Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

New Trial Compares CagriSema to Tirzepatide for Type 2 Diabetes

NCT: NCT06534411 · Status: ACTIVE NOT RECRUITING · Phase: Phase 3 · Sponsor: Novo Nordisk A/S · Started: 2024-11-05 · Est. Completion: 2026-07-14

Plain English Summary

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both is a Phase 3 clinical trial sponsored by Novo Nordisk A/S studying Diabetes Mellitus, Type 2. This study tests a new combination drug, CagriSema, against an existing drug, tirzepatide, to see which is better at lowering blood sugar and body weight. It is for adults with type 2 diabetes who are not well-controlled on metformin, an SGLT2 inhibitor, or both. Participants will receive one of the two treatments by injection once a week for about 1 year and 4 months. Alternatives include continuing current medications, lifestyle changes, or other approved diabetes treatments. The trial aims to enroll 1023 participants.

Official Summary

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with type 2 diabetes diagnosed at least 180 days ago. Individuals whose diabetes is not well-controlled with metformin, SGLT2 inhibitors, or both, with an HbA1c between 7.0% and 10.5%. People with a BMI of 30 or higher. Individuals must not have severe kidney problems (eGFR < 30) or uncontrolled eye issues related to diabetes. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how much the study drugs lower your average blood sugar (HbA1c) and reduce your body weight over the course of the study. The specific primary outcome measures are: Change in Glycated Haemoglobin (HbA1c) (From baseline (week 0) to end of treatment (week 60)); Relative Change in Body Weight (From baseline (week 0) to end of treatment (week 60)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial matters because it addresses the need for more effective treatments to manage type 2 diabetes and its associated weight gain, potentially offering a new option for patients with inadequatel As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.

Investor Insight

This trial is a Phase 3 study sponsored by Novo Nordisk, a major pharmaceutical company, indicating significant investment in developing CagriSema, a combination of two existing drug components, for t Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1023 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific diabetes management needs and current health status. You will receive either CagriSema or tirzepatide injections weekly for up to 1 year and 4 months, with regular check-ups and blood tests. Be prepared for regular study visits, which may involve blood draws, physical exams, and answering questions about your health and any side effects. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening.
* Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
* Metformin
* sodium-glucose co-transporter 2 inhibitor (SGLT2i)
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) \>= 30 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.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06534411?

NCT06534411 is a Phase 3 INTERVENTIONAL study titled "A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both." It is currently active, not recruiting and is sponsored by Novo Nordisk A/S. The trial targets enrollment of 1023 participants.

What conditions does NCT06534411 study?

This trial investigates treatments for Diabetes Mellitus, Type 2. The primary condition under study is Diabetes Mellitus, Type 2.

What treatments are being tested in NCT06534411?

The interventions being studied include: Cagrilintide (DRUG), Semaglutide (DRUG), Tirzepatide (DRUG). Participants will receive once-weekly cagrilintide subcutaneously.

What does Phase 3 mean for NCT06534411?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06534411?

This trial is currently "Active, Not Recruiting." It started on 2024-11-05. The estimated completion date is 2026-07-14.

Who is sponsoring NCT06534411?

NCT06534411 is sponsored by Novo Nordisk A/S. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06534411?

The trial aims to enroll 1023 participants. The trial status is active, not recruiting.

How is NCT06534411 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06534411?

The primary outcome measures are: Change in Glycated Haemoglobin (HbA1c) (From baseline (week 0) to end of treatment (week 60)); Relative Change in Body Weight (From baseline (week 0) to end of treatment (week 60)). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06534411 being conducted?

This trial is being conducted at 20 sites, including Pelham, Alabama; Phoenix, Arizona; Tucson, Arizona; Little Rock, Arkansas and 16 more sites (United States).

Where can I find official information about NCT06534411?

The official record for NCT06534411 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06534411. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06534411 testing in simple terms?

This study tests a new combination drug, CagriSema, against an existing drug, tirzepatide, to see which is better at lowering blood sugar and body weight. It is for adults with type 2 diabetes who are not well-controlled on metformin, an SGLT2 inhibitor, or both.

Why is this trial significant?

This trial matters because it addresses the need for more effective treatments to manage type 2 diabetes and its associated weight gain, potentially offering a new option for patients with inadequatel As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06534411?

Common side effects may include nausea, vomiting, diarrhea, constipation, and injection site reactions. There is a risk of low blood sugar (hypoglycemia), especially if you are also taking other diabetes medications. Potential risks include changes in kidney function, gallbladder problems, and pancreatitis, though these are less common. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06534411?

Ask your doctor if this trial is a good fit for your specific diabetes management needs and current health status. You will receive either CagriSema or tirzepatide injections weekly for up to 1 year and 4 months, with regular check-ups and blood tests. Be prepared for regular study visits, which may involve blood draws, physical exams, and answering questions about your health and any side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06534411 signal from an investment perspective?

This trial is a Phase 3 study sponsored by Novo Nordisk, a major pharmaceutical company, indicating significant investment in developing CagriSema, a combination of two existing drug components, for t This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive one of the two treatments by injection once a week for about 1 year and 4 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.