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

JRCT ID: jRCT2031230522

Registered date:21/12/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 15/01/2024
• Target sample size: 240
• 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
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

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. 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

Related Information

• Primary Sponsor: Kenmochi Hiroki
• Secondary ID(s): NCT06176365