A study to test whether BI 456906 helps people living with overweight or obesity who do not have diabetes to lose weight

JRCT ID: jRCT2031230552

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,Finland,Japan,Germany,Japan,Korea, Republic of,Japan,Netherlands,Japan,New Zealand,Japan,Poland,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 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) >=30 kg/m2 at screening, OR BMI >=27 kg/m2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:
-Hypertension
-Dyslipidaemia
-Obstructive sleep apnoea
-Others.
3. History of at least one self-reported unsuccessful dietary effort to lose body weight.

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. Glycosylated haemoglobin A1c (HbA1c) >=6.5% (>=48 mmol/mol) as measured by the central laboratory at screening.
4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before screening.
5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
6. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
7. 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.
8. 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): NCT06066515