Recruiting
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
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.
ClinicalTrials.gov IDNCT07866066
PhasePHASE3
Enrollment1300
SponsorAmgen
Age18 Years and older
SexALL
Conditions studied
Diabetes Mellitus, Type 2
About this study
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.
Interventions
- Drug: Maridebart cafraglutide — Administered subcutaneously.
- Drug: Semaglutide — Administered subcutaneously.
Primary outcomes
- Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority] (Baseline to Week 68)
Eligibility information
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.
Study locations
- Acclaim Clinical Research, San Diego, California 92120 United States
- Bioclinical Research Alliance, Miami, Florida 33155 United States
- Indago Research and Health Center, Miami Lakes, Florida 33016 United States
- Clinical Research Center Of Florida, Pompano Beach, Florida 33060 United States
- Conquest Research - Winter Park, Winter Park, Florida 32789 United States
- Virginia Nephrology Group, Arlington, Virginia 22205 United States
- Eastside Research Associates Health Research, Redmond, Washington 98052 United States
- Dr T G Elliott Incorporated - BC Diabetes, Vancouver, British Columbia V5Y 3W2 Canada
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-09.