A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

Novo Nordisk

Status and phase: Active, not recruiting; Phase 3

Conditions: Obesity

Treatments: Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I); Drug: CagriSema (Cagrilintide B and Semaglutide I)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07011667

NN9838-8484

U1111-1318-6372 (Other Identifier)

Details and patient eligibility

About

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.

Enrollment: 609 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

key Inclusion Criteria:

• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.
• BMI ≥ 30.0 kilogram per square meter (kg/m^2) at screening.
• Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.

key Exclusion Criteria:

• Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole 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

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609 participants in 2 patient groups, including a placebo group

CagriSema

Experimental group

Description:

Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive 1 of the 3 dose levels of CagriSema for 80 weeks.

Treatment:

Drug: CagriSema (Cagrilintide B and Semaglutide I)

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks.

Treatment:

Drug: CagriSema (Cagrilintide B and Semaglutide I)

Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)