A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
- Conditions
- Obesity
- Registration Number
- NCT06066515
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 726
Inclusion Criteria:<br><br> 1. Male or female, age =18 years at the time of signing informed consent, and at least<br> the legal age of consent in countries where it is >18 years<br><br> 2. Body mass index (BMI) =30 kg/m^2 at screening, OR BMI =27 kg/m^2 with the presence<br> of at least one of the obesity-related complications (treated or untreated) e.g,:<br><br> - Hypertension (defined as repeated, i.e. at least 3 measurements in resting<br> condition, systolic blood pressure (SBP) values of =140 millimetre of mercury<br> (mmHg) and/or diastolic blood pressure (DBP) values of =90 mmHg in the absence<br> of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug<br> to maintain a normotensive blood pressure)<br><br> - Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to<br> maintain normal blood lipid levels, or low density lipoprotein (LDL) =160 mg/dL<br> (=4.1 mmol/L), or triglycerides =150 mg/dL (=1.7 mmol/L), or high density<br> lipoprotein (HDL) <40 mg/dL (<1.0 mmol/L) for men or HDL<50 mg/dL (<1.3 mmol/L)<br> for women)<br><br> - Obstructive sleep apnoea<br><br> - Others.<br><br> 3. History of at least one self-reported unsuccessful dietary effort to lose body<br> weight.<br><br>Further inclusion criteria apply.<br><br>Exclusion Criteria:<br><br> 1. Body weight change (self-reported) of >5% within 3 months before screening.<br><br> 2. Treatment with any medication for the indication obesity within 3 months before<br> screening.<br><br> 3. Glycosylated haemoglobin A1c (HbA1c) =6.5% (=48 mmol/mol) as measured by the central<br> laboratory at screening.<br><br> 4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or<br> treatment with glucose lowering agent started within 3 months before screening.<br><br> 5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.<br><br> 6. Known clinically significant gastric emptying abnormality (e.g. severe diabetic<br> gastroparesis or gastric outlet obstruction).<br><br> 7. History of either chronic or acute pancreatitis or elevation of serum lipase or<br> amylase >2x upper limit of normal (ULN) as measured by the central laboratory at<br> screening.<br><br> 8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple<br> endocrine neoplasia syndrome type 2 (MEN 2).<br><br>Further exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in body weight from baseline to Week 76;Achievement of body weight reduction =5% (yes/no) from baseline to Week 76
- Secondary Outcome Measures
Name Time Method