A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight

Korábbi kezelés

• Body weight change (self-reported) \>5% within 3 months before screening.
• Treatment with any medication for the indication obesity within 3 months before screening.
• Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, or prior surgery of the GI tract that could interfere with body weight The following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening, (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \>1 year before screening, (5) appendectomy, (6) simple hernia repair, or (7) cholecystectomy
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, verified by an eye examination within 3 months prior to screening or in the period between screening and randomisation Further exclusion criteria apply.

Más betegség

• Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome) (B) Diabetes-related for participants with T2DM:

Laborértékek

• Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before screening (i.e. insulin, amylin analogues, glucagon-like peptide-1 receptor (GLP- 1R)) agonists, GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations, and dipeptidyl peptidase 4 inhibitor (DPP-4i))
• New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial

Egyéb

• (A) Obesity:

• Male or female, age ≥18 years at the time of signing informed consent.
• Body mass index (BMI) ≥28 kg/m\^2 at screening, OR BMI ≥24 kg/m\^2 at screening with the presence of at least one of the following weight-related complications:
  • Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 mmHg and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure)
  • Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high density lipoprotein (HDL) cholesterol \<40 mg/dL (\<1.0 mmol/L) for men or HDL cholesterol \<50 mg/dL (\<1.3 mmol/L) for women)
  • Obstructive sleep apnoea
  • Cardiovascular disease (CVD) (e.g. heart failure (HF) with New York Heart Association (NYHA) functional class II-III, history of ischaemic or haemorrhagic stroke or cerebrovascular revascularisation procedure \[e.g. carotid endarterectomy and/or stent\], myocardial infarction (MI), coronary artery disease, or peripheral vascular disease)
  • Type 2 diabetes mellitus (T2DM) diagnosed at least 180 days prior to screening (glycosylated haemoglobin A1c (HbA1c) ≥6.5% (48 mmol/mol) and \<10% (86 mmol/mol), and fasting plasma glucose (FPG) ≤11.1 mmol/L 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 (SGLT2i) inhibitor, acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to local label
  • Non-alcoholic steatohepatitis (NASH), as assessed in medical records by histological liver assessment (within the last 6 months)
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the participant information.
  • Further inclusion criteria apply.