Maridebart Cafraglutide

Phase 3Peptide

Maridebart Cafraglutide is one of 132 small molecule programs targeting Type 2 Diabetes Mellitus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

131

Competitors

Pipeline

Status by Indication[3][1]

Indication

Type 2 Diabetes MellitusActive, not recruiting

ObesityActive, not recruiting

ARTActive, not recruiting

Obesity or OverweightRecruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

ObesityPhase 3

Active, not recruiting

ARTPhase 1

Active, not recruiting

Obesity or OverweightPhase 3

Recruiting

Competition

Competitive Landscape

177 competitors in Obesity

#DrugCompanyPhaseTrials

Enavogliflozin

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 2

Maridebart Cafraglutide

Amgen

Phase 3

11 3

Berobenatide

Pfizer

Phase 3

6 4

HRS9531

FFujian Shengdi Pharmaceutical Co., Ltd.

Phase 3

1 5

NNC0487-0111

Novo Nordisk

Phase 3

11 6

Cagrisema

Novo Nordisk

Phase 3

5 7

Eloralintide

Eli Lilly

Phase 3

13 8

Belantamab Mafodotin-Blmf

Novo Nordisk

Phase 3

1 9

Semaglutide or Tirzepatide

NNational and Kapodistrian University of Athens

Phase 3

1 10

Actemra

Roche

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Type 2 Diabetes Mellitus (T2DM)

NCT06660173

Phase 1Active, not recruiting

Obesity

NCT07523711

Phase 1Recruiting

Type 2 Diabetes Mellitus

NCT07160257

Q1 2027

Phase 1Not yet recruiting

Obesity

NCT07832799

Q2 2027

Phase 3Active, not recruiting

Type 2 Diabetes Mellitus

NCT06858878

Phase 3Active, not recruiting

Obesity

NCT06858839

Clinical

Trials by Indication[1]

Obesity11 trials

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT06987695·279 enrolled

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

Completed· Amgen logo

Amgen·Phase 1·NCT04478708·110 enrolled

A Phase 1, Randomized, Double-blind, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Maridebart Cafraglutide After Switching From Glucagon-like Peptide-1 Receptor Agonists in Participants Living With Overweight or Obesity

Recruiting· Amgen logo

Amgen·Phase 1·NCT07908316·180 enrolled

Show 8 more trials

A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus

Not yet recruiting· Amgen logo

Amgen·Phase 3·NCT07871409·230 enrolled

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living With Overweight or Obesity

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT07225686·250 enrolled

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus

Recruiting· Amgen logo

Amgen·Phase 3·NCT07684144·950 enrolled

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight

Recruiting· Amgen logo

Amgen·Phase 3·NCT07684235·3,200 enrolled

A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, Parallel Group Study With Nested Crossover Comparison to Assess the Effect of Maridebart Cafraglutide on QT/QTc Intervals in Participants Living With Overweight or Obesity

Completed· Amgen logo

Amgen·Phase 1·NCT07229157·81 enrolled

A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Maridebart Cafraglutide (AMG 133) Drug Products in Participants Living With Overweight or Obesity

Not yet recruiting· Amgen logo

Amgen·Phase 1·NCT07832799·340 enrolled

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT06858839·3,853 enrolled

A Phase 1, Open-label Study to Assess the Effect of Maridebart Cafraglutide (AMG 133) on the Pharmacokinetics of Oral Contraceptives in Postmenopausal Female Participants Living With Overweight or Obesity

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT07523711·49 enrolled

Type 2 Diabetes Mellitus3 trials

A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

Recruiting· Amgen logo

Amgen·Phase 1·NCT07160257·70 enrolled

Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

Completed· Amgen logo

Amgen·Phase 2·NCT05669599·592 enrolled

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT06858878·1,105 enrolled

ART1 trial

Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) Presentations

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT07226778·348 enrolled

Overweight1 trial

A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight

Completed· Amgen logo

Amgen·Phase 1·NCT06352892·20 enrolled

Atherosclerotic Cardiovascular Disease1 trial

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT07037433·12,800 enrolled

7 more indications

Heart Failure With Preserved Ejection Fraction1 trial

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)

Recruiting· Amgen logo

Amgen·Phase 3·NCT07037459·5,056 enrolled

Obesity or Overweight1 trial

A Phase 3, Open-label Trial to Evaluate the Efficacy, Safety and Tolerability of Switching From the Glucagon-like Peptide-1 Receptor Agonists to Maridebart Cafraglutide in Adult Participants With Obesity or Overweight

Recruiting· Amgen logo

Amgen·Phase 3·NCT07575399·300 enrolled

Diabetes Mellitus, Type 21 trial

A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes

Not yet recruiting· Amgen logo

Amgen·Phase 3·NCT07866066·1,300 enrolled

Obstructive Sleep Apnea1 trial

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT07226765·250 enrolled

Overweight or Obesity1 trial

Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight

Active, not recruiting· Amgen logo

Amgen·Phase 2·NCT07441252·180 enrolled

Type 2 Diabetes Mellitus (T2DM)1 trial

A Study to Evaluate the Efficacy, Safety & Tolerability of Maridebart Cafraglutide in Adults With T2DM

Active, not recruiting· Amgen logo

Amgen·Phase 2·NCT06660173·409 enrolled

Overweight and Obesity1 trial

A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity

Completed· Amgen logo

Amgen·Phase 1·NCT07313761·349 enrolled

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Maridebart Cafraglutide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Maridebart Cafraglutide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Maridebart Cafraglutide. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Highest Phase: Phase 3[1]
Company: Amgen

Maridebart Cafraglutide

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Obesity11 trials

Type 2 Diabetes Mellitus3 trials

ART1 trial

Overweight1 trial

Atherosclerotic Cardiovascular Disease1 trial

Heart Failure With Preserved Ejection Fraction1 trial

Obesity or Overweight1 trial

Diabetes Mellitus, Type 21 trial

Obstructive Sleep Apnea1 trial

Overweight or Obesity1 trial

Type 2 Diabetes Mellitus (T2DM)1 trial

Overweight and Obesity1 trial

References

Drug Info

Quick Facts

Related News