← Back to Search

Amylin Analog

CagriSema for Type 2 Diabetes and Obesity (REDEFINE 2 Trial)

Phase 3
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 75)
Awards & highlights

REDEFINE 2 Trial Summary

This trial will study a new medicine to help people with type 2 diabetes and excess body weight to lose weight. Participants will be chosen at random to receive the medicine or a dummy. Women cannot take part if pregnant or planning to be.

Who is the study for?
Adults with type 2 diabetes and a BMI of at least 27.0 kg/m^2 can join this study if they've been on stable oral diabetic medication for the past 90 days and have an HbA1c level between 7%-10%. They shouldn't be pregnant, breastfeeding, or planning pregnancy during the trial. People with severe kidney issues, recent serious hypoglycemia, or unstable diabetic eye problems cannot participate.Check my eligibility
What is being tested?
The trial is testing CagriSema—a new medicine—against placebo versions to see how well it helps people with excess body weight and type 2 diabetes lose weight. Participants will receive either the real drug or a dummy version randomly over about one and a half years.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions related to typical diabetes medications such as digestive discomfort, low blood sugar levels (hypoglycemia), potential injection site reactions, and possible allergic responses.

REDEFINE 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

REDEFINE 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 75)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 75) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of greater than or equal to (≥) 5% weight reduction
Secondary outcome measures
Achievement of HbA1c less than or equal to (≤) 6.5%
Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup
Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score
+31 more

REDEFINE 2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CagriSemaExperimental Treatment2 Interventions
Cagrilintide + semaglutide once weekly
Group II: PlaceboPlacebo Group2 Interventions
Placebo cagrilintide + semaglutide once weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved
Cagrilintide
2023
Completed Phase 1
~150

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,413,829 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
138,589 Total Patients Enrolled

Media Library

Cagrilintide (Amylin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05394519 — Phase 3
Type 2 Diabetes Research Study Groups: Placebo, CagriSema
Type 2 Diabetes Clinical Trial 2023: Cagrilintide Highlights & Side Effects. Trial Name: NCT05394519 — Phase 3
Cagrilintide (Amylin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05394519 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05394519 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new participants still join this research study?

"The clinicaltrial.gov website indicates that this study is no longer looking for patients. Although the last update to the posting was on November 9th, 2022, it looks like the trial originally started on February 1st, 2023. There are 2,573 other trials currently recruiting if you're interested in participating in medical research."

Answered by AI

Are there long-term repercussions to using CagriSema?

"There is some evidence from earlier trials that suggests CagriSema's efficacy and it has undergone multiple rounds of testing for safety, so our team at Power rates its safety a 3."

Answered by AI

How many sites are running this clinical trial?

"To participate in this trial, patients must visit one of the 50 clinical sites. A few locations include Etobicoke, Fullerton and Minneapolis. It is advised that potential enrollees choose the location closest to them to avoid extra travel costs."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Illinois
Texas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
What site did they apply to?
St. Jos Heritage Hlthcr_Fllrtn
Novo Nordisk Investigational Site
Other

Why did patients apply to this trial?

Need to make changes. Would like to contribute. Hopefully this will work to reduce weight.
PatientReceived 1 prior treatment
I want to lose weight and lower my blood sugar. I NEED TO IMPROVE MY LIFE3 WITH MANY PROBLEMS NOW.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is the trial? How many screening visits? How often would I have to come to the facility? Would I administer the medication at home?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
2023. "A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05394519.
All > Honolulu
~382 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top