A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1)

Novo Nordisk

Status and phase: Active, not recruiting; Phase 3

Conditions: Obesity

Treatments: Drug: Placebo cagrilintide; Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05567796

2020-005435-75 (EudraCT Number)

Universal Trial Number (UTN) (Registry Identifier)

NN9838-4608

Details and patient eligibility

About

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms.

Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

Enrollment: 3,400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Age above or equal to 18 years at the time of signing informed consent
• Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion criteria

• Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b) 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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3,400 participants in 4 patient groups, including a placebo group

Cagrisema s.c. 2.4 mg/2.4 mg

Experimental group

Description:

Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.

Treatment:

Drug: Semaglutide

Drug: Cagrilintide

Cagrilintide s.c. 2.4 mg

Active Comparator group

Description:

Participants will receive cagrilintide s.c. 2.4 mg and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.

Treatment:

Drug: Placebo semaglutide

Drug: Cagrilintide

Semaglutide s.c. 2.4 mg

Active Comparator group

Description:

Participants will receive semaglutide s.c. 2.4 mg and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.

Treatment:

Drug: Semaglutide

Drug: Placebo cagrilintide

Placebo s.c.

Placebo Comparator group

Description:

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.

Treatment:

Drug: Placebo semaglutide

Drug: Placebo cagrilintide