Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: CagriSema

Study type: Interventional

Funder types: Industry

Identifiers

NCT07817251

NN9388-8593

U1111-1332-8482 (Other Identifier)

Details and patient eligibility

About

The purpose of this clinical study is to look at the safety and tolerability of switching from semaglutide to CagriSema, for participants who have type 2 diabetes. All participants will get CagriSema, the treatment being tested. Participants will be in this clinical study for about 6 months.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18 years or above at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening.
• Stable once-weekly dose ≥ 90 days before screening of branded s.c. semaglutide. Branded semaglutide s.c. includes Ozempic and Wegovy. Participants on compounded semaglutide are ineligible.
• Not on treatment with oral antidiabetic drugs or on stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen at effective or maximum tolerated dose (MTD) as judged by the investigator: metformin and/or sodiumglucose co-transporter-2 (SGLT2) inhibitor.
• Glycated haemoglobin (HbA1c) 6.5-10.5 percentage (%) (48-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
• Body mass index (BMI) ≥ 25 kilograms 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 from screening.
• Renal impairment with estimated glomerular filtration rate (eGFR) less than (<) 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 an eye 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.
• A self-reported change in body weight > 5% within 90 days before screening irrespective of medical records.
• Use of personal continuous glucose monitoring (CGM) devices. Participants currently using personal CGM devices must discontinue use prior to screening and throughout study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups

CagriSema dose 1

Experimental group

Description:

Participants previously treated with once-weekly semaglutide subcutaneously (s.c.) will switch to once-weekly CagriSema dose 1.

Treatment:

Drug: CagriSema

CagriSema dose 2

Experimental group

Description:

Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 2, followed by dose 1.

Treatment:

Drug: CagriSema

CagriSema dose 3

Experimental group

Description:

Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 3, followed by dose 2 and dose 1.

Treatment:

Drug: CagriSema