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.

Triumph-6
This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo.

Triumph 8    
A Phase 3b Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial.

J3R-MC-YDAG
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants with Obesity or Overweight, without Type 2 Diabetes.

AMAZE 1
This is an interventional, 84-week (main phase, on-treatment) followed by a 52-week (extension phase, on-treatment), multi-national, multi-centre, randomised, double-blinded, placebo-controlled, 5-arm study comparing NNC0487-0111 in doses of 1.25 mg, 5 mg, 20 mg or 40 mg versus placebo, all administered once weekly (QW) in subcutaneous (s.c.) injections, all as an adjunct to a reduced-calorie diet and increased physical activity, in participants with obesity.

The purpose of the present study is to investigate the efficacy and safety of NNC0487-0111 currently under development by Novo Nordisk for the weight management indication. Placebo is chosen as a comparator, which is essential to establish the true clinical safety and efficacy of NNC0487-0111 in an unbiased manner. Moreover, the extension phase of this study will give enough time for participants to achieve a weight loss plateau and provide robust data for assessment of weight loss and additional efficacy and safety parameters when comparing NNC0487-0111 to placebo.

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.

Maritime
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity.

J20-MC-EKBG
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event.

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-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.