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Amylin Analog

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

Novo Nordisk Investigational Site, West Seneca, NY
Targeting 4 different conditionsCagrilintide +3 morePhase 3RecruitingResearch Sponsored by Novo Nordisk A/S

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.

Eligible Conditions
  • Type 2 Diabetes
  • Obesity

REDEFINE 2 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
Both males and females are eligible.
Select...
You have a body mass index (BMI) of 27 or higher.

REDEFINE 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of treatment (week 68)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of treatment (week 68) 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 ≥ 20% weight reduction
Body Weight Changes
Change in Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
+4 more

Awards & Highlights

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

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
Cagrilintide
2023
Completed Phase 1
~150
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,476 Previous Clinical Trials
2,367,376 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
80 Previous Clinical Trials
103,358 Total Patients Enrolled

Media Library

Cagrilintide (Amylin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05394519 — Phase 3
Type 2 Diabetes Research Study Groups: CagriSema, Placebo
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?
Novo Nordisk Investigational Site
Other

Why did patients apply to this trial?

Need to make changes. Would like to contribute. I want to lose weight and lower my blood sugar.
PatientReceived 1 prior treatment
I NEED TO IMPROVE MY LIFE3 WITH MANY PROBLEMS NOW. Wanting to lose weight and lower my A1C levels, so I can be.more active.
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?

Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
Average response time
  • < 2 Days
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 > New York > Honolulu
~655 spots leftby Dec 2024
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