Status:
ACTIVE_NOT_RECRUITING
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² or more and at least one health problem related to their weig...
Eligibility Criteria
Inclusion
- 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
- Body mass index (BMI) ≥30 kg/m\^2 at screening, OR BMI ≥27 kg/m\^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:
- Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (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 low-density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high-density lipoprotein (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
- Others.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Further inclusion criteria apply.
Exclusion
- 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.
- Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before the screening up to and including the randomisation visit.
- Heart failure (HF) with New York Heart Association (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).
- Further exclusion criteria apply.
Key Trial Info
Start Date :
November 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2026
Estimated Enrollment :
726 Patients enrolled
Trial Details
Trial ID
NCT06066515
Start Date
November 25 2023
End Date
February 13 2026
Last Update
January 9 2026
Active Locations (118)
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1
EmVenio Research-Phoenix-69743
Phoenix, Arizona, United States, 85032
2
Encompass Clinical Research, Spring Valley
Spring Valley, California, United States, 91978
3
Diablo Clinical Research
Walnut Creek, California, United States, 94598
4
Yale University School of Medicine
New Haven, Connecticut, United States, 06519