Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Semaglutide 2.4 mg; Drug: Cagrilintide 2.4 mg; Drug: Placebo (semaglutide); Drug: Placebo (cagrilintide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04982575

NN9838-4862

Details and patient eligibility

About

This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone.

Before a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective.

Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance.

A dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected.

Participants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how.

The study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor.

At 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed).

Women who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female of non-childbearing potential or male
• Age above or equal to 18 years at the time of signing informed consent
• Body mass index (BMI) greater than or equal to 27.0 kg/m^2
• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
• Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening
• Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor

Exclusion criteria

• 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 days and prior insulin treatment for gestational diabetes are allowed
• Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m^2 by 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 3 patient groups

Cagrilintide 2.4 mg and semaglutide 2.4 mg

Experimental group

Description:

Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.

Treatment:

Drug: Cagrilintide 2.4 mg

Drug: Semaglutide 2.4 mg

Cagrilintide 2.4 mg and placebo (semaglutide)

Active Comparator group

Description:

Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks

Treatment:

Drug: Placebo (semaglutide)

Drug: Cagrilintide 2.4 mg

Semaglutide 2.4 mg and Placebo (cagrilintide)

Active Comparator group

Description:

Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks

Treatment:

Drug: Placebo (cagrilintide)

Drug: Semaglutide 2.4 mg