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 without type 2 diabetes

A study to test whether BI 456906 helps people living with overweight or obesity who do not 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) >=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.

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).

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

Dec. 11, 2023

Yes

Australia/Belgium/Canada/China/Finland /Germany/ Korea, Republic of/Netherlands/New Zealand/Poland/Sweden/United Kingdom/United States