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Combination Therapy

CagriSema for Obesity

Phase 3

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age above or equal to 18 years at the time of signing informed consent

Be older than 18 years old

Must not have

History of type 1 or type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to end of study (week 74)

Awards & highlights

Pivotal Trial

Summary

"This trial will examine the effectiveness of a new medication called CagriSema in helping people with excess body weight lose weight. CagriSema is a combination of two medications developed by Nov

Who is the study for?

This trial is for individuals with excess body weight, commonly referred to as obesity. Participants will be randomly assigned to receive either the experimental medication CagriSema or a placebo (dummy medicine) and will participate in the study for approximately 1½ years.

What is being tested?

The effectiveness of different doses of CagriSema, a new combination drug made up of cagrilintide and semaglutide by Novo Nordisk, is being tested. The goal is to determine how well it helps people lose weight compared to a placebo.

What are the potential side effects?

Potential side effects are not specified here but may include reactions typical of weight loss medications such as gastrointestinal issues, changes in appetite, fatigue, or injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of diabetes (type 1 or 2).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of study (week 74)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to end of study (week 74)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 74) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of ≥5% weight reduction

Relative change in body weight

Secondary study objectives

Achievement of ≥10% weight reduction

Achievement of ≥15% weight reduction

Achievement of ≥20% weight reduction

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CagriSema Dose 1Experimental Treatment2 Interventions

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks.

Group II: CagriSema Dose 2Active Control2 Interventions

Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.

Group III: Placebo Dose 2Placebo Group1 Intervention

Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.

Group IV: Placebo Dose 1Placebo Group1 Intervention

Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160