Active not recruitingPHASE3INTERVENTIONAL

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

This research study is testing a new medication called maridebart cafraglutide. It's designed for adults living with type 2 diabetes who are also overweight or have obesity. Researchers want to find out if this new medicine can help people lose weight more effectively than a placebo, which is a dummy treatment with no active ingredients. The study will compare the effects of maridebart cafraglutide against the placebo to see how much body weight changes. This is a "Phase 3" study, meaning it's one of the final stages of testing before a medicine might be considered for wider use. It's an important step in finding new ways to manage both type 2 diabetes and obesity.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

1,105

Start

17 Mar 2025

Estimated completion

16 Apr 2027

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

What is this study about?

This study is looking at a new medicine called 'maridebart cafraglutide' for adults who have type 2 diabetes and are also carrying extra weight, either being overweight or having obesity. Many people with type 2 diabetes find it challenging to manage their weight, which can make their diabetes harder to control.

The main aim of this research is to see if maridebart cafraglutide can help people lose weight better than a dummy treatment (a placebo). A placebo looks just like the real medicine but has no active ingredients. By comparing the new medication to a placebo, doctors can understand if the new drug itself is causing any changes they see.

This is a 'Phase 3' study, which means the medication has already been tested in smaller groups of people and shown some promising results. Now, it's being tested in a larger group to make sure it's safe and effective before it could potentially be made available to more people. Finding new ways to help manage weight for people with type 2 diabetes could lead to better health outcomes overall.

Key takeaways

This study is for adults with type 2 diabetes who are overweight or have obesity.
It tests a new medicine called maridebart cafraglutide for weight loss.
Participants will receive either the new medicine or a dummy treatment (placebo).
The study aims to see if the new medicine works better for weight loss than the placebo.
Your health will be closely watched throughout the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older. You must also have type 2 diabetes and have a body mass index (BMI) of 27 or higher, which means you are considered overweight or to have obesity. You should have also tried to lose weight through diet and exercise at least once without success.

There are certain reasons why you might not be able to join. For example, if you have type 1 diabetes, or have had a big change in your weight (more than 5 kg) in the last three months, you wouldn't be able to take part. Also, if you have certain eye problems linked to diabetes that need urgent treatment, or if your obesity is caused by other hormone issues, you would not be eligible.

Other reasons you might not be able to join include a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related condition called Multiple Endocrine Neoplasia syndrome type 2. A recent history of severe problems with your pancreas or certain severe mental health conditions, including a past suicide attempt, would also prevent you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with type 2 diabetes?
Is your body mass index (BMI) 27 or higher?
Have you tried losing weight with diet and exercise before, without success?
Do you have type 1 diabetes? (If yes, you likely can't join)
Have you had a major change in your weight (more than 5 kg) in the last 3 months? (If yes, you likely can't join)

Answer every question to see your result.

What does participation involve?

If you join this study, you would be asked to take either the new study medication (maridebart cafraglutide) or a placebo (dummy treatment). You wouldn't know which one you're taking, nor would the study doctors, until the study is over. You'll have regular visits to the clinic where the study team will monitor your health, take measurements like your weight, and ask about any changes you notice. These visits will involve various health checks and possibly blood tests.

You would take the study medication as instructed for a set period. Throughout the study, the team will keep a close eye on your health and any side effects. After you finish taking the medication, there will be follow-up appointments to make sure you're doing well. The total duration of your involvement in the study, including all visits and follow-ups, would be explained in detail by the study team.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new medication that could help manage your weight and potentially improve your type 2 diabetes. However, there's also a chance you could receive the placebo and not the active drug. As with any medication, there are potential risks and side effects, which the study team would explain in full detail. Your health will be carefully monitored throughout the study. Remember, joining is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (187)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Alliance for Multispecialty Research Mobile
Verified postcode
Mobile, United States
Gilbert Center for Family Medicine
Verified postcode
Gilbert, United States
Desert Clinical Research
Verified postcode
Mesa, United States
Avacare Foothills Research Center
Verified postcode
Phoenix, United States
San Fernando Valley Health Institute
Verified postcode
Canoga Park, United States
Core Healthcare Group
Verified postcode
Cerritos, United States
Velocity Clinical Research Chula Vista
Verified postcode
Chula Vista, United States
Headlands Research California
Verified postcode
Escondido, United States
Paradigm Clinical Research
Verified postcode
Modesto, United States
Flourish Research
Verified postcode
Northridge, United States
University of California Irvine
Verified postcode
Orange, United States
Empire Clinical Research
Verified postcode
Pomona, United States

Common questions

What is the main goal of this study?

The main goal is to see if a new medicine, maridebart cafraglutide, helps adults with type 2 diabetes lose weight more than a dummy treatment.

Who can take part in this study?

Adults aged 18 or over with type 2 diabetes, who are overweight or have obesity (BMI of 27 or higher), and have tried to lose weight before without success.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the study medication but has no active ingredients. It helps researchers see if the real medicine is actually working.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study doctors will know if you're taking the study medicine or the placebo until the end of the study.

Can I leave the study at any time?

Yes, taking part is completely your choice, and you can withdraw from the study at any time without it affecting your usual medical care.