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GLP-1 Receptor Agonist

Maridebart Cafraglutide for Diabetes

Phase 2

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 2 diabetes for ≥6 months according to the World Health Organization classification

Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)

Must not have

Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure

Type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

"This trial aims to see how well maridebart cafraglutide helps control glucose levels compared to a placebo."

Who is the study for?

This trial is for adults with Type 2 Diabetes who manage their condition through diet, exercise, or stable doses of metformin. They must be over 18 years old (or the legal age in their country if higher), have a BMI between 23-50 kg/m², and an HbA1c level between 7.0% to 10.5%. People on complex diabetes medication regimens are not eligible.

What is being tested?

The study is testing Maridebart Cafraglutide's effectiveness at controlling blood sugar levels compared to a placebo. Participants will receive either the test drug or a placebo without knowing which one they're getting.

What are the potential side effects?

Potential side effects of Maridebart Cafraglutide may include nausea, low blood sugar events, digestive issues, and possible allergic reactions similar to other diabetes medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had type 2 diabetes for at least 6 months.

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I am at least 18 years old or the legal age in my country.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a major heart event or surgery in the last 3 months and don't have severe heart failure.

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I have Type 1 diabetes.

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I have only used metformin or SGLT2 inhibitors for my diabetes in the last 3 months.

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I haven't had cancer, except for certain skin, cervical, or prostate cancers, in the last 5 years.

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I have unstable diabetic eye problems.

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I have a history of pancreatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Maridebart CafraglutideExperimental Treatment1 Intervention

Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week main treatment period and meet specific criteria will have the option to begin an exploratory part 2 portion where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week main treatment period and meet specific criteria will have the option to begin an exploratory part 2 period where they will receive maridebart cafraglutide for an additional 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Maridebart Cafraglutide

2024

Completed Phase 1

~20

0 / 8Eligibility criteria met