Recruiting
Phase 3

Maridebart & Semaglutide

Sponsor:

Amgen

Code:

NCT07866066

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Maridebart cafraglutide

Semaglutide

Study Details

Brief 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

Diabetes Mellitus, Type 2

Study ID

NCT07866066

Start date

Oct 16, 2026

Status verified date

Oct, 2026

Completion date

Dec 5, 2028

Anticipated

Primary completion date

Sep 6, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maridebart cafraglutide

Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner.

active comparator: Semaglutide

Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner.

Interventions

Maridebart cafraglutide

Administered subcutaneously.

Semaglutide

Administered subcutaneously.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Acclaim Clinical Research

Recruiting

San Diego, California, United States, 92120

Bioclinical Research Alliance

Recruiting

Miami, Florida, United States, 33155

Indago Research and Health Center

Recruiting

Miami Lakes, Florida, United States, 33016

Clinical Research Center Of Florida

Recruiting

Pompano Beach, Florida, United States, 33060

Conquest Research - Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Virginia Nephrology Group

Recruiting

Arlington, Virginia, United States, 22205

Eastside Research Associates Health Research

Recruiting

Redmond, Washington, United States, 98052

Dr T G Elliott Incorporated - BC Diabetes

Recruiting

Vancouver, British Columbia, Canada, V5Y 3W2

More Information

Sponsor

Amgen

Last update posted

Nov 5, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Amgen on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.