A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Novo Nordisk

Status and phase: Active, not recruiting; Phase 3

Conditions: Obesity

Treatments: Drug: Cagrilintide; Drug: Tirzepatide; Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06131437

U1111-1292-4835 (Other Identifier)

NN9838-7832

Details and patient eligibility

About

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Age 18 years or above at the time of signing the informed consent
• Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2)

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 mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

CagriSema 2.4 mg/2.4 mg

Experimental group

Description:

Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 72 weeks.

Treatment:

Drug: Semaglutide

Drug: Cagrilintide

Tirzepatide 15 mg

Active Comparator group

Description:

Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 72 weeks.

Treatment:

Drug: Tirzepatide