NCT07866066Not yet recruitingPhase 3
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1300 (estimated)
- First submitted
- 5 Oct 2026
- Start date
- 2 Nov 2026
- Primary completion date
- 4 Sept 2028
- Lead sponsor
- Amgen
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07866066
- EU CT number
- 2025-523772-22-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1300
- From 2 Nov 2026 to the primary completion date, 4 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
- 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.
- 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.
Other illness
- 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.
- History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
Other
- Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.