CagriSema for Obesity (REDEFINE 1 Trial)

Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests how well different treatments help people with excess body weight lose weight. Participants will receive one of four treatments through regular injections. The study will last over a year, followed by a period to observe long-term effects.

Eligibility Criteria

Adults with a BMI of at least 30, or at least 27 with weight-related health issues like high blood pressure or sleep apnea can join. It's not for those who have diabetes or an HbA1c level of 6.5% or higher.

Treatment Details

The trial is testing CagriSema against placebo and two other drugs, cagrilintide and semaglutide, to see which helps more with weight loss. Participants get one injection weekly by chance and are monitored for about 1.5 years, followed by a 2-year extension study without medication.

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Cagrisema s.c. 2.4 mg/2.4 mgExperimental Treatment2 Interventions

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.

Group II: Semaglutide s.c. 2.4 mgActive Control2 Interventions

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.

Group III: Cagrilintide s.c. 2.4 mgActive Control2 Interventions

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.

Group IV: Placebo s.c.Placebo Group2 Interventions

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.