A Study of How CagriSema Works on Appetite in People With Excess Body Weight

Sponsor
Novo Nordisk A/S
Study ID
NCT06267092
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • No treatment given — OTHER
    Participants will not get any medicine during this study.
  • Cagrilintide and Semaglutide — DRUG
    Participants will receive subcutaneous (s.c.) injections of Cagrilintide and Semaglutide.
  • Placebo — DRUG
    Participants will receive subcutaneous (s.c.) injections of placebo matched to Cagrilintide and Semaglutide.

Study Details

Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months. Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine.

Key Dates

Start date
Feb 15, 2024
Status verified
Jan 2026
Primary completion
Apr 7, 2025
Completion
Dec 8, 2025

Study Design

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

Arms

  • Other: Part A
    Participants will not get any medicine during this study.
  • Experimental: Part B
    Participants will receive CagriSema or placebo (Dose 1,2,3,4) for 16-weeks dose-escalation period followed by 37-weeks intervention period on CagriSema or placebo (Dose 5) that includes a 12-day standardised energy intake period.

Primary Outcome Measure

Change in mean postprandial appetite score based on visual analogue scale (VAS) [ Time Frame: Baseline to week 24 ]

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