CagriSema for Obesity

Not yet recruiting at 95 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
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 aims to determine how well a medicine called CagriSema aids weight loss in individuals with overweight or obesity. Participants will receive injections of either two different versions of CagriSema or a placebo (a treatment with no active medicine) to compare their effects. The study lasts about a year, and treatment assignment is random. It seeks individuals with a BMI of 30 or higher, or a BMI of 27 or higher with health issues like high blood pressure or sleep apnea. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that CagriSema is generally safe for individuals trying to lose weight, although some side effects have been reported. In earlier studies, 92.3% of participants experienced side effects, with the most common being stomach issues like nausea and vomiting. However, these symptoms were less severe than those from similar treatments. Two deaths were reported, but they were found to be unrelated to the treatment. These findings suggest that while many people tolerate CagriSema well, awareness of possible side effects is important.12345

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about CagriSema for obesity because it combines two active ingredients that work together to potentially enhance weight loss. Unlike standard obesity treatments, which often target a single pathway, CagriSema utilizes a dual mechanism that may improve metabolism and appetite control more effectively. Additionally, the treatment is administered via a weekly injection, which could be more convenient than daily medications. This innovative approach has the potential to provide better results for those struggling with obesity.

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

Research has shown that CagriSema can help people with obesity lose a significant amount of weight. One study found that adults without diabetes lost up to 22.7% of their body weight, while those with type 2 diabetes lost up to 15.7%. Another study reported that 43% of participants lost 15% or more of their body weight. CagriSema proved more effective than semaglutide, another weight-loss drug, resulting in weight loss of up to 14.2%. In this trial, participants will receive either CagriSema in different devices or a placebo to further evaluate its effectiveness as a strong option for weight loss.13567

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 study is for individuals with excess body weight or obesity. Participants will be randomly selected to receive one of two versions of an injectable medication called CagriSema, or a placebo, without knowing which they are receiving.

Inclusion Criteria

I am either male or female by birth.
I am 18 years old or older.
My BMI is 30 or higher, or it's 27 or higher with a condition like high blood pressure.

Exclusion Criteria

Glycosylated haemoglobin (HbA1c) >= 6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening
I have a history of diabetes.
Previous exposure to CagriSema in a clinical study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CagriSema or placebo subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose, then continue the same dose for up to 44 weeks

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CagriSema

Trial Overview

The trial is testing the effectiveness of CagriSema in aiding weight loss among obese individuals. Two different types of injection devices are being compared over a year-long period, with treatments assigned randomly.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: CagriSema in device 1 + Placebo in device 2Experimental Treatment1 Intervention
Group II: CagriSema B in device 2 + Placebo in device 1Experimental Treatment1 Intervention
Group III: Placebo in device 1 + Placebo in device 2Placebo Group1 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 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.

Novo Nordisk A/S: CagriSema demonstrated superior ...

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% ...

New drug CagriSema leads to 14% weight loss in trial

A new 68-week trial found that weekly injections with CagriSema resulted in weight loss of up to 14.2% compared with 10.2% for semaglutide ...

Significant body weight reduction with cagrilintide ...

At week 68, CagriSema produced a significantly greater percentage of body weight loss compared to placebo. The co-primary endpoint—the ...

NCT07011667 | A Research Study to Look at How Well ...

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: ...

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.

Novo Nordisk files for FDA approval of CagriSema, the first ...

CagriSema resulted in greater weight loss of 22.7% at 68 weeks ... Safety data generated in the REDEFINE 1 and 2 trials was comparable ...