Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

NN9838-4609

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

2023-02-01

2024-12-11

2025-01-29

Active (not recruiting)

Early phase I

1200

Inclusion Criteria: * Male or female * Age above or equal to 18 years at the time of signing informed consent * BMI greather than or equal to 27.0 kg/m\^2 * Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening * Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label * Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening * HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening Exclusion Criteria: * Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness * Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1200, 'type': 'ACTUAL'}}

2024-04-22