Clinical trials

SYNCHRONIZE™-2 (1404-0041)

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight.

REDEFINE 2 

The purpose of this study is to evaluate the effect and safety of a once-weekly administered subcutaneous (s.c) medicine called CagriSema in people living with obesity and T2D. It will be compared to placebo. CagriSema is a new medicine that is being developed by the company Novo Nordisk A/S and is a combination of cagrilintide and semaglutide which have two different modes of action. Combining two anti-obesity medications with different modes of action has the potential of becoming a new preferable option in the treatment of obesity by combining the weight loss benefits of the two medications.

SYNCHRONIZE™-1 (1404-0038)

This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least one health problem related to their weight.

People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. 

REDEFINE 9

The purpose of this study is to compare how well different doses of a medicine called CagriSema can help people to lose weight compared to a dummy medicine (also called placebo). The two strengths of CagriSema will be 1.7mg/1.7mg and 1.0mg/1.0mg.
The study will take place in 6 NHS hospitals. The studies main phase amounts to a total of 77 weeks (up to 3 weeks of screening, 68 weeks of treatment and 6 weeks follow-up) .

The number of people living with excess weight has been increasing in the last 30 years. People living with excess body weight are more likely to get diseases like type 2 diabetes, increased blood pressure and diseases of the heart. Excess body weight is treated with diet and physical activity, but this does not result in weight loss for all people. Some people may need treatment for excess body weight on top of lifestyle changes to lose weight. The study medicine CagriSema is a combination of two medicines named cagrilintide and semaglutide, which may help people to lose weight.

SELECT-LIFE

This SELECT-LIFE (follow-up study) sponsored by Novo Nordisk is an observational, survey-based follow-up study of the participants who were enrolled in SELECT. SELECT is a cardiovascular outcomes trial which started in 2018 aiming to demonstrate that semaglutide 2.4 mg administered by injection under the skin, once weekly lowers the incidence of major adverse cardiovascular events in patients with established cardiovascular disease and overweight or obesity. This was the first clinical trial designed to explore superiority of GLP-1 RA against placebo, in addition to standard of care on reduction of cardiovascular events in a non-diabetic overweight or obese population.

REDEFINE 3

The purpose of this study is to evaluate the effect and safety on the cardiovascular system of a once-weekly injectable medicine called CagriSema in people living with obesity and established cardiovascular disease. Cagrisema is a new medicine that is being developed by the company Novo Nordisk A/S and is a combination of cagrilintide and semaglutide. These medicines work in different ways in the body and have the potential to help treat obesity and impact cardiovascular risk factors.

Obesity is currently one of the most significant and widespread health challenges. People living with obesity are at a high risk of obesity-related complications one of which is cardiovascular disease. Cardiovascular disease affects people’s heart and blood vessels leading to heart attacks, strokes or poor blood circulation.

ZEUS

This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation.

SOUL

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. 

ZOSTER-101

A phase 3b, open-label, multi-country, multi-centre, long-term follow-up study of ZOSTER-049 (follow-up of ZOSTER-006/022 studies) to assess the prophylactic efficacy, safety and persistence of immune response of a Herpes Zoster subunit vaccine and assessment of persistence of immune response and safety of 1 or 2 additional doses administered in ZOSTER-049 in 2 subgroups of older adults

RSV OA=ADJ-006

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus Infections in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

Respiratory Syncytial Virus (RSV) is a highly contagious virus that causes respiratory infections in people of all ages. Mild cases present like a common cold. RSV can lead to serious complications such as pneumonia in older adults. RSV may also worsen some existing conditions such as chronic respiratory or heart diseases.

RSV OA=ADJ-012

This clinical study will involve patients who previously participated in the RSV OA=ADJ-006 (RSV 006) and received either a placebo vaccine or a single dose of the RSV vaccine, to investigate when patients should have a further dose to continue receiving protection from RSV; to give patients that previously received a placebo vaccine in RSV 006 the opportunity to receive the RSV vaccine for the first time; and to collect further safety information on the vaccine.

Participants in the study, following provision of their consent, will undergo initial screening to understand if they are eligible for participation in the study. All patients that previously received a placebo vaccine will be offered the approved RSV vaccine, returning 30 days after the vaccination was administered for assessment, and will have a follow-up call 6 months after the first visit.