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

Boehringer Ingelheim0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年6月3日

适应症

试验速览

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•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.
•Body mass index (BMI) >=27 kg/m2 at screening.
•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.
•HbA1c >=6.5% (>=48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening.
•Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines.
•History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.

•Body weight change (self-reported) of >5% within 3 months before screening.
•Treatment with any medication for the indication obesity within 3 months before screening.
•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).
•Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
•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.
•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

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