A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight

Sponsor
Novo Nordisk A/S
Study ID
NCT06207877
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cagrilintide — DRUG
    Cagrilintide will be administered subcutaneously.
  • Semaglutide — DRUG
    Semaglutide will be administered subcutaneously.
  • Placebo — DRUG
    Placebo will be administered subcutaneously.

Study Details

This research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. The study will last for about 32 weeks.

Key Dates

Start date
Feb 23, 2024
Status verified
Jan 2026
Primary completion
Oct 16, 2024
Completion
Nov 22, 2024

Study Design

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

Arms

  • Experimental: CagriSema
    Participants will receive dose 1 cagrilintide and dose 2 semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) during the maintenance period of 5 weeks.
  • Active Comparator: Placebo
    Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks.

Primary Outcome Measure

Relative change in energy intake during ad libitum lunch, evening meal and snackbox [ Time Frame: Baseline to Day 156 ]

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