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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230552

Enrollment

200

Registered

2024-01-10

Start date

2024-01-16

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Drug: BI 456906 Drug: Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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).

Design outcomes

Primary

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

Countries

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

Contacts

Public ContactShizuko Kawahara

Boehringer Ingelheim

medchiken.jp@boehringer-ingelheim.com+81-120-189-779

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026