BridgeMD
A study to test whether BI 456906 helps people living with overweight or obesity who do not have diabetes to lose weight
EU CTIS ID: 2022-502529-17-00
What this study is testing
This trial aims to investigate efficacy, safety, and tolerability of survodutide as an adjunct to a reduced-calorie diet and increased physical activity in comparison to placebo in trial participants with a BMI ≥30 kg/m^2 or a BMI ≥27 kg/m^2 with at least one weight-related complication but without T2DM. Primary objective is to demonstrate superiority of survodutide low and high dose against placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- BMI ≥30 kg/m² at screening, OR BMI ≥27 kg/m² with the presence of at least one of the following weight-related complications (treated or untreated): - Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, SBP values of ≥140 mmHg and/or DBP values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) - Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or LDL cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or HDL cholesterol <40 mg/dL (<1.0 mmol/L) for men or HDL cholesterol <50 mg/dL (<1.3 mmol/L) for women) - Obstructive sleep apnoea - CVD (e.g. HF with NYHA functional class II-III, history of ischaemic or haemorrhagic stroke or cerebrovascular revascularisation procedure [e.g. carotid endarterectomy and/or stent], MI, coronary artery disease, or peripheral vascular disease) - NASH, as assessed in medical records by histological liver assessment (within the last 6 months)
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Further inclusion criteria apply.
You likely can't join if
- Body weight change (self-reported) of >5% within 3 months before screening
- Trial participants who demonstrate recent evidence (within 3 months prior to screening) of acute or unstable cardiovascular events, e.g. hospitalisation for HF, acute coronary syndrome, unstable angina, MI, ischaemic or haemorrhagic stroke, transient ischaemic attack, and/or acute peripheral vascular event
- Further exclusion criteria apply.
- Treatment with any medication for the indication obesity within 3 months before screening
- HbA1c ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening
- History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before the screening visit up to and including the randomisation visit
See the full eligibility criteria
- Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- BMI ≥30 kg/m² at screening, OR BMI ≥27 kg/m² with the presence of at least one of the following weight-related complications (treated or untreated): - Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, SBP values of ≥140 mmHg and/or DBP values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) - Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or LDL cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or HDL cholesterol <40 mg/dL (<1.0 mmol/L) for men or HDL cholesterol <50 mg/dL (<1.3 mmol/L) for women) - Obstructive sleep apnoea - CVD (e.g. HF with NYHA functional class II-III, history of ischaemic or haemorrhagic stroke or cerebrovascular revascularisation procedure [e.g. carotid endarterectomy and/or stent], MI, coronary artery disease, or peripheral vascular disease) - NASH, as assessed in medical records by histological liver assessment (within the last 6 months)
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Further inclusion criteria apply.
- Body weight change (self-reported) of >5% within 3 months before screening
- Trial participants who demonstrate recent evidence (within 3 months prior to screening) of acute or unstable cardiovascular events, e.g. hospitalisation for HF, acute coronary syndrome, unstable angina, MI, ischaemic or haemorrhagic stroke, transient ischaemic attack, and/or acute peripheral vascular event
- Further exclusion criteria apply.
- Treatment with any medication for the indication obesity within 3 months before screening
- HbA1c ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening
- History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before the screening visit up to and including the randomisation visit
- QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
- HF with NYHA functional class IV
- Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction)
- History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase >2x upper limit of normal (ULN) as measured by the central laboratory at screening
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Democratic People's Republic of
- Australia
- United Kingdom
- United States
- Canada
- Japan
- China
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Democratic People's Republic of; Australia; United Kingdom; United States; Canada; Japan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.