Status:
ACTIVE_NOT_RECRUITING
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Obesity
Diabetes Mellitus, Type 2
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 of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated onl...
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) ≥27 kg/m\^2 at screening.
- Diagnosed with Type 2 diabetes mellitus (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) per treatment guidelines.
- 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.
- Treatment with any medication for indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor \[DPP-4il).
- 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 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 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2026
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT06066528
Start Date
November 27 2023
End Date
April 3 2026
Last Update
December 12 2025
Active Locations (143)
Enter a location and click search to find clinical trials sorted by distance.
1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
EmVenio Research-Atlanta-69582
Phoenix, Arizona, United States, 85032
3
Encompass Clinical Research, Spring Valley
Spring Valley, California, United States, 91978
4
Diablo Clinical Research
Walnut Creek, California, United States, 94598