A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Semaglutide; Drug: Cagrilintide; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06221969

U1111-1282-5561 (Other Identifier)

2023-503789-21-00 (Other Identifier)

NN9388-4894

Details and patient eligibility

About

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female.
• Age 18 years or above at the time of signing the informed consent.
• Diagnosed with type 2 diabetes ≥ 180 days before screening.
• Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
• HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
• Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
• Renal impairment with estimated Glomerular Filtration Rate < 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening.
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

CagriSema

Experimental group

Description:

Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.

Treatment:

Drug: Cagrilintide

Drug: Semaglutide

Tirzepatide

Active Comparator group

Description:

Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.

Treatment:

Drug: Tirzepatide