Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes

NCT07866066
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Not yet recruiting
clinicaltrials.gov
Participants
1,300
clinicaltrials.gov
Lead sponsor
Amgen
clinicaltrials.gov
Start date
2026-11-02
clinicaltrials.gov

Summary
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
Acronym
MARITIME-T2D-3
clinicaltrials.gov
Short title
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
clinicaltrials.gov
Official title
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
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Not yet recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-12-04
clinicaltrials.gov
First posted
2026-10-08
clinicaltrials.gov
Registry last updated
2026-10-08
clinicaltrials.gov
Primary completion date
2028-09-04
clinicaltrials.gov
Start date
2026-11-02
clinicaltrials.gov

Participants
1,300
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
1,300
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Amgen
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07866066
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07866066
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: Baseline to Week 68

  1. Change from Baseline in HbA1c at week 68 [Superiority]

    Timeframe: Baseline to Week 68

  2. Percent Change from Baseline in Body Weight at Week 68

    Timeframe: Baseline to Week 68

  3. Percentage of Participants Achieving HbA1c < 7.0% at Week 68

    Timeframe: Week 68

  4. Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68

    Timeframe: Week 68

  5. Percentage of Participants Achieving HbA1c < 5.7% at Week 68

    Timeframe: Week 68

  6. Change from Baseline in Fasting Plasma Glucose at Week 68

    Timeframe: Baseline to Week 68

  7. Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68

    Timeframe: Baseline to Week 68

  8. Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68

    Timeframe: Baseline to Week 68

  9. Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68

    Timeframe: Baseline to Week 68

  10. Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68

    Timeframe: Baseline to Week 68

  11. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Timeframe: Up To 81 Weeks

  12. Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes

    Timeframe: Up To 81 Weeks

  13. Plasma Concentration of Maridebart Cafraglutide at Week 68

    Timeframe: Week 68

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • 2025
  • 2025-523772-22-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (2)