Effect of CagriSema, Semaglutide and Cagrilintide on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes

Trial tests new diabetes drug combination for type 2 diabetes patients.

NCT: NCT06403761 · Status: COMPLETED · Phase: Phase 1 · Sponsor: Novo Nordisk A/S · Started: 2024-05-06 · Est. Completion: 2026-02-02

Plain English Summary

Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes is a Phase 1 clinical trial sponsored by Novo Nordisk A/S studying Diabetes Mellitus, Type 2. This study tests CagriSema, a new combination drug, against its individual components (semaglutide, cagrilintide) and a placebo in adults with type 2 diabetes. It is for adults aged 18-75 with type 2 diabetes who are already taking metformin. Participants will receive one of the study drugs or a placebo alongside their current metformin, and will be monitored for about 42 weeks. Alternatives include continuing current diabetes medications or participating in other clinical trials. The trial aims to enroll 158 participants.

Official Summary

This study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D). CagriSema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. Doctors may not yet prescribe CagriSema. Participants will either get CagriSema, semaglutide, cagrilintide, or a ''dummy'' medicine. Which treatment the participants will get is decided by chance. Participants will get the study medicine together with the current daily diabetes medicine metformin. Participants should not take other medicines for diabetes during the study. The study will last for about 42 weeks.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 75 years old and have had type 2 diabetes for at least 6 months. You must be taking metformin, with or without one other diabetes pill (but not GLP-1 or SGLT-2 inhibitors unless you have specific heart or kidney conditions). Your blood sugar levels (HbA1c) should be within a certain range, and your BMI should be between 25 and 45. You cannot join if you are pregnant, breastfeeding, have severe kidney problems (eGFR < 45), or have uncontrolled diabetic eye disease. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how well the study drugs improve the body's ability to use insulin to control blood sugar, which is crucial for managing type 2 diabetes. The specific primary outcome measures are: To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC) (Baseline to week 28). 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 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial is important because it investigates a novel combination therapy that could offer a new treatment option for managing type 2 diabetes, addressing a significant unmet need in glycemic contro This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.

Investor Insight

This trial signals strong investor interest in novel diabetes treatments, with Novo Nordisk, a major player, developing CagriSema, a combination drug targeting a large and growing market for type 2 di Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific type 2 diabetes management plan. Be prepared for regular visits for about 42 weeks to receive study medication and undergo tests. You will be taking the study drug along with your current metformin, and will not be allowed to take other diabetes medications during the trial. The trial is being conducted at 1 site. 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.
* Aged 18-75 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 2 diabetes greater than or equal to (\>=) 180 days before screening.
* Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (\<) 60 milliliter per minute per 1.73 square meter \[ml/min/1.73 m\^2\]).
* Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole \[mmol/mol\]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c \>= 7.0 % at screening.
* Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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.
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m\^2 at screening.
* Treatment with any medication for the indication of T2D or weight management 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06403761?

NCT06403761 is a Phase 1 INTERVENTIONAL study titled "Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes." It is currently completed and is sponsored by Novo Nordisk A/S. The trial targets enrollment of 158 participants.

What conditions does NCT06403761 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 NCT06403761?

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

What does Phase 1 mean for NCT06403761?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT06403761?

This trial is currently "Completed." It started on 2024-05-06. The estimated completion date is 2026-02-02.

Who is sponsoring NCT06403761?

NCT06403761 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 NCT06403761?

The trial aims to enroll 158 participants. The trial status is completed.

How is NCT06403761 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06403761?

The primary outcome measures are: To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC) (Baseline to week 28). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06403761 being conducted?

This trial is being conducted at 1 site, including Neuss (Germany).

Where can I find official information about NCT06403761?

The official record for NCT06403761 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06403761. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06403761 testing in simple terms?

This study tests CagriSema, a new combination drug, against its individual components (semaglutide, cagrilintide) and a placebo in adults with type 2 diabetes. It is for adults aged 18-75 with type 2 diabetes who are already taking metformin.

Why is this trial significant?

This trial is important because it investigates a novel combination therapy that could offer a new treatment option for managing type 2 diabetes, addressing a significant unmet need in glycemic contro

What are the potential risks of participating in NCT06403761?

Common side effects may include nausea, vomiting, diarrhea, or constipation, similar to other diabetes medications. There is a risk of developing diabetic retinopathy or maculopathy, which will be monitored. Potential risks include kidney impairment, though participants with severe impairment are excluded. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06403761?

Ask your doctor if this trial is a good fit for your specific type 2 diabetes management plan. Be prepared for regular visits for about 42 weeks to receive study medication and undergo tests. You will be taking the study drug along with your current metformin, and will not be allowed to take other diabetes medications during the trial. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06403761 signal from an investment perspective?

This trial signals strong investor interest in novel diabetes treatments, with Novo Nordisk, a major player, developing CagriSema, a combination drug targeting a large and growing market for type 2 di This is a Phase 1 trial, which is in early development stages.

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

Participants will receive one of the study drugs or a placebo alongside their current metformin, and will be monitored for about 42 weeks. 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.