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Amylin Analog

CagriSema vs. Tirzepatide for Weight Loss in Obesity

Phase 3
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 78)
Awards & highlights

Study Summary

This trial will compare an investigational medicine (CagriSema) to another (Tirzepatide) to see if either can help lower body weight. Participants will get weekly injections for about 1.5 years.

Who is the study for?
This trial is for adults with obesity, defined as having a BMI of 30 or higher. It's not suitable for people who have diabetes (type 1 or type 2) or those with an HbA1c level of 6.5% or more, which indicates high blood sugar levels.Check my eligibility
What is being tested?
The study compares the effectiveness of CagriSema—a combination of two drugs, Cagrilintide and Semaglutide—with Tirzepatide in helping individuals lose weight. Participants will self-administer weekly injections using a pen injector over approximately one and a half years.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea, injection site reactions such as redness or pain, increased heart rate, and possibly low blood sugar levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 78)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 78) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative change in body weight
Secondary outcome measures
Achievement of greater than or equal to (≥) 25% weight reduction
Achievement of ≥ 30% weight reduction
Change in diastolic blood pressure (DBP)
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CagriSema 2.4 mg/2.4 mgExperimental Treatment2 Interventions
Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 72 weeks.
Group II: Tirzepatide 15 mgActive Control1 Intervention
Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 72 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
1,514 Previous Clinical Trials
2,414,268 Total Patients Enrolled
141 Trials studying Obesity
131,238 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,026 Total Patients Enrolled
28 Trials studying Obesity
48,725 Patients Enrolled for Obesity

Frequently Asked Questions

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

In what areas is this research study available?

"The current trial has 42 sites situated across the USA, including in Montgomery, Costa Mesa and Walnut Creek. To reduce travel time should you decide to take part, please select a site nearest to your residence."

Answered by AI

Has the FDA sanctioned CagriSema 2.4 mg/2.4 mg for use?

"Drawing from prior clinical research, CagriSema 2.4 mg/2.4 mg has been assessed to be a 3 on the safety scale due it's Phase 3 status which implies that there is evidence of efficacy and multiple studies attesting to its security."

Answered by AI

Is recruitment for participation in this investigation currently open?

"This clinical trial, first published on November 15th 2023 and last updated on November 9th, is not presently looking for participants. However, 1025 other medical trials are currently seeking enrolment from the public."

Answered by AI

Who else is applying?

What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Unable to lose weight. I've tried several diets with no luck. I want to lose weight and get healthy.
PatientReceived 2+ prior treatments
I want to see if it may help with weight management. I have tried multiple diet programs without success.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

When will the trial begin? How long do the visits take? Is the screening process over many days?
PatientReceived 1 prior treatment
How often and how long are the screening visits? How many screening visits are there and when will they take place?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
2023. "A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06131437.
All > Paid Studies Seattle > Honolulu
~533 spots leftby Aug 2025
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