Maridebart Cafraglutide for Diabetes

Recruiting at 97 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.

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.

What data supports the effectiveness of the drug Maridebart Cafraglutide for diabetes?

Research on similar drugs like liraglutide, which is a GLP-1 analog, shows that they can effectively lower blood sugar levels and help with weight loss in people with type 2 diabetes. These drugs are generally safe and have a low risk of causing low blood sugar when used alone. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Maridebart Cafraglutide (GLP-1 Receptor Agonist)

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.

Participant Groups

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 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: 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 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.

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

The importance of patient-reported outcomes in type 2 diabetes: insight from the PIONEER program with oral semaglutide. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacology, efficacy and safety of liraglutide in the management of type 2 diabetes. [2021]