What side effects are associated with this type of intervention?

Common treatments for obesity, particularly those similar to CagriSema (a combination of Cagrilintide and Semaglutide), often involve GLP-1 receptor agonists like Semaglutide. These treatments can cause gastrointestinal side effects such as nausea, vomiting, diarrhea, and constipation. Other possible side effects include headache, dizziness, and an increased heart rate. Rare but serious side effects may include pancreatitis and gallbladder disease. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity, which are similar to the Semaglutide component of CagriSema. Notably, Liraglutide (Saxenda) was approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition. Semaglutide (Wegovy) was also approved for weight management in adults with obesity or overweight with related comorbidities. These treatments have shown efficacy in weight loss and are administered via subcutaneous injection, similar to the investigational combination of Cagrilintide and Semaglutide in CagriSema.

What other types of research exist?

Promising novel alternatives to CagriSema for obesity treatment in 2024 include Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown significant weight loss in clinical trials. Additionally, combination therapies such as phentermine-topiramate and newer GLP-1 receptor agonists like Liraglutide and Semaglutide (in higher doses) are also potential options.

← Back to Search

Amylin Analog

CagriSema vs. Tirzepatide for Weight Loss in Obesity

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

Be older than 18 years old

Must not have

History of type 1 or type 2 diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to end of study (week 78)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if a new combination of two drugs, given regularly, helps people lose weight better than another treatment. It targets individuals needing to lower their body weight by helping them feel less hungry and manage their weight. Two different drugs are being investigated as options for weight management.

Who is the study for?

This trial is for adults with obesity, defined as having a BMI of 30 or higher. It's not suitable for people who have diabetes (type 1 or type 2) or those with an HbA1c level of 6.5% or more, which indicates high blood sugar levels.

What is being tested?

The study compares the effectiveness of CagriSema—a combination of two drugs, Cagrilintide and Semaglutide—with Tirzepatide in helping individuals lose weight. Participants will self-administer weekly injections using a pen injector over approximately one and a half years.

What are the potential side effects?

Potential side effects may include digestive issues like nausea and diarrhea, injection site reactions such as redness or pain, increased heart rate, and possibly low blood sugar levels.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of study (week 78)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to end of study (week 78)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 78) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Relative change in body weight

Secondary study objectives

Achievement of greater than or equal to (≥) 25% weight reduction

Achievement of ≥ 30% weight reduction

Change in diastolic blood pressure (DBP)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CagriSema 2.4 mg/2.4 mgExperimental Treatment2 Interventions

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.

Group II: Tirzepatide 15 mgActive Control1 Intervention

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

0 / 1Eligibility criteria met

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 GLP-1 receptor agonists (e.g., Semaglutide) and dual agonists (e.g., Tirzepatide), work by mimicking hormones that regulate appetite and glucose metabolism. GLP-1 receptor agonists increase insulin secretion, slow gastric emptying, and promote a feeling of fullness, leading to reduced food intake. Dual agonists like Tirzepatide also target GIP receptors, enhancing these effects. These mechanisms are important for obesity patients as they help achieve significant weight loss, improve glycemic control, and reduce the risk of obesity-related complications.