Maridebart cafraglutide vs. semaglutide for type 2 diabetes on metformin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, non-inferiority study comparing maridebart cafraglutlutide to semaglutide in adults with type 2 diabetes who are on metformin, with or without an SGLT-2 inhibitor. Participants must have an HbA1c between 7.5% and 10.5% and a BMI of at least 25 kg/m^2. The trial is conducted at multiple sites in the United States and is sponsored by Amgen. Primary outcomes focus on glycemic control; secondary considerations include safety and tolerability. Enrollment targets adults with prior metformin therapy and stable background therapy, excluding those with certain retinopathy conditions or a history of type 1 diabetes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
* Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.
* Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m\^2) at screening.

Exclusion Criteria:

* Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.
* Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
* Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
* One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
* History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
* Self-reported change in body weight \> 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
* Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:

  * liposuction and/or abdominoplasty that was performed \> 1 year before screening.
  * laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed \> 1 year before screening.

Where it's running

• Acclaim Clinical Research
  San Diego, California, United States Recruiting
• Bioclinical Research Alliance
  Miami, Florida, United States Recruiting
• Indago Research and Health Center
  Miami Lakes, Florida, United States Recruiting
• Clinical Research Center Of Florida
  Pompano Beach, Florida, United States Recruiting
• Conquest Research - Winter Park
  Winter Park, Florida, United States Recruiting
• Virginia Nephrology Group
  Arlington, Virginia, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.