VICTORION-2PREVENT: Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

This Phase III clinical trial is a randomized, double-blind, parallel group, placebo-controlled, multi-center, event-driven study.

The focus of the study is on patients with cardiovascular disease who have not been able to reach a target LDL level of less than 1.4 using statins and ezetimibe. These patients will be randomly assigned to receive either a placebo or Incliseran injections every 6 months. Incliseran is a small interfering RNA that works to inhibit the formation of PCSK9. The primary endpoint being studied is the occurrence of cardiovascular death, myocardial infarction, and ischemic stroke.

Study participants. In total, 17,008 out of the planned 18,000 patients (men and women) aged 40 years or older have enrolled worldwide (997 locations). At Drammen Hospital, 10 out of excpected 10 patients have participated.

Coordinating national research site: Oslo University Hospital HF

Project leader at Vestre Viken HF, Drammen Hospital Trust is Erik Gjertsen MD, and key study personnel are Jonas Pivoriunas MD and Anja Lia-Engene, study coordinator and cardiology nurse.

Sponsors and Collaborators: Novartis Pharmaceuticals

Study duration: October 2022-Juni 2029

Status: Active study, patient recruitment is closed.

For details about the study, please visit: ClinicalTrials.gov ID: NCT05030428

OCEANIC-AF: A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

This Phase III clinical trial is a multi-center, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm study. 

Asundexian, a factor XIa inhibitor, is utilized in the treatment of patients with atrial fibrillation to prevent stroke and systemic embolism. Additionally, Asundexian can be used to prevent ischemic stroke in patients who have previously experienced an acute non-cardioembolic ischemic stroke or are at high risk of TIA when used in conjunction with antiplatelet therapy. The objective of this study is to evaluate the safety and efficacy of Asundexian compared to the approved medication apixaban.

Patients with non-reversible atrial fibrillation and a CHADS-VASc score of greater than 3 are being enrolled in a clinical trial where they will be randomly assigned to receive treatment with either Eliquis, a factor Xa inhibitor, or Asundexian, a factor XIa inhibitor. The primary endpoint being studied is the occurrence of cardiovascular death, myocardial infarction, and ischemic stroke.

Study participants. In total, 14,830 out of the planned 16,000 patients (men and women) aged 18 years or older have enrolled worldwide (1037 locations). At Drammen Hospital, 20 out of excpected 20 patients have participated.

Coordinating national research site: Oslo University Hospital HF

Project leader at Vestre Viken HF, Drammen Hospital Trust is John Munkhaugen MD, and key study personnel are Jonas Pivoriunas MD, Lisa Selmer MD, and Anja Lia-Engene, study coordinator and cardiology nurse.

Sponsor : Bayer Pharma AG

Study duration: December 2022-Januar 2024

Status: Recommendation to stop the study, patient recruitment is terminanted.

For details about the study, please visit: ClinicalTrials.gov ID: NCT05643573

RESULTATER:

Asundexian versus Apixaban in Patients with Atrial Fibrillation. The New England Journal of Medicine (NEJM) 2025.  OCEANIC-AF Steering Committee and Investigators: From Norway John Munkhaugen, Drammen sykehus, MED/NORCOR.

SYNCHRONIZE™ – CVOT: A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity.

This Phase III clinical trial is a multi-center, international, randomised, double-blind, parallel-group, event-driven, cardiovascular safety study. 

The objective of this study is to determine the potential impact of taking the medication survodutide (BI 456906) on individuals who are overweight or obese, specifically in relation to their likelihood of developing serious cardiovascular issues.

Patients who are overweight or obese and have existing cardiovascular disease (CVD) or chronic kidney disease, along with at least two weight-related complications or risk factors for CVD, will be randomly assigned to receive either a 3.6 mg injection of survodutide once weekly, a 6.0 mg injection of survodutide once weekly, or a placebo injection once weekly.The primary endpoint being studied is the occurrence of CV death, non-fatal stroke, non-fatal MI, and ischaemia related coronary revascularisation,

Study participants. In total, an estimated 4,935 patients, including both men and women aged 18 years or older and have BMI≥ 27 kg/m2 are expected to be enrolled in the study at 513 locations worldwide. At Drammen Hospital, it is anticipated that 8 patients will be participating in the study.

Coordinating national research site: Akershus University Hospital HF

Project leader at Vestre Viken HF, Drammen Hospital Trust is Stina Therese Sollid MD, and key study personnel are Jonas Pivoriunas MD, Mari Dyrkorn and Elin Dignes, study coordinators.

Sponsors and collaborators : Boehringer Ingelheim

Study duration: November 2023-March 2026

Status: Active study, recruiting patients.

For details about the study, please visit: ClinicalTrials.gov ID NCT06077864

COMBINE – 1: A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec

This Phase III clinical trial is a randomized, parallel group, multi-center study.

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes. The primary endpoint being studied is change in glycated haemoglobin (HbA1c).

Study participants. In total, 1,291 out of the planned 2,000 patients (men and women) aged 18 years or older have enrolled worldwide (210 locations). At Drammen Hospital, 6 out of excpected 5 patients have participated.

Coordinating national research site: Innlandet Hospital HF

Project leader at Vestre Viken HF, Drammen Hospital Trust is Stina Therese Sollid MD, and key study personnel is Mari Dyrkorn, study coordinator.

Sponsors and collaborators : Novo Nordisk A/S

Study duration: June 2022-May 2024

Status: Active study, recruiting patients.

For details about the study, please visit: ClinicalTrials.gov ID NCT05352815

(RENEW 2) Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

Official Title: Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes

Status: Active study, Not yet recruiting (per 27.10.2025)

Phase III clinical trial

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Study participants. Men and women aged 18 years or older. At Drammen Hospital, expected recruitment of eight patients.

Project leader at Vestre Viken HF, Drammen Hospital Trust is Stina Therese Sollid MD.

Study duration: November 2025-July 2027

Sponsors and collaborators : Novo Nordisk A/S

For details about the study, please visit: ClinicalTrials.gov ID NCT07220759

A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

Official Title

A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease

Status: Active study, Not yet recruiting (per 27.10.2025)

Phase III clinical trial

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.

Study participants. Men and women aged 18 years or older. At Drammen Hospital, expected recruitment of eight patients.

Project leader at Vestre Viken HF, Drammen Hospital Trust is Jonas Pivoriunas MD.

Study duration: July 2025-December 2029

Sponsors and collaborators : Boehringer Ingelheim

For details about the study, please visit: ClinicalTrials.gov ID NCT07064473

Combined Dose Finding and CV Outcoms study with CSL300 ( Clazakizumab) in Adult Subjects with ESKD Undergoing Dialysis (POSIBIL6ESKD) 

Official Title: A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

Status: Active study, recruiting (per 27.10.2025)

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Study participants. Men and women aged 18 years or older. At Drammen Hospital, expected recruitment of five patients.

Project leader at Vestre Viken HF, Drammen Hospital Trust is Jonas Pivoriunas MD, and key study personnel is Morten Reier-Nilsen MD

Study duration: October 2022-August 2029

Sponsors and collaborators : Boehringer Ingelheim

For details about the study, please visit: ClinicalTrials.gov ID NCT05485961