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Cagrilintide for Obesity

Recruiting at 10 trial locations

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Cagrilintide, an experimental drug, to determine its safety for people who are overweight and cannot tolerate common weight-loss medications. Participants will receive either Cagrilintide or a placebo, a look-alike treatment with no active medicine, without knowing which one they are getting. The trial seeks individuals who have struggled with weight-loss drugs due to stomach-related side effects and have a BMI of 30 or more. The study lasts about 8 months, aiming to determine if Cagrilintide could be a viable alternative for others in the future. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, with participants among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any GLP-1 receptor agonist medications at least 8 weeks before screening and any diabetes or weight management medications within 90 days before screening.

Is there any evidence suggesting that Cagrilintide is likely to be safe for humans?

Research has shown that Cagrilintide is generally well-tolerated by people who are overweight or obese. In studies, many participants handled the treatment well at various doses. This treatment produced weight loss results similar to those of drugs like semaglutide and liraglutide, but with less reported vomiting. However, the chance of serious side effects was slightly higher compared to some other treatments. It is important to note that this trial is in an early phase, so the treatment's safety is still under investigation, although earlier research offers promising safety information.12345

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

Unlike standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or surgeries such as gastric bypass, Cagrilintide offers a novel approach. This drug is unique because it acts as an amylin analogue, a hormone that helps regulate appetite and food intake. Researchers are excited about Cagrilintide because it could provide a more effective way to control hunger, potentially leading to significant weight loss. Its distinct mechanism of action targeting appetite regulation sets it apart from current options, making it a promising new player in obesity management.

What evidence suggests that Cagrilintide might be an effective treatment for obesity?

Research has shown that Cagrilintide can aid weight loss in people with obesity. In this trial, participants will receive either Cagrilintide or a placebo for 26 weeks. One study found that participants taking Cagrilintide lost an average of 7 kg more than those on a placebo over the same period. Another study reported an average weight loss of 11.8% with Cagrilintide. These findings suggest that Cagrilintide effectively helps individuals who are overweight or have obesity to lose weight.13467

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 people who are overweight or have obesity and could not tolerate GLP-1 medications because of stomach-related side effects. Participants must meet certain health requirements to join.

Inclusion Criteria

Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2)
I am 18 years old or older.
My sex at birth is male or female.
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Exclusion Criteria

Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening
I have taken weight loss medication in the past 8 weeks.
I have been diagnosed with diabetes.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cagrilintide or placebo for 26 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cagrilintide

Trial Overview

The study compares Cagrilintide, a new weight-loss medicine, with a placebo (inactive treatment). Participants are randomly assigned to one group and will be followed for about 8 months to check safety and tolerability.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: CagrilintideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo 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

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

At 26 weeks, cagrilintide 2.4 mg had a significantly greater reduction in body weight as compared to placebo [MD − 7.00 kg (95% CI: −7.17, −6.83); ...

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 ...

3.

mediacenteratypon.nejmgroup-production.org

mediacenteratypon.nejmgroup-production.org/NEJMoa2502081.pdf

Coadministered Cagrilintide and Semaglutide in Adults with ...

On the basis of the treatment-policy estimand, the mean percent body-weight reduction at week. 68 was −20.4% with cagrilintide–semaglutide and.

REDEFINE 1 Trial Finds Cagrilintide–Semaglutide Combo ...

In the REDEFINE 1 trial, 60% of participants receiving once-weekly CagriSema (cagrilintide–semaglutide) achieved at least 20% weight loss, and ...

Once-weekly cagrilintide for weight management in people ...

Treatment with cagrilintide in people with overweight and obesity led to significant reductions in bodyweight and was well tolerated.

Efficacy and safety of cagrilintide 2.4 mg in adults with ...

Efficacy and safety of cagrilintide 2.4 mg in adults with overweight/obesity: Data from REDEFINE 1. W. Timothy Garvey1*, Lei Liu2, John ...

Study Details | NCT07220642 | Weight Loss in People ...

This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational ...