Recruiting

A study to evaluate the effectiveness of NNC0662-0419 and semaglutide in people with type 2 diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with type 2 diabetes, a condition where the body has difficulty managing blood sugar levels. The purpose of the study is to evaluate the effectiveness and safety of different doses of a new medicine called NNC0662-0419. This experimental medication is administered via subcutaneous injection, which means it is injected into the fatty layer of tissue just under the skin.

Participants in the study will receive either the test medication NNC0662-0419, a comparator drug named Ozempic, or a placebo. The study will monitor changes in HbA1c, which is a blood test that shows the average blood sugar levels over the past few months. Additionally, changes in body weight will be observed during the course of the research.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
The study begins with the administration of a test medication called nnc0662-0419 or a comparator medication called ozempic.
The nnc0662-0419 or ozempic is given as a solution for injection through a subcutaneous route, which means the medicine is injected into the fatty tissue just under the skin.
The ozempic medication is provided in a pre-filled pen for injection.
Step 2
Medication administration
The medication is administered once weekly.
The study aims to monitor changes in hba1c, which is a measure of average blood sugar levels over a period of time.
The study also monitors changes in body weight.

Who can join the trial?

7 criteria

You must give your informed consent, which means you agree to participate in the study after being given all the necessary information about it.
Your glycated haemoglobin, also known as HbA1c (a test that measures your average blood sugar levels over the past few months), must be between 7.0% and 10.0%.
You must be able and willing to follow all the rules and steps of the study protocol, which is the official plan that describes how the study will be conducted.
You must be willing to aim for a high weight loss of more than 25% of your starting body weight.
You can be any sex assigned at birth, whether male or female.
You must be between 18 and 75 years old at the time you sign the agreement to join the study.
You must have been diagnosed with type 2 diabetes at least 180 days before the screening process begins.

Who cannot join the trial?

30 criteria

Using any medicine for diabetes (high blood sugar) or obesity (extreme weight) within 90 days before starting, though short-term insulin (a hormone used to manage blood sugar) for up to 14 days is allowed.
Having renal impairment, which means the kidneys are not working well enough to filter blood properly, as measured by a specific test called eGFR.
Having a personal history or a history in close family members of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (specific types of cancer related to the endocrine system, which manages hormones).
Having diabetic retinopathy or maculopathy, which are eye problems caused by diabetes that are not under control or are unstable.
Having a myocardial infarction (heart attack), stroke, transient ischaemic attack (a temporary blockage of blood to the brain), or being hospitalized for unstable angina pectoris (chest pain caused by reduced blood flow to the heart) within the last 180 days.
Having chronic heart failure classified as NYHA Class IV, which is a severe stage where the heart cannot pump enough blood for daily activities.
Planning to have revascularisation, which is a procedure to restore blood flow to the arteries (blood vessels) in the heart, neck, or limbs.
Having or having had malignant neoplasms (cancerous tumors), tumors that could affect the endocrine system, or carcinoma in situ (early-stage cancer that has not spread) within the last 5 years, except for certain low-risk skin or prostate cancers.
Using any medicine where the ingredients are unknown or not specified within the last 90 days.
Having inadequately treated blood pressure, defined as a high reading of 180/110 or higher.
Planning to make major changes to your lifestyle, such as your eating, exercise, or sleeping habits, during the study.
Having a level of calcitonin (a hormone) that is 50.0 ng/L or higher.
Having hypoglycaemic unawareness, which means you cannot feel the symptoms when your blood sugar drops too low.
Having significant gastrointestinal disorders (stomach or digestive issues) that might change how your body absorbs medicine or nutrients.
Having a condition, or being unwilling or unable to follow the study rules, that might make the study unsafe for you.
Having had a solid organ transplant in the past or currently waiting for one.
Having a known hypersensitivity (an allergic reaction) to the study medicine or its ingredients.
Having frequent, severe episodes of hypoglycaemia (dangerously low blood sugar) within the last year.
Having experienced diabetic ketoacidosis, a serious complication of diabetes where the body produces high levels of blood acids, within the last 180 days.
A history of gastroparesis, which is a condition where the stomach takes too long to empty its contents.
Planning to start or change any medications for more than 14 days that affect weight or glucose metabolism (how the body processes sugar).
Having had or planning to have obesity surgery or using a weight loss device, with certain exceptions for procedures done more than a year ago.
Reporting a change in body weight of more than 5% within the last 90 days.
Having any major surgery scheduled during the study period.
Having previously been part of this specific study or undergoing rescreening for it.
Being pregnant, breastfeeding, intending to become pregnant, or being able to have children without using effective contraception (methods to prevent pregnancy).
Currently participating in any other interventional clinical study (a medical research study involving a treatment).
Using an investigational medicinal product (a medicine being tested in research) within 90 days before the study begins.
Having a history of or currently having pancreatitis (inflammation of the pancreas).
Having mental incapacity, language barriers, or any reason that prevents understanding or cooperating with the study requirements.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
University Of Debrecen
Debrecen, Hungary
Verified
University Of Szeged
Szeged, Hungary

Trial locations

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Investigated drugs

Semaglutide
is a medication used as a comparison in this study to help manage blood sugar levels in people with type 2 diabetes. It is administered through an injection under the skin.
NNC0662-0419
is the experimental medication being tested in this study. It is given as a weekly injection under the skin to see how well it works at controlling blood sugar levels in participants with type 2 diabetes.

Semaglutide

What is already known about the treatment

Semaglutide
This medication is an established treatment for type 2 diabetes that is administered as a solution via a weekly injection under the skin. It belongs to a group of drugs known as GLP-1 receptor agonists, which work by mimicking a natural hormone in the body to increase insulin production and lower blood sugar levels. By acting on specific receptors in the pancreas and brain, it helps regulate glucose and can also assist with appetite control.
NNC0662-0419
This is an experimental substance currently being studied in clinical trials for the treatment of type 2 diabetes and is administered through a weekly injection under the skin. As a drug candidate in development, it is designed to act on specific hormone receptors to help regulate blood sugar levels at a molecular level. It is classified as a potential GLP-1 receptor agonist, aimed at improving how the body manages insulin and glucose.

Investigated diseases

Type 2 diabetes - This is a condition where the body cannot properly use insulin or does not make enough of it. Insulin is a hormone that helps move sugar from the blood into the cells for energy. Over time, sugar builds up in the bloodstream because it cannot enter the cells effectively. This condition often develops gradually as the body becomes less responsive to insulin. As it progresses, the body's ability to regulate blood sugar levels decreases.