Cagrisema s.c. 2.4 mg/2.4 mg for Obesity

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Obesity
Semaglutide - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 27 Secondary · Reporting Duration: From baseline (week 0) to end of study-main part (week 75)

Week 75
Number of Treatment Emergent Adverse Events (TEAEs)
Number of Treatment Emergent Serious adverse events (TESAEs)
Week 68
Diagnostic radiologic examination
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg; and CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 20% weight reduction
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 25% weight reduction
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 30% weight reduction
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Diastolic Blood Pressure (DBP)
Body Weight Changes
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Glycated Haemoglobin (HbA1c)
Cognitive Therapy
Cognitive Therapy
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score and Mental Component Summary Score
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning Score
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA relative to total body mass
Body Weight Changes
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in Free fatty acids
High Density Lipoproteins
Body Weight Changes
Triglycerides
Lipoproteins
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in fasting serum insulin
Cholesterol
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in visceral fat mass by DXA
Week 20
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
Week 8
CagriSema 0.5 mg/0.5 mg versus placebo: Relative change in body weight

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Semaglutide s.c. 2.4 mg
1 of 4
Cagrilintide s.c. 2.4 mg
1 of 4
Cagrisema s.c. 2.4 mg/2.4 mg
1 of 4
Placebo s.c.
1 of 4

Active Control

Experimental Treatment

Non-Treatment Group

3400 Total Participants · 4 Treatment Groups

Primary Treatment: Cagrisema s.c. 2.4 mg/2.4 mg · Has Placebo Group · Phase 3

Cagrisema s.c. 2.4 mg/2.4 mgExperimental Group · 2 Interventions: Semaglutide, Cagrilintide · Intervention Types: Drug, Drug
Semaglutide s.c. 2.4 mgActiveComparator Group · 2 Interventions: Semaglutide, Placebo cagrilintide · Intervention Types: Drug, Drug
Cagrilintide s.c. 2.4 mgActiveComparator Group · 2 Interventions: Placebo semaglutide, Cagrilintide · Intervention Types: Drug, Drug
Placebo s.c.PlaceboComparator Group · 2 Interventions: Placebo cagrilintide, Placebo semaglutide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5560
Cagrilintide
2021
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (week 0) to end of study-main part (week 75)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,392 Previous Clinical Trials
2,290,593 Total Patients Enrolled
111 Trials studying Obesity
116,169 Patients Enrolled for Obesity
Clinical Reporting Office dept. 2834Study DirectorNovo Nordisk A/S

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: November 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas40.0%
Washington20.0%
Hawaii20.0%
Other20.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Novo Nordisk Investigational Site50.0%
Other50.0%
What portion of applicants met pre-screening criteria?
Met criteria80.0%
Did not meet criteria20.0%
How many prior treatments have patients received?
0100.0%
Why did patients apply to this trial?
  • "I gained extra weight in the last few years. As well, I have been watching my blood pressure as it is on the edge of normal to stage one hypertension. I have been trying unsuccessfully to lose this extra weight so am now considering if medication will help. I am also interested in participating in a clinical trial."
What questions have other patients asked about this trial?
  • "How frequent are the study visits?"

How responsive is this trial?

Typically responds via
Email100.0%
Average response time
  • < 2 Days
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours