This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,533
once weekly subcutaneous injection, pre-filled syringe
once weekly subcutaneous injection, pre-filled syringe
Cardiology P.C.
Birmingham, Alabama, United States
AMR Daphne
Daphne, Alabama, United States
AMR Mobile
Mobile, Alabama, United States
Mobile Heart Specialists, PC
Mobile, Alabama, United States
The Institute for Liver Health II DBA Arizona Clinical Trials
Chandler, Arizona, United States
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)
Heart failure events (HFE) includes hospitalisation for heart failure (HHF), emergency room visit, urgent care visit, or urgent outpatient heart failure (HF) visit (5-point major adverse cardiac event (5P-MACE)) CV-Cardiovascular MI-Myocardial infarction
Time frame: up to Week 114
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority)
Time frame: up to Week 114
Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72
Time frame: Baseline and at Week 72
Absolute change in waist circumference (cm) from baseline to Week 72
Time frame: Baseline and at Week 72
Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline
KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.
Time frame: At Baseline and at Week 72
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority)
Time frame: up to Week 114
Percentage change in body weight from baseline to Week 72
Time frame: Baseline and at Week 72
Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72
Time frame: Baseline and at Week 72
Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72
Time frame: Baseline and at Week 72
Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72
Time frame: Baseline and at Week 72
Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM)
Time frame: Baseline and at Week 72
Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM
Time frame: Baseline and at Week 72
Time to onset of T2DM in trial participants without T2DM at baseline
Time frame: up to Week 114
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or ischaemia related coronary revascularisation (4-point major adverse cardiac event (4P-MACE))
Time frame: up to Week 114
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or HFE (3P-MACE+ HFE)
Time frame: up to Week 114
Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3P-MACE)
Time frame: up to Week 114
Time to first occurrence of adjudicated CV death or adjudicated HFE
Time frame: up to Week 114
Time to first occurrence of adjudicated CV death or adjudicated HHF
Time frame: up to Week 114
Time to first occurrence of adjudicated HFE
Time frame: up to Week 114
Time to adjudicated CV death
Time frame: up to Week 114
Time to all-cause mortality
Time frame: up to Week 114
Time to first occurrence of adjudicated non-fatal MI
Time frame: up to Week 114
Time to first occurrence of adjudicated non-fatal stroke
Time frame: up to Week 114
Time to first occurrence of adjudicated ischaemia related coronary revascularisation
Time frame: up to Week 114
Achievement of body weight reduction ≥5% from baseline to Week 72
Time frame: Baseline and at Week 72
Achievement of body weight reduction ≥10% from baseline to Week 72
Time frame: Baseline and at Week 72
Achievement of body weight reduction ≥15% from baseline to Week 72
Time frame: Baseline and at Week 72
A composite of death, number of adjudicated HFEs, time to first adjudicated HFE and change from baseline in KCCQ-TSS at 72 weeks assessed by the win ratio in trial participants with HF at baseline
Win ratio will be assessed as below: The primary efficacy endpoint will be analyzed using the clinical benefit approach comparing every participant in the BI 456906 arm to every participant in the placebo arm to determine a winner. A winner in the pair-wise comparison has a delayed time to the occurrence of death; if that cannot be determined, a winner has fewer HFEs; if the number of HFEs is the same a winner has a delayed time to the occurrence of first HFE; if that rule does not determine a winner, a winner has a more favorable (less increase or more decrease) change in KCCQ-CSS between baseline and at 72 weeks, otherwise the pair will be recorded as tied. The estimated net benefit (win ratio is then calculated as the total number of wins in the BI 456906 group across all strata divided by the total number of losses) will be provided. KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better.
Time frame: At baseline and at 72 Weeks
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Clinical Research Institute of Arizona, LLC
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Tempe, Arizona, United States
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