What is the mechanism of action of this treatment?

Common treatments for obesity, such as the combination of cagrilintide and semaglutide in CagriSema, work by mimicking hormones that regulate appetite and glucose metabolism. Cagrilintide is an amylin analog that slows gastric emptying and promotes satiety, reducing food intake. Semaglutide is a GLP-1 receptor agonist that enhances insulin secretion, inhibits glucagon release, and also promotes satiety. These mechanisms help patients lose weight by reducing hunger and improving blood sugar control, which is crucial for managing obesity and its related health conditions.

What side effects are associated with this type of intervention?

Common treatments for obesity that involve GLP-1 receptor agonists, such as semaglutide, and other appetite-regulating hormones like cagrilintide, often have side effects including nausea, vomiting, diarrhea, and constipation. These gastrointestinal issues are the most frequently reported. Other potential side effects can include headache, fatigue, and dizziness. In some cases, there may be an increased risk of pancreatitis and gallbladder disease. It's important for patients to discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity that function similarly to CagriSema by mimicking hormones that regulate appetite and glucose metabolism. Notable examples include semaglutide (marketed as Wegovy for weight management), which is a GLP-1 receptor agonist, and liraglutide (marketed as Saxenda), another GLP-1 receptor agonist. These medications help reduce appetite and improve glycemic control, aiding in weight loss. Other approved treatments include phentermine-topiramate (Qsymia) and naltrexone-bupropion (Contrave), which also target appetite regulation and metabolic processes.

What other types of research exist?

Promising alternatives to CagriSema for obesity treatment include: 1) GLP-1 receptor agonists like liraglutide and dulaglutide, which help regulate appetite and glucose metabolism. 2) Ghrelin receptor antagonists, which block hunger signals and are under intensive investigation. 3) Combination therapies such as phentermine-topiramate, which have shown significant weight loss in clinical trials. 4) Anamorelin, a ghrelin mimetic, which is being evaluated for its potential to manage weight loss in various conditions.

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Amylin analog

CagriSema for Obesity (REDEFINE 1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to end of study-main part (week 75)

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects aren't specified here but typically may include reactions at the injection site, gastrointestinal symptoms like nausea or diarrhea, headaches, fatigue, and potential changes in appetite.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of study-main part (week 75)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to end of study-main part (week 75)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study-main part (week 75) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction

Secondary study objectives

CagriSema 0.5 mg/0.5 mg versus placebo: Relative change in body weight

CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg; and CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight

CagriSema 2.4 mg/2.4 mg versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score

+62 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cagrilintide

2023

Completed Phase 1

~150

Semaglutide

2021

Completed Phase 4

~5160

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as the combination of cagrilintide and semaglutide in CagriSema, work by mimicking hormones that regulate appetite and glucose metabolism. Cagrilintide is an amylin analog that slows gastric emptying and promotes satiety, reducing food intake. Semaglutide is a GLP-1 receptor agonist that enhances insulin secretion, inhibits glucagon release, and also promotes satiety. These mechanisms help patients lose weight by reducing hunger and improving blood sugar control, which is crucial for managing obesity and its related health conditions.