BridgeMD
A study to test whether BI 456906 helps people living with overweight or obesity who also have diabetes to lose weight
EU CTIS ID: 2022-502531-18-00
What this study is testing
This trial aims to investigate the efficacy, safety, and tolerability of survodutide as an adjunct to a reduced-calorie diet and increased physical activity in comparison to placebo in participants with a BMI ≥27 kg/m^2 and 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 ≥27 kg/m^2 at screening
- Diagnosed with T2DM (defined as glycosylated haemoglobin A1c [HbA1c] ≥6.5% [≥48 mmol/mol]) at least 180 days prior to screening
- HbA1c ≥6.5% (≥48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening
- Currently treated for T2DM with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT2i), acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to local label
- History of at least one self-reported unsuccessful dietary effort to lose body weight
You likely can't join if
- Body weight change (self-reported) of >5% within 3 months before screening
- Treatment with any medication for the indication obesity within 3 months before screening
- Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before the screening visit up to and including the randomisation visit (i.e. insulin, amylin analogues, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and dipeptidyl peptidase 4 inhibitor [DPP-4i])
- QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
- Heart failure (HF) with NYHA class IV
- Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction)
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 ≥27 kg/m^2 at screening
- Diagnosed with T2DM (defined as glycosylated haemoglobin A1c [HbA1c] ≥6.5% [≥48 mmol/mol]) at least 180 days prior to screening
- HbA1c ≥6.5% (≥48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening
- Currently treated for T2DM with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT2i), acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to local label
- 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
- Treatment with any medication for the indication obesity within 3 months before screening
- Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before the screening visit up to and including the randomisation visit (i.e. insulin, amylin analogues, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and dipeptidyl peptidase 4 inhibitor [DPP-4i])
- QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
- Heart failure (HF) with NYHA 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 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)
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- New Zealand
- Japan
- United Kingdom
- China
- Korea, Republic of
- United States
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; New Zealand; Japan; United Kingdom; China; Korea, Republic of 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.