Obesity
Conditions
Interventions
Sponsors
Ishibashi Yukiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Body mass index (BMI) >=27 kg/m2 at screening. 3. 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. 4. HbA1c >=6.5% (>=48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening. 5. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines. 6. History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.
Exclusion criteria
Exclusion criteria: 1. Body weight change (self-reported) of >5% within 3 months before screening. 2. Treatment with any medication for the indication obesity within 3 months before screening. 3. 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). 4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). 5. 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. 6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage change in body weight from baseline to Week 76 - Achievement of body weight reduction >=5% (yes/no) from baseline to Week 76 Key secondary | — |
Countries
Australia, Belgium, Canada, China, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactShizuko Kawahara
Boehringer Ingelheim
Outcome results
None listed