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

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) >=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
•History of at least one self-reported unsuccessful dietary effort to lose body weight.

•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.
•Glycosylated haemoglobin A1c (HbA1c) >=6.5% (>=48 mmol/mol) as measured by the central laboratory at screening.
•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.
•Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
•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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