臨床研究等提出・公開システム

A Phase III, randomised, double-blind, parallel-group, 76-week, efficacy and safety study of BI 456906 administered subcutaneously compared with placebo in patients with obesity disease in Japanese

A study to test whether BI 456906 helps Japanese people living with obesity disease

Kenmochi Hiroki

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. 15, 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
2. BMI >=35 kg/m2 at screening with the presence of at least one obesity-related co-morbidity (treated or untreated) according to the Japan Society for the Study of Obesity (JASSO) guideline*, OR
BMI >=27 kg/m2 at screening with the presence of at least two obesity-related co-morbidities (treated or untreated) according to the JASSO guideline*
For all trial patients, at least one co-morbidity should be the following (i)-(iii):
i. T2DM
-Diagnosed with T2DM (defined as HbA1c >=6.5% [>=48 mmol/mol]) at least 180 days prior to screening
-HbA1c >=6.5% (48 mmol/mol) and <10% (86 mmol/mol) as measured by the central laboratory at screening
-Currently treated with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT-2i), acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT-2i, acarbose, sulfonylurea, or glitazone) according to local label
ii. Hypertension
iii. Dyslipidemia
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. QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
4. Heart failure (HF) with New York Heart Association (NYHA) functional class IV

Both

Obesity

Drug: BI 456906
Drug: Placebo

Obesity

Percentage change in body weight from baseline to Week 76
Achievement of body weight reduction >= 5% (yes/no) from baseline to Week 76

Nov. 16, 2023

Yes

Researchers can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from our clinical studies.

None