Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

New drug combo CagriSema tested against Tirzepatide for Type 2 Diabetes

NCT: NCT06221969 · Status: ACTIVE NOT RECRUITING · Phase: Phase 3 · Sponsor: Novo Nordisk A/S · Started: 2024-01-16 · Est. Completion: 2026-04-03

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 With or Without an SGLT2 Inhibitor is a Phase 3 clinical trial sponsored by Novo Nordisk A/S studying Type 2 Diabetes. This study tests a new combination drug called CagriSema against an existing drug, Tirzepatide, to see which is better at lowering blood sugar and body weight in people with Type 2 Diabetes. It is for adults with Type 2 Diabetes who are already taking metformin (with or without another diabetes medication) and whose blood sugar is not well controlled. Participants will receive either CagriSema or Tirzepatide by injection once a week for about 1.5 years. Treatment assignment is random. Alternative treatments include continuing current metformin therapy, adding other diabetes medications, or switching to Tirzepatide if prescribed by a doctor. The trial aims to enroll 1000 participants.

Official Summary

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

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. Must be taking metformin (with or without an SGLT2 inhibitor) for at least 90 days, with blood sugar levels between 7.0% and 10.5% (HbA1c). Must have a BMI of 30 or higher. Cannot join if pregnant, breastfeeding, planning to become pregnant, or not using effective contraception; or if they have severe kidney problems (eGFR < 30) or uncontrolled eye complications from diabetes. This trial is studying Type 2 Diabetes, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how much the drugs lower your HbA1c (a measure of average blood sugar over 3 months) and your body weight, indicating how well the treatments control your diabetes and hel The specific primary outcome measures are: Change in glycated haemoglobin (HbA1c) (From baseline (week 0) to end of treatment (week 68)); Relative change in body weight (From baseline (week 0) to end of treatment (week 68)). 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 is important because it seeks to find a more effective treatment for Type 2 Diabetes by comparing a novel combination therapy against a leading existing treatment, addressing the need for b 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 Type 2 Diabetes, where improved treatment options are needed.

Investor Insight

This trial represents a significant investment in the competitive obesity and diabetes market, with Novo Nordisk testing a potential next-generation therapy against a strong competitor, suggesting hig Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if CagriSema or Tirzepatide are appropriate for you and what the potential benefits and risks are. Understand that you will receive one of the two study drugs by injection weekly for about 1.5 years, and your treatment will be decided by chance. Be prepared for regular clinic visits for check-ups, blood tests, and injections. 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 ≥ 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 with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
* HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
* 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.

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 \< 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 medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are 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 NCT06221969?

NCT06221969 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 With or Without an SGLT2 Inhibitor." It is currently active, not recruiting and is sponsored by Novo Nordisk A/S. The trial targets enrollment of 1000 participants.

What conditions does NCT06221969 study?

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

What treatments are being tested in NCT06221969?

The interventions being studied include: Cagrilintide (DRUG), Semaglutide (DRUG), Tirzepatide (DRUG). Cagrilintide will be administered subcutaneously.

What does Phase 3 mean for NCT06221969?

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 NCT06221969?

This trial is currently "Active, Not Recruiting." It started on 2024-01-16. The estimated completion date is 2026-04-03.

Who is sponsoring NCT06221969?

NCT06221969 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 NCT06221969?

The trial aims to enroll 1000 participants. The trial status is active, not recruiting.

How is NCT06221969 designed?

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

What are the primary outcomes being measured in NCT06221969?

The primary outcome measures are: Change in glycated haemoglobin (HbA1c) (From baseline (week 0) to end of treatment (week 68)); Relative change in body weight (From baseline (week 0) to end of treatment (week 68)). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06221969 being conducted?

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

Where can I find official information about NCT06221969?

The official record for NCT06221969 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06221969. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06221969 testing in simple terms?

This study tests a new combination drug called CagriSema against an existing drug, Tirzepatide, to see which is better at lowering blood sugar and body weight in people with Type 2 Diabetes. It is for adults with Type 2 Diabetes who are already taking metformin (with or without another diabetes medication) and whose blood sugar is not well controlled.

Why is this trial significant?

This trial is important because it seeks to find a more effective treatment for Type 2 Diabetes by comparing a novel combination therapy against a leading existing treatment, addressing the need for b 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 NCT06221969?

Common side effects may include nausea, vomiting, diarrhea, constipation, and abdominal pain, which are typical for these types of medications. There is a risk of more serious side effects such as pancreatitis, gallbladder problems, or severe allergic reactions, though these are less common. Potential for hypoglycemia (low blood sugar), especially if combined with other diabetes medications that can lower blood sugar. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06221969?

Ask your doctor if CagriSema or Tirzepatide are appropriate for you and what the potential benefits and risks are. Understand that you will receive one of the two study drugs by injection weekly for about 1.5 years, and your treatment will be decided by chance. Be prepared for regular clinic visits for check-ups, blood tests, and injections. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06221969 signal from an investment perspective?

This trial represents a significant investment in the competitive obesity and diabetes market, with Novo Nordisk testing a potential next-generation therapy against a strong competitor, suggesting hig 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 either CagriSema or Tirzepatide by injection once a week for about 1.5 years. Treatment assignment is random. 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.