CagriSema + Semaglutide for Obesity

Not yet recruiting at 300 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must not be taking: GLP-1 RAs, Amylin analogues

Disqualifiers: Recent weight change, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 72 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 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?

Inclusion Criteria

I am 18 years old or older.

My sex assigned at birth is male or female.

BMI≥ 35.0 kg/m^2

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

How Is the Trial Designed?

Group I: Cagrisema - dose level 1 Experimental Treatment 1 Intervention

Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.

Group II: Cagrisema - dose level 2 Active Control 1 Intervention

Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.

Group III: Semaglutide Active Control 1 Intervention

Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 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