臨床研究等提出・公開システム

A Phase 3, randomised, double-blind, parallel-group, 76-week, efficacy and safety study of BI 456906 administered subcutaneously compared with placebo in participants with overweight or obesity and type 2 diabetes mellitus

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

Ishibashi Yukiko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Kawahara Shizuko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

Jan. 16, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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).

Both

Obesity

Drug: BI 456906
Drug: Placebo

- 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

Dec. 15, 2023

Yes

Australia/Belgium/Canada/China/Czech Republic/Denmark/Finland /Germany/Greece /Hungary/Korea, Republic of/Netherlands /New Zealand/Poland/Spain /Sweden/United Kingdom/United States