A study to test whether BI 456906 helps people living with overweight or obesity who also have diabetes to lose weight

JRCT ID: jRCT2031230551

Registered date:10/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 16/01/2024
• Target sample size: 200
• Countries of recruitment: Australia,Japan,Belgium,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Korea, Republic of,Japan,Netherlands,Japan,New Zealand,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: BI 456906
Drug: Placebo

Outcome(s)

Primary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Ishibashi Yukiko
• Secondary ID(s): NCT06066528