CagriSema for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Type 2 Diabetes Mellitus+5 More
Cagrilintide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Eligible Conditions
  • Type 2 Diabetes Mellitus
  • Overweight
  • Obesity
  • Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Type 2 Diabetes Mellitus

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: From baseline (week 0) to end of treatment (week 68)

Week 68
Achievement of greater than or equal to 5% weight reduction
Achievement of ≥ 20% weight reduction
Body Weight Changes
Change in Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning score
Change in Systolic Blood Pressure (SBP)
Change in waist circumference
Week 20
Relative change in body weight

Trial Safety

Safety Progress

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

Other trials for Type 2 Diabetes Mellitus

Trial Design

2 Treatment Groups

CagriSema
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

1200 Total Participants · 2 Treatment Groups

Primary Treatment: CagriSema · Has Placebo Group · Phase 3

CagriSemaExperimental Group · 2 Interventions: Cagrilintide, Semaglutide · Intervention Types: Drug, Drug
PlaceboPlaceboComparator Group · 2 Interventions: Placebo cagrilintide, Placebo semaglutide · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cagrilintide
2021
Completed Phase 1
~40
Semaglutide
2019
Completed Phase 4
~5560

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (week 0) to end of treatment (week 68)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,390 Previous Clinical Trials
2,292,403 Total Patients Enrolled
55 Trials studying Type 2 Diabetes Mellitus
12,427 Patients Enrolled for Type 2 Diabetes Mellitus
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
54,901 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) greater than or equal to 27.0 kg/m^2.
You have type 2 diabetes mellitus greater than or equal to 180 days before screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: October 6th, 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.