Maridebart Cafraglutide for Diabetes

Not currently recruiting at 125 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Must be taking: Metformin, SGLT2 inhibitors

Must not be taking: Glucose-lowering medications

Disqualifiers: Type 1 diabetes, Pancreatitis, Cardiovascular events, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests maridebart cafraglutide to determine its effectiveness in controlling blood sugar levels in people with type 2 diabetes. Researchers aim to identify the optimal dose of the treatment compared to a placebo (a pill with no active drug). Participants will receive different doses or a placebo for 24 weeks, with some continuing the treatment for an additional 24 weeks. This trial suits individuals with type 2 diabetes who have managed it with diet, exercise, and possibly metformin for at least three months. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are taking medications other than metformin or a sodium-glucose cotransporter-2 inhibitor for diabetes, you will need to stop them at least 3 months before joining the trial. The trial allows the use of metformin and certain other diabetes medications, but not others.

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

Research has shown that maridebart cafraglutide has been tested in earlier studies for its effects on weight loss. In one study, individuals with obesity who did not have Type 2 diabetes lost an average of about 20% of their weight. Another study found that those with both obesity and Type 2 diabetes lost around 12.3% of their weight.

Regarding safety, these studies did not identify any major safety issues with maridebart cafraglutide. As this treatment remains in Phase 2 trials, researchers are primarily working to determine the right dose and are closely monitoring for any side effects. It is important to understand that while this phase includes a detailed safety review, further studies are often needed to fully confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetes?

Maridebart cafraglutide is unique because it offers a fresh approach to managing diabetes by potentially providing improved glucose control through a novel mechanism. Unlike current standard treatments like metformin or insulin, which primarily focus on regulating blood sugar levels, maridebart cafraglutide targets the body’s metabolic pathways differently. This investigational drug is designed to enhance insulin sensitivity and may also provide additional benefits in weight management, making it a promising option for those looking to address both glucose levels and weight concerns simultaneously. Researchers are excited about this treatment because it could offer a more comprehensive solution to managing diabetes, addressing multiple aspects of the condition in one go.

What evidence suggests that maridebart cafraglutide might be an effective treatment for diabetes?

Research has shown that maridebart cafraglutide can significantly aid in weight loss for people with type 2 diabetes. Specifically, participants who were obese and had type 2 diabetes lost up to 12.3% of their body weight. Additionally, maridebart cafraglutide has been linked to lower A1C levels, indicating better long-term blood sugar control. In this trial, participants will receive maridebart cafraglutide at varying dose levels or a placebo for up to 24 weeks. These findings suggest that maridebart cafraglutide could effectively manage both blood sugar and weight in people with diabetes, highlighting its potential as a promising treatment option. ^{3 6 7 8 9}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory

I manage my diabetes with diet, exercise, and possibly metformin or SGLT2 inhibitors.

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

Exclusion Criteria

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

I have Type 1 diabetes.

Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation

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 for up to 24 weeks to assess dose-response on glucose control

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Exploratory Part 2

Participants who meet specific criteria may receive maridebart cafraglutide for an additional 24 weeks

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maridebart Cafraglutide

Trial Overview 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.

How Is the Trial Designed?

Group I: Maridebart Cafraglutide Experimental Treatment 1 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 Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.

Group II: Placebo Placebo Group 1 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 Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.

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

Published Research Related to This Trial

Oral semaglutide, the first oral GLP-1 receptor agonist approved in 2019, showed significant improvements in patient-reported outcomes (PROs) such as general health and mental health compared to placebo in the PIONEER clinical study program involving patients with type 2 diabetes.

While oral semaglutide generally performed similarly to other treatments like empagliflozin, it specifically improved patient satisfaction regarding blood sugar levels and craving control, highlighting its potential to enhance the overall treatment experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of patient-reported outcomes in type 2 diabetes: insight from the PIONEER program with oral semaglutide. Schneider, D., Taddei-Allen, P., Dougherty, T.[2021]

Long-acting GLP-1 receptor agonists (GLP-1RAs) like dulaglutide and semaglutide can reduce A1C levels by 1% to 1.5%, with some studies showing reductions close to 2%, making them effective treatments for type 2 diabetes.

These medications have a low risk of hypoglycemia due to their glucose-dependent action and have been shown to be safe, not increasing cardiovascular risk, while also promoting weight loss and improving patient adherence with convenient dosing options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting GLP-1RAs: An overview of efficacy, safety, and their role in type 2 diabetes management. Chun, JH., Butts, A.[2021]

Liraglutide is an effective once-daily treatment for type 2 diabetes, showing significant reductions in hemoglobin A1c and body weight, with a low risk of hypoglycemia when used alone.

While generally safe, liraglutide can cause dose-dependent nausea, vomiting, and diarrhea, and further monitoring is needed to assess potential risks of pancreatitis and medullary thyroid carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology, efficacy and safety of liraglutide in the management of type 2 diabetes. Neumiller, JJ., Sonnett, TE., Wood, LD., et al.[2021]

Liraglutide, a GLP-1 analog approved for type 2 diabetes, effectively reduces hemoglobin A1c and body weight with a low risk of hypoglycemia, making it a safe treatment option.

Clinical studies over two years show that liraglutide is well tolerated, with common side effects being mild nausea and diarrhea, and it offers better improvements in glycemic control compared to other diabetes medications like exenatide and sitagliptin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide for the treatment of type 2 diabetes: a clinical update. Peters, KR.[2022]

Exenatide effectively lowers fasting plasma glucose and HbA1c levels in type 2 diabetes patients who are not adequately controlled on other medications, working through mechanisms like enhancing insulin secretion and reducing glucagon levels.

The most common side effects of exenatide are nausea and vomiting, but the risk of acute pancreatitis appears to be similar to that of the general population with type 2 diabetes, suggesting it is relatively safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide: clinical aspects of the first incretin-mimetic for the treatment of type 2 diabetes mellitus. Wajcberg, E., Tavaria, A.[2019]

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. investors.amgen.com investors.amgen.com/news-releases/news-release-details/results-amgens-phase-2-obesity-study-monthly-maritide-presented

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 ...

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

Once-Monthly Maridebart Cafraglutide for the Treatment of ... In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05669599

NCT05669599 | Dose-ranging Study to Evaluate the ... The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight ...

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

New Formulations of GLP-1s Demonstrate Positive Results ... Findings from the MariTide Phase 2 Trial demonstrating weight loss and A1C reduction in groups with and without type 2 diabetes were presented ...

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

Study Details | NCT06858878 | Efficacy and Safety of ... The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight. Official Title. A ...

7. 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 ...

8. medicine.yale.edu medicine.yale.edu/news-article/once-monthly-obesity-medication-shows-promise-for-those-with-and-without-type-2-diabetes/

Once-Monthly Obesity Medication Shows Promise for Those ... Researchers found maridebart cafraglutide (MariTide) was effective at reducing weight in patients with obesity with just once-monthly doses.

9. amgentrials.com amgentrials.com/study/?id=20190218

AMGEN - Dose-ranging Study to Evaluate the Efficacy, ... The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining ...