No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,300 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
This trial is looking for people with type 2 diabetes who are currently taking metformin. Participants will take either maridebart cafraglutide or semaglutide to see which one helps control blood sugar better.
Are You a Good Fit for This Trial?
Must be takingMetformin
Rules you outType 1 diabetesDiabetic retinopathy
You may be able to join if
I have type 2 diabetes.
I take at least 1500 mg of metformin daily.
I have an HbA1c between 7.5% and 10.5%.
I am at least 25 kg/m² in body mass index.
You may not be able to join if
I have type 1 diabetes.
I have had severe low blood sugar in the last 6 months.
I have been diagnosed with diabetic eye disease.
I have changed my weight by more than 5% recently.
I am planning to have weight loss surgery during the trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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 co…
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.
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