Diabetes Mellitus, Type 2Phase 3MARITIME-T2D-3NCT07866066
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
A Phase 3 study testing Maridebart cafraglutide and Semaglutide in people with Diabetes Mellitus, Type 2, run by Amgen at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Maridebart cafraglutide and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 16 Oct 2026to 5 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Virginia Nephrology Group
Arlington, Virginia, 22205
- Recruiting
Bioclinical Research Alliance
Miami, Florida, 33155
- Recruiting
Indago Research and Health Center
Miami Lakes, Florida, 33016
- Recruiting
Clinical Research Center Of Florida
Pompano Beach, Florida, 33060
- Recruiting
Eastside Research Associates Health Research
Redmond, Washington, 98052
- Recruiting
Acclaim Clinical Research
San Diego, California, 92120
- Recruiting
Conquest Research - Winter Park
Winter Park, Florida, 32789
Canada1 site, 1 recruiting
- Recruiting
Dr T G Elliott Incorporated - BC Diabetes
Vancouver, British Columbia, V5Y 3W2
About this study
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
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
- Diabetes Mellitus, Type 2
- Being tested
- Maridebart cafraglutide, Semaglutide
- Keywords
- Add-on to Metformin, Maridebart Cafraglutide, Semaglutide, MariTide, A1C, Weight, Obesity, Overweight
- Medical subject headings
- Diabetes Mellitus, Type 2, Body Weight, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maridebart cafraglutideDrug
Also called AMG 133, MariTide
Administered subcutaneously.
SemaglutideDrug
Administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Maridebart cafraglutide | Experimental | Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. Receives: Drug: Maridebart cafraglutide |
| Semaglutide | Active comparator | Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Measured: Baseline to Week 68
Secondary outcomes (13)
Change from Baseline in HbA1c at week 68 [Superiority]
Measured: Baseline to Week 68
Percent Change from Baseline in Body Weight at Week 68
Measured: Baseline to Week 68
Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Measured: Week 68
Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
Measured: Week 68
Percentage of Participants Achieving HbA1c < 5.7% at Week 68
Measured: Week 68
Change from Baseline in Fasting Plasma Glucose at Week 68
Measured: Baseline to Week 68
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
Measured: Baseline to Week 68
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
Measured: Baseline to Week 68
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
Measured: Baseline to Week 68
Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
Measured: Baseline to Week 68
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up To 81 Weeks
Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
Measured: Up To 81 Weeks
Plasma Concentration of Maridebart Cafraglutide at Week 68
Measured: Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start16 Oct 2026
- Primary completion6 Sep 2028 (estimated)
- Study completion5 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866066
- Sponsor's protocol ID
- 20230220
- Other IDs
- 2025-523772-22-00, 2025
- Acronym
- MARITIME-T2D-3
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ID
- NCT07866066
- Acronym / sponsor ID
- MARITIME-T2D-3 / 20230220
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Add-on to Metformin, Maridebart Cafraglutide, Semaglutide, MariTide, A1C, Weight, Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- 6 Sep 2028 (estimated)
- Study completion
- 5 Dec 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maridebart cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. |
| Semaglutide | Active comparator | Drug: SemaglutideParticipants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maridebart cafraglutideAlso: AMG 133, MariTideAdministered subcutaneously. | Drug | Maridebart cafraglutide |
| SemaglutideAdministered subcutaneously. | Drug | Semaglutide |
Primary outcome
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Time frame: Baseline to Week 68
13 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maridebart cafraglutide and Semaglutide in people with Diabetes Mellitus, Type 2, run by Amgen at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority] (time frame: Baseline to Week 68). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.