2500 Participants NeededMy employer runs this trial

CagriSema + Semaglutide for Obesity

Recruiting at 304 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CagriSema to evaluate its effectiveness in helping people with obesity, with or without type 2 diabetes, lose weight. Participants will receive either CagriSema or semaglutide, a drug already used for weight management, to compare their effects. The main goal is to assess the safety and effectiveness of CagriSema for weight loss over approximately 83 weeks. This trial may suit individuals with a BMI of 35 or higher who have not recently used certain weight-loss medications. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the development of a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that you have not used any medications with GLP-1 RA activity or amylin analogues in the 6 months before screening. If you are taking these types of medications, you would need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CagriSema is generally safe, with side effects similar to other common treatments. Some studies found that it can lead to significant weight loss and causes less vomiting compared to other options. Semaglutide, already a prescribed medication, has a strong safety record. It has proven effective in aiding weight loss and is considered safe in clinical trials.

Both treatments are usually well-tolerated, but like any medicine, they can have side effects. Prospective participants should know that both treatments have demonstrated promising safety results in studies.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments, CagriSema and Semaglutide, because they offer innovative approaches to tackling obesity. Unlike standard treatments like lifestyle changes and medications such as orlistat, Semaglutide has already gained attention for its ability to effectively manage weight by mimicking a hormone that controls appetite. CagriSema is especially intriguing because it combines Semaglutide with another component, potentially enhancing its effectiveness. This combination might offer more significant weight loss than current options, providing a promising new avenue for individuals struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare the effects of CagriSema and Semaglutide for obesity. Studies have shown that CagriSema can lead to significant weight loss. In one study, participants lost up to 22.7% of their body weight with this treatment, while those with type 2 diabetes lost about 15.7%. Semaglutide, a medication already available for prescription, also demonstrates strong results, with an average weight loss of 14.9%. Both treatments show promise in helping individuals with obesity, regardless of type 2 diabetes status, to lose weight. Participants in this trial will receive either CagriSema at different dose levels or Semaglutide to evaluate their effectiveness.23678

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older with obesity (BMI of 35 or higher), with or without type 2 diabetes. People can't join if they've recently lost more than 5% body weight in the last 3 months, or have used certain weight loss medications in the past 6 months.

Inclusion Criteria

I am 18 years old or older.
My sex assigned at birth is male or female.
BMI≥ 35.0 kg/m^2
See 1 more

Exclusion Criteria

A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records
I have not used GLP-1 or amylin medications in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CagriSema or Semaglutide once weekly subcutaneously for weight loss

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CagriSema
  • Semaglutide

Trial Overview

The study compares two different doses of a new medicine called CagriSema to one dose of semaglutide (an approved drug) to see which helps people lose more weight. Participants are randomly assigned to one group and will be treated for about 83 weeks.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Cagrisema - dose level 1Experimental Treatment1 Intervention
Group II: Cagrisema - dose level 2Active Control1 Intervention
Group III: SemaglutideActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

CagriSema Reduces Blood Pressure in Adults With ... - PMC

The REDEFINE 1 trial demonstrated that once-weekly subcutaneous cagrilintide/semaglutide (CagriSema) 2.4 mg/2.4 mg for 68 weeks resulted in weight loss of 22.7% ...

CagriSema Demonstrates Significant Weight Loss in Adults ...

Once-weekly medication results in weight loss of up to 22.7% in adults without diabetes and 15.7% in those with type 2 diabetes.

CagriSema demonstrated superior HbA1c reduction of 1.91%

CagriSema achieved superior weight loss of up to 14.2%, where up to 43% of the people achieved ≥15% weight loss and up to 24% achieved ≥20% ...

Coadministered Cagrilintide and Semaglutide in Adults ...

The estimated mean percent change in body weight from baseline to week 68 was –20.4% with cagrilintide–semaglutide as compared with –3.0% with ...

Efficacy and Safety of Cagrilintide and Cagrisema Versus ...

Overall, cagrisema showed consistently greater reductions in body weight, BMI, and fasting plasma glucose, while cagrilintide appeared non- ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41834765/

Efficacy and Safety of Cagrilintide and Cagrisema Versus ...

Cagrisema is safe and has a comparable side effect profile to currently accepted treatments. This regimen has enormous potential in dual-agonist ...

Efficacy and Safety of Cagrilintide Alone and in Combination ...

Cagrisema outperforms semaglutide regarding weight loss. Cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.

CagriSema Elicits Significant Weight Loss in Obesity With ...

Participants with full treatment adherence lost a mean 22.7% of their body weight with CagriSema, and 40.4% of these participants experienced at ...