A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

Novo Nordisk

Status and phase: Active, not recruiting; Phase 3

Conditions: Obesity

Treatments: Drug: Semaglutide; Drug: Cagrilintide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06388187

2023-509273-24 (Other Identifier)

U1111-1298-3451 (Other Identifier)

NN9838-7749

Details and patient eligibility

About

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female

• Age above or equal to 18 years at the time of signing informed consent

  1. Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m^2) or
  2. BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion criteria

• Glycated haemoglobin (HbA1c) ≥6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening
• History of type 1 or type 2 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

300 participants in 4 patient groups, including a placebo group

CagriSema Dose 1

Experimental group

Description:

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks.

Treatment:

Drug: Cagrilintide

Drug: Semaglutide

Placebo Dose 1

Placebo Comparator group

Description:

Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.

Treatment:

Drug: Placebo

CagriSema Dose 2

Active Comparator group

Description:

Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.

Treatment:

Drug: Cagrilintide

Drug: Semaglutide

Placebo Dose 2

Placebo Comparator group

Description:

Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.

Treatment:

Drug: Placebo