Not yet recruitingNCT07866066MARITIME-T2D-3Updated Oct 8, 2026

Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes

A Phase 3 interventional study of Maridebart cafraglutide and Semaglutide in Diabetes Mellitus, Type 2, sponsored by Amgen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓

Phase: Phase 3
Study type: Interventional
Enrollment: 1,300
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Diabetes Mellitus, Type 2

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Keywords

Add-on to Metformin
Maridebart Cafraglutide
Semaglutide
MariTide
A1C
Weight
Obesity
Overweight

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Amgen is the lead sponsor of 1,016 studies on the registry; 50 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,300 participants (estimated)

Study arms

Experimental
Maridebart cafraglutide
Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner.
Drug: Maridebart cafraglutide
Active comparator
Semaglutide
Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner.
Drug: Semaglutide

Interventions

DrugMaridebart cafraglutide
Administered subcutaneously.
Also known as: AMG 133, MariTide
DrugSemaglutide
Administered subcutaneously.

What researchers measure

Primary outcomes

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

Secondary outcomes

Change from Baseline in HbA1c at week 68 [Superiority]
Time frame: Baseline to Week 68
Percent Change from Baseline in Body Weight at Week 68
Time frame: Baseline to Week 68
Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Time frame: Week 68
Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
Time frame: Week 68
Percentage of Participants Achieving HbA1c < 5.7% at Week 68
Time frame: Week 68
Change from Baseline in Fasting Plasma Glucose at Week 68
Time frame: Baseline to Week 68
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
Time frame: Baseline to Week 68
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
Time frame: Baseline to Week 68
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
Time frame: Baseline to Week 68
Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
Time frame: Baseline to Week 68
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up To 81 Weeks
Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
Time frame: Up To 81 Weeks
Plasma Concentration of Maridebart Cafraglutide at Week 68
Time frame: Week 68

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Csr

Updates

1 registry update since Sep 25, 2026

Registered

First appeared on the registry. No changes since

Oct 8, 2026

Show all 1 update

Oct 8, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07866066
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Oct 8, 2026
Start date: Nov 2, 2026 (estimated)
Primary completion: Sep 4, 2028 (estimated)
Completion: Dec 4, 2028 (estimated)
Last update: Oct 8, 2026

Study contacts

Amgen Call Center

Contact

medinfo@amgen.com

866-572-6436

study director · Amgen

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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