Maridebart Cafraglutide

Phase 3Peptide

Amgen

Maridebart Cafraglutide is one of 208 small molecule programs targeting Obesity. It is currently in Phase 3.

Indications

Total Trials

Active Trials

207

Competitors

Pipeline

Status by Indication[3][1]

Indication

ObesityActive, not recruiting

Obesity or OverweightRecruiting

Atherosclerotic Cardiovascular DiseaseRecruiting

ARTActive, not recruiting

HeartActive, not recruiting

OverweightRecruiting

Type 2 Diabetes MellitusActive, not recruiting

Obstructive Sleep ApneaRecruiting

ObesityPhase 3

Active, not recruiting

Obesity or OverweightPhase 3

Recruiting

Atherosclerotic Cardiovascular DiseasePhase 3

Recruiting

ARTPhase 1

Active, not recruiting

HeartPhase 1

Active, not recruiting

OverweightPhase 2

Recruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Obstructive Sleep ApneaPhase 3

Recruiting

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Vivia

SSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Phase 3

1 2

Maridebart Cafraglutide

Amgen

Phase 3

7 3

NNC0487-0111

Novo Nordisk

Phase 3

11 4

IBI362

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

4 5

Zenagamtide

Novo Nordisk

Phase 3

3 6

Berobenatide

Pfizer

Phase 3

3 7

Eloralintide

Eli Lilly

Phase 3

10 8

PF-08653944

Pfizer

Phase 3

5 9

Efsubaglutide Alfa

SShanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Phase 3

1 10

Aleniglipron

GGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Phase 3

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

Q2 2027

Phase 3Active, not recruiting

Type 2 Diabetes Mellitus

NCT06858878

Phase 3Active, not recruiting

Obesity

NCT06858839

Q3 2027

Phase 3Active, not recruiting

Obesity

NCT06987695

Clinical

Trials by Indication[1]

Obesity7 trials

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

Completed· Amgen logo

Amgen·Phase 1·NCT04478708·110 enrolled

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

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

Show 4 more trials

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 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, 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

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

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

Overweight2 trials

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

Completed· Amgen logo

Amgen·Phase 1·NCT06352892·20 enrolled

A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight

Recruiting· Amgen logo

Amgen·Phase 2·NCT07441252·180 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

Heart1 trial

Effect of Maridebart Cafraglutide on the Heart's Electrical Activity

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT07229157·81 enrolled

6 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

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

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

Recruiting· Amgen logo

Amgen·Phase 3·NCT07037433·12,800 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

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)

Recruiting· Amgen logo

Amgen·Phase 3·NCT07226765·250 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 — 20 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

Q2 2027

Q3 2027

Trials by Indication[1]

Obesity7 trials

Type 2 Diabetes Mellitus3 trials

Overweight2 trials

ART1 trial

Heart1 trial

Heart Failure With Preserved Ejection Fraction1 trial

Type 2 Diabetes Mellitus (T2DM)1 trial

Atherosclerotic Cardiovascular Disease1 trial

Obesity or Overweight1 trial

Obstructive Sleep Apnea1 trial

Overweight and Obesity1 trial

References

Drug Info

Quick Facts

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