Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT06403761
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Participants will receive once-weekly semaglutide subcutaneously.
  • Cagrilintide — DRUG
    Participants will receive once-weekly cagrilintide subcutaneously.
  • Placebo semaglutide — DRUG
    Participants will receive once-weekly placebo matched to semaglutide subcutaneously.
  • Placebo cagrilintide — DRUG
    Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Study Details

This study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D). CagriSema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. Doctors may not yet prescribe CagriSema. Participants will either get CagriSema, semaglutide, cagrilintide, or a ''dummy'' medicine. Which treatment the participants will get is decided by chance. Participants will get the study medicine together with the current daily diabetes medicine metformin. Participants should not take other medicines for diabetes during the study. The study will last for about 42 weeks.

Key Dates

Start date
May 6, 2024
Status verified
Feb 2026
Primary completion
Dec 28, 2025
Completion
Feb 2, 2026

Study Design

Enrollment
158 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CagriSema
    Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks.
  • Experimental: Semaglutide
    Participants will receive once-weekly s.c injections of semaglutide at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks.
  • Experimental: Cagrilintide
    Participants will receive once-weekly s.c injections of cagrilintide at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks.
  • Placebo Comparator: Placebo
    Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 28 weeks.

Primary Outcome Measure

To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC) [ Time Frame: Baseline to week 28 ]

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