Cagrilintide for Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: Amylin-agonists

Disqualifiers: Age, BMI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical study is to compare 2 different versions cagrilintide and see how these work in people living with excess body weight. Participant will get either cagrilintide B or cagrilintide D injections. Which treatment participant will get is decided by chance. Participant will be in this clinical study for about 14 weeks.

Who Is on the Research Team?

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.

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?

Group I: Cagrilintide D Experimental Treatment 1 Intervention

Participants will receive cagrilintide D subcutaneously once weekly for 5 weeks.

Group II: Cagrilintide B Experimental Treatment 1 Intervention

Participants will receive cagrilintide B subcutaneously once weekly for 5 weeks.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen