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GLP-1 Receptor Agonist

CagriSema for Type 2 Diabetes

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
Age 18 years or above at the time of signing the informed consent
Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 74)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Study Summary

This trial will test how well a new medicine called CagriSema helps people with type 2 diabetes to lower their blood sugar and body weight. CagriSema is not yet approved

Who is the study for?
This trial is for people with type 2 diabetes who are currently being treated with metformin alone or in combination with an SGLT2 inhibitor. Participants should not be on any other diabetic medications and must have a stable condition to join the study.Check my eligibility
What is being tested?
The study tests CagriSema, a new medication, against Tirzepatide, which is already prescribed in some places. Both drugs aim to lower blood sugar and body weight in diabetics. Patients will receive one of these treatments randomly for up to 18 months.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea, low blood sugar levels (hypoglycemia), possible injection site reactions, and fatigue. The exact side effects will vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My BMI is 30 or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 74)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 74) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in glycated haemoglobin (HbA1c)
Relative change in body weight
Secondary outcome measures
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)
Achievement of greater than or equal to (≥) 5% weight reduction
+19 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CagriSemaExperimental Treatment2 Interventions
Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.
Group II: TirzepatideActive Control1 Intervention
Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 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
1,490 Previous Clinical Trials
2,380,272 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
86 Previous Clinical Trials
107,990 Total Patients Enrolled

Frequently Asked Questions

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

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"This clinical trial is being conducted at various locations, including BSES MG Hospital in Jaipur, J K Lon Hospital and SMS Medical College & Attached Hospitals in Vellore. Additionally, Christian Medical College Hospital in Kolkata is also participating. In total, there are 223 other sites involved in the study."

Answered by AI

What are the potential risks and hazards associated with CagriSema in relation to patient safety?

"The safety of CagriSema is rated as 3 based on our assessment at Power. This rating aligns with the Phase 3 nature of the trial, which indicates that there is evidence supporting its effectiveness and multiple rounds of data demonstrating its safety."

Answered by AI

Are individuals currently able to enroll in this ongoing medical study?

"The information from clinicaltrials.gov indicates that this study is currently not in the recruitment phase. Although it was initially posted on January 16th, 2024 and last updated on January 15th, 2024, there are presently no openings for participants. However, there are a total of 1388 other ongoing clinical trials actively seeking eligible candidates at this time."

Answered by AI

What is the primary objective of conducting this clinical trial?

"Novo Nordisk A/S, the trial sponsor, has identified the primary outcome of this study as the change in glycated haemoglobin (HbA1c) levels. This measurement will be taken from baseline (week 0) to the end of treatment (week 68). The secondary outcomes being assessed include achieving a weight reduction equal to or greater than 5%, changes in systolic blood pressure measured in mmHg, and changes in diastolic blood pressure also measured in mmHg."

Answered by AI

Who else is applying?

What site did they apply to?
St. Jude Heritage Yorba Linda - Pediatric Ste D
Urban Family Practice Assoc
Discovery MM Services, Inc
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I hope the clinical trial will help me with my diabetes . I've tried many drugs and nothing gives me the acceptable levels.
PatientReceived 1 prior treatment
I wish to find a treatment that helps resolve my high blood sugar condition.
PatientReceived 2+ prior treatments
~667 spots leftby Nov 2025