Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Semaglutide 2.4 mg; Cagrilintide 2.4 mg; Placebo (semaglutide); Placebo (cagrilintide)
Intervention description: Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks; Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks; Placebo (semaglutide) administered s.c. (subcutaneously, under the skin) once weekly.
Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks; Placebo (cagrilintide) administered s.c. (subcutaneously, under the skin) once weekly.
Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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
    

Eligibility criteria:

        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