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

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

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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