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Recruiting Phase 3

Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes

NCT07866066 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 3
Started
2026-10-16
Last updated
2026-11-05

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Maridebart cafraglutide →Semaglutide →

Maridebart cafraglutide: Administered subcutaneously.

Semaglutide: Administered subcutaneously.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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: * 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.

Primary outcome measure(s)

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

Trial sites (8)

FacilityCityRegionStatus
Acclaim Clinical Research San Diego California Recruiting
Bioclinical Research Alliance Miami Florida Recruiting
Indago Research and Health Center Miami Lakes Florida Recruiting
Clinical Research Center Of Florida Pompano Beach Florida Recruiting
Conquest Research - Winter Park Winter Park Florida Recruiting
Virginia Nephrology Group Arlington Virginia Recruiting
Eastside Research Associates Health Research Redmond Washington Recruiting
Dr T G Elliott Incorporated - BC Diabetes Vancouver British Columbia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07866066 on ClinicalTrials.gov ↗ ← All trials in the USA