study Endpoints
Primary Endpoints
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Baseline of parent trial (20210181) 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 (20210184)
Baseline of parent trial (20210184) to Week 48 of current trial
Percent Change from Baseline in Body Weight at Week 68
Week 68
Change in AHI from baseline at week 52
At Week 52
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 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
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
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline of the Parent Trial
Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline of the Parent Trial
Baseline of parent trial to Week 48 of current trial
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Maridebart Cafraglutide Low Dose Q4WEXPERIMENTALParticipants who received low dose of maridebart cafraglutide in the parent trial (20210181 \[NCT06858839\]) 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 8weeks (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.
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).
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.
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.
Maridebart CafraglutideEXPERIMENTALParticipants will receive maridebart cafraglutide subcutaneously (SC).
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 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.
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
PlaceboDRUGAdministered subcutaneously.
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.
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Eligibility Criteria
Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Completed the parent trial (2010181) * Completed week 72 visit in parent trial * Did not permanently discontinue trial intervention in ...

Countries:United StatesPuerto RicoAustraliaBrazilCanadaCzechiaFranceGermanyHungaryJapanPolandSpainArgentinaAustriaBelgiumBulgariaChileChinaColombiaDenmarkFinlandGreeceHong KongItalyMexicoNetherlandsPortugalRomaniaSingaporeSlovakiaSouth KoreaSwedenSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
MEDIUMJul 18, 2026NCT07226778TRIAL_REMOVED: changed
MEDIUMJul 18, 2026NCT07226778TRIAL_REMOVED: changed
MEDIUMJul 18, 2026NCT07226778TRIAL_REMOVED: changed
HIGHJul 17, 2026NCT07313761Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 17, 2026NCT07313761Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 17, 2026NCT07313761Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJul 10, 2026NCT07037433lastUpdatePostDate: changed
LOWJul 10, 2026NCT07037433lastUpdatePostDate: changed
LOWJul 6, 2026NCT07684144NEW_TRIAL: changed
LOWJul 6, 2026NCT07684235NEW_TRIAL: changed
LOWJul 6, 2026NCT07684144NEW_TRIAL: changed
LOWJul 6, 2026NCT07684235NEW_TRIAL: changed
LOWJul 2, 2026NCT07575399lastUpdatePostDate: changed
LOWJul 2, 2026NCT07037459lastUpdatePostDate: changed
LOWJul 2, 2026NCT07575399lastUpdatePostDate: changed
LOWJul 2, 2026NCT07037459lastUpdatePostDate: changed
LOWJun 18, 2026NCT07441252lastUpdatePostDate: changed
LOWJun 18, 2026NCT07037433lastUpdatePostDate: changed
HIGHJun 18, 2026NCT07226778Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJun 18, 2026NCT07441252lastUpdatePostDate: changed