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Cagrilintide for Obesity

Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Novo Nordisk A/S
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two versions of a treatment called cagrilintide, an injectable medication, to evaluate their effectiveness in aiding weight loss for individuals with excess body weight. Participants will receive weekly injections of either cagrilintide B or cagrilintide D for five weeks, with the specific treatment assigned randomly. This study suits adults with a body mass index (BMI) between 27.0 and 34.9, indicating overweight status due to extra body fat. The study spans approximately 14 weeks, during which researchers will monitor health changes. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

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

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

Research has shown that cagrilintide, the treatment under study, is generally well-tolerated by individuals who are overweight. One study found that cagrilintide significantly aided weight loss and was well-received by patients. However, some participants experienced side effects, primarily digestive issues like nausea. In another study, about 72.5% of those taking cagrilintide with another medication reported digestive issues, compared to 34.4% in the placebo group. Additionally, cagrilintide alone posed a higher risk of serious side effects compared to another weight-loss drug. This suggests that while the treatment may aid weight loss, it can cause side effects that some might find uncomfortable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about cagrilintide for obesity because it offers a novel approach to weight management. Unlike other treatments that mainly target appetite suppression through the gut-brain axis, cagrilintide is a long-acting amylin analog that enhances satiety and slows gastric emptying, potentially leading to more significant weight loss. This unique mechanism of action sets it apart from standard options like GLP-1 agonists or lifestyle modifications, providing a fresh avenue for tackling obesity. Plus, it's administered just once a week via a simple subcutaneous injection, which could make it more convenient for patients compared to daily medications.

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

Earlier research has shown that cagrilintide helps people with obesity lose weight. In one study, participants lost an average of 7 kg more than those who took a placebo over 26 weeks. Another study found that combining cagrilintide with semaglutide led to a 13.7% body weight loss, compared to just 3.4% with a placebo. This trial will evaluate two versions of cagrilintide: Cagrilintide B and Cagrilintide D. These findings suggest that cagrilintide effectively aids in weight loss and is generally well tolerated by patients.12346

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 18-64 who are overweight (BMI between 27 and 34.9) due to excess body fat, and are otherwise healthy based on medical exams and lab tests.

Inclusion Criteria

I meet the main requirements for this study.
* Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cagrilintide B or cagrilintide D injections once weekly for 5 weeks

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cagrilintide B
  • Cagrilintide D

Trial Overview

The study compares two different versions of the drug cagrilintide (B and D), given as injections, to see how they work in people with excess body weight. Participants are randomly assigned to one version for about 14 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cagrilintide DExperimental Treatment1 Intervention
Group II: Cagrilintide BExperimental Treatment1 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); ...

Cagrilintide–Semaglutide in Adults with Overweight or ...

The estimated mean change in body weight from baseline to week 68 was −13.7% in the cagrilintide–semaglutide group and −3.4% in the placebo ...

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- ...

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.

Comparative Efficacy and Safety of Semaglutide, ...

Semaglutide alone results in substantial weight loss with additional glycemic benefits, whereas Cagrilintide is better tolerated but less.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40544432/

Cagrilintide-Semaglutide in Adults with Overweight or ...

The estimated mean change in body weight from baseline to week 68 was -13.7% in the cagrilintide-semaglutide group and -3.4% in the placebo ...