Health TrialsbyHealthPanel

Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes

ConditionDiabetes Mellitus, Type 2
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmgen

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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/m²) at screening.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maridebart cafraglutide

    Drug

    Administered subcutaneously.

  • Semaglutide

    Drug

    Administered subcutaneously.

Treatment groups

1,300 Participants
are divided into 2 treatment groups
Group A: Maridebart cafraglutideExperimental treatment 1 intervention
Group B: SemaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]

Time frame
Baseline to Week 68

Secondary outcomes

1

Change from Baseline in HbA1c at week 68 [Superiority]

Time frame
Baseline to Week 68
2

Percent Change from Baseline in Body Weight at Week 68

Time frame
Baseline to Week 68
3

Percentage of Participants Achieving HbA1c < 7.0% at Week 68

Time frame
Week 68
4

Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68

Time frame
Week 68

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: