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1300 Participants NeededMy employer runs this trial

Maridebart Cafraglutide vs Semaglutide for Type 2 Diabetes

(MARITIME-T2D-3 Trial)

Recruiting at 7 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Amgen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who have a BMI of at least 25 and an HbA1c between 7.5% and 10.5%. Participants must be taking metformin (with or without an SGLT-2 inhibitor) at a stable dose for at least 3 months before joining.

Inclusion Criteria

Body mass index (BMI) ≥ 25 kg/m² at screening
I have type 2 diabetes and have been on a stable dose of metformin for at least 90 days.
HbA1c of ≥ 7.5% (58.0 mmol/mol) and ≤ 10.5% (91.0 mmol/mol) at screening

Exclusion Criteria

Self-reported change in body weight > 5% within 90 days before screening and agreement not to initiate intensive diet or exercise program during the trial except lifestyle/dietary measures for diabetes treatment
I am being treated or plan to be treated for diabetic eye disease or macular swelling.
I have been diagnosed with serious diabetic eye disease.
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Maridebart Cafraglutide
  • Semaglutide

Trial Overview

The study compares two injectable medications, maridebart cafraglutide and semaglutide, to see if the new drug works as well as semaglutide in controlling blood sugar in people with type 2 diabetes already on metformin.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Maridebart cafraglutideExperimental Treatment1 Intervention
Group II: SemaglutideActive Control1 Intervention

Find a Clinic Near You

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 profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

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

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