Maridebart Cafraglutide for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must be taking: Metformin

Must not be taking: GLP-1RA, Antidepressants, Antipsychotics, others

Disqualifiers: Type 1 diabetes, Cancer, Heart disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 25 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called maridebart cafraglutide for individuals with Type 2 Diabetes. The main aim is to assess its effect on insulin sensitivity compared to a placebo. It targets those who have had Type 2 Diabetes for at least six months, are managing it with metformin, and have a body mass index (BMI) between 27 and 45. Participants will receive either the experimental treatment or a placebo, both administered as an injection under the skin. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of metformin, and they may also be on one additional oral diabetes medication. However, you cannot use certain medications, supplements, or remedies for weight loss, or medications that may cause significant weight gain, within 90 days before joining the trial.

Is there any evidence suggesting that maridebart cafraglutide is likely to be safe for humans?

Research has shown that maridebart cafraglutide underwent testing in earlier studies for safety. In one study, participants did not experience unexpected safety problems, suggesting the treatment is generally well-tolerated.

Another study found that maridebart cafraglutide significantly aided weight loss in people with obesity. Although weight loss was the primary goal, the study also assessed safety and found no major safety issues.

As this current trial is in its early stage, the main focus is on understanding the treatment's safety for participants. While information is limited, existing studies offer some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Type 2 diabetes, which often include oral medications like metformin or insulin injections, Maridebart Cafraglutide is unique because it is administered subcutaneously and may offer a novel mechanism of action. Researchers are excited about this treatment because it could provide more effective blood sugar control with potentially fewer side effects. Additionally, its unique delivery method might enhance patient adherence and convenience compared to daily pills or multiple insulin injections. This innovative approach has the potential to significantly improve the quality of life for people managing Type 2 diabetes.

What evidence suggests that maridebart cafraglutide might be an effective treatment for Type 2 Diabetes?

Research has shown that maridebart cafraglutide, which participants in this trial may receive, may help manage Type 2 diabetes and obesity. In earlier studies, individuals with obesity and Type 2 diabetes lost up to 17% of their body weight. This weight loss also improved their blood sugar levels, which is crucial for controlling diabetes. The treatment mimics a hormone that regulates appetite and blood sugar. These early findings suggest that maridebart cafraglutide might enhance insulin use in people with Type 2 diabetes. ^{2 3 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for individuals with Type 2 Diabetes Mellitus who are currently managing their condition with a stable dose of metformin. Specific eligibility criteria have not been provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

Informed consent before initiation of any study-specific activities/procedures

Body mass index 27 ≥ and ≤ 45 kg/m^2 at screening

I am between 18 and 70 years old.

Exclusion Criteria

One or more episodes of severe hypoglycemia (Level 3 hypoglycemia as defined by the American Diabetes Association classification criteria) within 6 months before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery

Has modified diet or adopted any nutritional lifestyle modifications within 3 months prior to screening, as assessed by the investigator (or designee) based on participant self-report

Positive human immunodeficiency virus test at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maridebart cafraglutide or placebo subcutaneously

25 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maridebart Cafraglutide

Trial Overview The study is testing the effects of Maridebart cafraglutide compared to a placebo on insulin sensitivity in people with Type 2 Diabetes. Participants will either receive the investigational drug or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Maridebart cafraglutide Experimental Treatment 1 Intervention

Participants will receive maridebart cafraglutide subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2504214

Once-Monthly Maridebart Cafraglutide for the Treatment ... Participants with obesity and type 2 diabetes had a mean weight reduction of up to 12.3% (treatment policy estimand), accompanied by a mean ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06660173

NCT06660173 | A Study of Maridebart Cafraglutide in Adult ... The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.

3. amgen.com amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions

RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ... In the Phase 2 study, MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D) compared ...

4. diabetes.org diabetes.org/newsroom/press-releases/new-formulations-glp-1s-demonstrate-positive-results-potentially-offering

New Formulations of GLP-1s Demonstrate Positive Results ... Results demonstrated a weight loss of up to approximately 20% on average in participants with obesity alone and a weight loss and A1C reduction ...

5. ajmc.com ajmc.com/view/weight-loss-drug-maridebart-cafraglutide-shows-efficacy-in-phase-2-trial

Weight-Loss Drug Maridebart Cafraglutide Shows Efficacy ... Maridebart cafraglutide showed up to 19.9% weight loss in obesity and 17% in obesity-diabetes patients in a phase 2 trial. The drug's 21-day ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06858878

Study Details | NCT06858878 | Efficacy and Safety of ... Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2).

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40549887/

Once-Monthly Maridebart Cafraglutide for the Treatment of ... No unexpected safety signals emerged. Conclusions: In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight ...

8. amgentrials.com amgentrials.com/study/?id=20230143

AMGEN - A Study of Maridebart Cafraglutide in Adult ... The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.