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

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Novo Nordisk

Status and phase

Not yet enrolling
Phase 1

Conditions

Overweight
Obesity

Treatments

Drug: Placebo
Drug: Cagrilintide and Semaglutide
Other: No treatment given

Study type

Interventional

Funder types

Industry

Identifiers

NCT06267092
NN9838-4944

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female
  • Aged 18-65 years (both inclusive) at the time of signing informed consent
  • Right-handed as evaluated by the Edinburgh Handedness Inventory
  • Body weight less than or equal to 180 kilogram at screening

For Part A:

  • A score of 7 or less on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
  • Body mass index between 18.5 and 24.9 kilogram per meter square (both inclusive) at screening

For Part B:

  • A score of 8 or more on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
  • Body mass index equal to or above 27.0 kilogram per meter square. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion criteria

Contraindication for magnetic resonance scanning

For Part B:

  • Glycated haemoglobin greater than or equal to 6.5 % (48 millimoles per mole) at screening
  • History of type 1 or type 2 diabetes mellitus

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups

Part A
Other group
Description:
Participants will not get any medicine during this study.
Treatment:
Other: No treatment given
Part B
Experimental group
Description:
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.
Treatment:
Drug: Cagrilintide and Semaglutide
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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