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Amylin analog

CagriSema for Obesity (REDEFINE 1 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study-main part (week 75)
Awards & highlights

REDEFINE 1 Trial Summary

This trial looks at how CagriSema helps people lose weight and related diseases compared to other medicines, with participants taking an injection once a week and followed for 1½ to 2 years.

Who is the study for?
Adults with a BMI of at least 30, or at least 27 with weight-related health issues like high blood pressure or sleep apnea can join. It's not for those who have diabetes or an HbA1c level of 6.5% or higher.Check my eligibility
What is being tested?
The trial is testing CagriSema against placebo and two other drugs, cagrilintide and semaglutide, to see which helps more with weight loss. Participants get one injection weekly by chance and are monitored for about 1.5 years, followed by a 2-year extension study without medication.See study design
What are the potential side effects?
Possible side effects aren't specified here but typically may include reactions at the injection site, gastrointestinal symptoms like nausea or diarrhea, headaches, fatigue, and potential changes in appetite.

REDEFINE 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study-main part (week 75)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study-main part (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
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction
Secondary outcome measures
CagriSema 0.5 mg/0.5 mg versus placebo: Relative change in body weight
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 for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score
+62 more

REDEFINE 1 Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cagrisema s.c. 2.4 mg/2.4 mgExperimental Treatment2 Interventions
Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.
Group II: Semaglutide s.c. 2.4 mgActive Control2 Interventions
Participants will receive semaglutide s.c. 2.4 mg and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.
Group III: Cagrilintide s.c. 2.4 mgActive Control2 Interventions
Participants will receive cagrilintide s.c. 2.4 mg and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks.
Group IV: Placebo s.c.Placebo Group2 Interventions
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.
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
1,513 Previous Clinical Trials
2,411,629 Total Patients Enrolled
141 Trials studying Obesity
128,638 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
136,389 Total Patients Enrolled
28 Trials studying Obesity
46,125 Patients Enrolled for Obesity
Clinical Reporting Office dept. 2834Study DirectorNovo Nordisk A/S
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Obesity
150 Patients Enrolled for Obesity

Media Library

Cagrilintide (Amylin analog) Clinical Trial Eligibility Overview. Trial Name: NCT05567796 — Phase 3
Obesity Research Study Groups: Cagrisema s.c. 2.4 mg/2.4 mg, Semaglutide s.c. 2.4 mg, Placebo s.c., Cagrilintide s.c. 2.4 mg
Obesity Clinical Trial 2023: Cagrilintide Highlights & Side Effects. Trial Name: NCT05567796 — Phase 3
Cagrilintide (Amylin analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05567796 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05567796 — Phase 3

Frequently Asked Questions

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

Are new patients being accepted into this trial at this time?

"Yes, this research is still looking for participants. The trial was posted on November 1st, 2020 and was last updated ten days ago on November 10th."

Answered by AI

In how many different medical clinics is this trial taking place today?

"This trial is currently available at 47 different sites. These include locations in Aurora, Chapel Hill and Hamilton; a full list of other locations can be found on the clinical trials website. Selecting the site nearest to you will help reduce travel-related demands if you choose to participate."

Answered by AI

How many individuals are being monitored as part of this clinical research?

"Yes, this is an active trial that was first posted on November 1st, 2020. The study will enroll 3400 patients from 47 different sites."

Answered by AI

Has Cagrisema s.c. 2.4 mg/2.4 mg received FDA approval?

"Cagrisema s.c. 2.4 mg/2.4 mg is in Phase 3 of clinical trials, which means that while there is data supporting efficacy, multiple rounds of data are needed to support safety. Therefore, we give it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Florida
New Jersey
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Lynn Institute of Norman
Novo Nordisk Investigational Site
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

Why did patients apply to this trial?

I want to lose weight. Difficulty losing weight. I need to loose weight and h.
PatientReceived 1 prior treatment
I need help with weight loss. I’ve tried other drug and it stopped working.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

What the side effects are? How long will I be in the trial? How frequent are the study visits?
PatientReceived 2+ prior treatments
How long does this trial last? What does it entail? Can this trial be conducted virtually? Or are visits to treatment centers required?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
2022. "A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05567796.
All > Honolulu
~739 spots leftby Oct 2024
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